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Article

COVID-19 in the Neonatal Period in a Reference Maternity for High-Risk Pregnancy: A Hospital-Based Case-Control Study

by
Roseane Lima Santos Porto
1,
Sonia Oliveira Lima
1,
Cristiane Costa da Cunha Oliveira
2,
Vera Lúcia Corrêa Feitosa
3,
Raissa Pinho Morais
1,
Aline de Siqueira Alves Lopes
3,
Ana Jovina Barreto Bispo
3 and
Francisco Prado Reis
1,*
1
Department of Graduate Studies in Health and Environment, Tiradentes University (UNIT), Aracaju 49032-490, Sergipe, Brazil
2
International Network on Collective Health and Intercultural Health, Amecameca 56903, State of Mexico, Mexico
3
Department of Medicine and Dentistry, Federal University of Sergipe (UFS), Aracaju 49100-000, Sergipe, Brazil
*
Author to whom correspondence should be addressed.
COVID 2026, 6(1), 11; https://doi.org/10.3390/covid6010011
Submission received: 21 October 2025 / Revised: 18 November 2025 / Accepted: 19 November 2025 / Published: 6 January 2026
(This article belongs to the Section COVID Clinical Manifestations and Management)
Review Reports Versions Notes

Abstract

COVID-19 in newborns presents a multifaceted clinical spectrum, with the potential for severe outcomes. This study aimed to evaluate the clinical evolution and hospital outcomes of neonates with a molecular diagnosis of COVID-19. A case-control study was conducted in a public referral maternity hospital for high-risk pregnancies. Two controls were selected for each case, matched by sex and gestational age. Variables related to birth data, symptoms, and clinical progression were collected from medical records and analyzed statistically, with crude and adjusted relative risks calculated using Poisson regression with robust standard errors. A total of 25 neonates with confirmed SARS-CoV-2 infection were identified among 875 newborns. Compared with controls, infected neonates had a longer hospital stay (median of 19 days vs. 8 days; p < 0.001) and higher readmission rates (16% vs. 0%; p = 0.03). After adjusting for potential confounders, COVID-19 infection was associated with a 2.41-fold higher risk of neonatal death (95% CI: 1.24–4.67; p = 0.009). No evidence of vertical transmission was found. These findings suggest that neonates with COVID-19 may experience longer hospitalizations and an adjusted higher risk of mortality, emphasizing the need for vigilant surveillance and supportive care. However, given the observational design of the study, these results indicate associations rather than causal relationships. Understanding the clinical behavior of COVID-19 in this population—characterized by inherently low immunity—and recognizing its interaction with other neonatal conditions are essential for improving hospital management and outcomes.

1. Introduction

The identification of the novel coronavirus (SARS-CoV-2) in December 2019 triggered global concern due to the rapid increase in cases resulting from the high transmissibility and lethality of this virus [1,2]. The epidemic pattern of COVID-19 varied considerably across different countries and regions [3]. Moreover, distinct population subgroups were affected in different ways—either due to economic, social, and cultural barriers or intrinsic physiological factors—which led the World Health Organization (WHO) [1] to identify risk groups for greater disease severity [2,4].
With regard to the neonatal population, the impacts of COVID-19 can be examined from several perspectives. During the prenatal period, COVID-19 had important repercussions on maternal health care, leading to a reduction in procedures related to this stage, such as access to prenatal and postpartum consultations and rapid testing, among others [5]. Another aspect to be considered is the occurrence of complications in newborns of mothers infected with SARS-CoV-2. Several studies have shown that COVID-19 during pregnancy is associated with outcomes such as prematurity and low birth weight [6].
Furthermore, concerning possible long-term consequences for newborns, findings from the study by Edlow et al. [7] suggest that maternal exposure during pregnancy—particularly in the third trimester—may be associated with alterations in the neurological development of newborns, mainly involving motor, speech, and language functions.
Regarding the clinical spectrum in this population subgroup, cases range from asymptomatic or mild forms to severe presentations characterized by Severe Acute Respiratory Syndrome (SARS), resulting in a high proportion of admissions to Intensive Care Units (ICUs) and in-hospital deaths [8,9].
SARS-CoV-2 continues to circulate and remains a threat to the population, making it imperative to maintain early warning systems, surveillance, variant tracking, vaccination coverage, and timely clinical care, among other measures, to keep the disease under control [10].
To date, most studies have focused on the repercussions of COVID-19 during pregnancy for the newborn. Therefore, the present study aimed to evaluate the clinical evolution and hospital outcomes of neonates with a molecular diagnosis of COVID-19, since an adequate understanding of the behavior of SARS-CoV-2 infection in this population may contribute to better disease management, with potential impacts on the neonatal component of infant mortality rates in Brazil.

2. Methods

This is a retrospective, hospital-based case-control study conducted at Nossa Senhora de Lourdes Maternity Hospital (MNSL), located in Sergipe, a state in northeastern Brazil. The study population comprised all live births at the institution between March and November 2020.
MNSL is the only maternity hospital within the state’s Unified Health System (SUS) that serves as a referral center for high-risk pregnancies, with an annual average of 423 births per month. The institution played a key role in neonatology at the state level during the pandemic, as it established six exclusive intensive care beds for neonates suspected or confirmed to have COVID-19, in addition to the 34 pre-existing intensive care beds.
Case selection was carried out through an analysis of databases from the institution’s Diagnostic and Therapeutic Support Service and the Hospital Infection Control Service. Eligible participants included all newborns (NBs) who underwent molecular RT-PCR testing (Reverse Transcription Polymerase Chain Reaction) on a nasopharyngeal swab and had a detectable result for SARS-CoV-2 during the neonatal period, defined as up to 28 completed days of life, within the study timeframe. This included those born at MNSL, transferred from other institutions, or readmitted after discharge.
Clinical criteria for RT-PCR testing included suspected or confirmed maternal SARS-CoV-2 infection, the presence of signs and symptoms suggestive of COVID-19, and instances where the newborn had contact with a symptomatic individual or a person with a confirmed COVID-19 diagnosis other than the mother.
The control group consisted of newborns born at the same institution who had no diagnosis of COVID-19 during the neonatal period. Two controls were selected for each identified case, born subsequently, and matched by sex and gestational age range, according to the criteria established by the Brazilian Ministry of Health [11]. Control selection was performed by reviewing the institution’s birth registry.
After identifying cases and controls, the medical records of the newborns and their respective mothers were retrieved from the Medical Records and Statistics Service. Data were extracted using a structured collection instrument designed to record the variables under analysis. Independent variables included presentation at birth, sex, anthropometric data at birth, Apgar score, need for resuscitation at birth, and destination unit after delivery. The dependent variable consisted of clinical and hospital course, represented by diagnoses during hospitalization, treatments received, and hospital outcome.
Categorical variables were described using absolute and relative frequencies, while continuous variables were summarized using measures of central tendency (mean and median) and measures of dispersion (standard deviation and interquartile range).
The hypothesis of independence between categorical variables was tested using Pearson’s Chi-square and Fisher’s Exact tests. The assumption of normality for continuous variables was verified using the Shapiro–Wilk test. As normal distribution was not confirmed, the equality of medians was assessed using the Mann–Whitney U test for two independent samples. Additionally, Cohen’s h effect sizes were calculated for proportions, interpreted as follows: |h| < 0.2, negligible; 0.2 < |h| < 0.5, small; 0.5 < |h| < 0.8, medium, and |h| > 0.8, large.
Furthermore, rank-biserial correlation effect sizes were calculated to assess the strength of evidence in favor of a given hypothesis. Crude and adjusted relative risks for neonatal death were estimated using Poisson regression with robust standard errors. The level of statistical significance was set at 5%. Data analyses were performed using R software (R Core Team, 2022; version 4.2.1).
The study was approved by the Research Ethics Committee (CEP) of Tiradentes University (UNIT), Aracaju, Sergipe, Brazil, under the Certificate of Ethical Approval (CAAE) number 48132520.6.0000.5371.

3. Results

During the study period, 3894 live births occurred at MNSL, of which 25 (0.64%) were diagnosed with COVID-19 during the neonatal period, resulting in an incidence rate of 64.2 per 10,000 live births (95% CI: 43.5–94.6). This value should be interpreted as an incidence among all live births at the institution, not adjusted for the unknown testing coverage. The control group consisted of 50 neonates, matched by sex and gestational age range. No newborns were excluded from the sample.
The maternal sociodemographic and obstetric characteristics of cases and controls are presented in Table 1. The variables analyzed showed a homogeneous distribution between the two groups. In both groups, most pregnant women were multigravidas, carrying a singleton pregnancy, and none had a positive rapid test for Hepatitis B.
Table 2 presents the distribution of maternal RT-PCR molecular testing. The test was performed in 17 symptomatic patients and in one asymptomatic patient, resulting in a positivity rate of 72.2%. In the statistical analysis conducted with the control group, significant differences were found regarding the presence of signs and symptoms suggestive of COVID-19 (68% vs. 2%; p < 0.001; h = 1.065) and detectable RT-PCR results (52% vs. 0%; p < 0.001; h = 1.611).
Table 3 presents the clinical characteristics of the newborns at birth, with no statistically significant differences observed among the analyzed variables.
The medical records of the newborns were analyzed considering the possible signs and symptoms that could be part of the clinical spectrum of SARS-CoV-2 infection. The findings analyzed between the groups were statistically significant (16 [64%] vs. 3 [6%], p < 0.001; h = 1.36). Table 4 shows that there was a higher prevalence of these manifestations in the group of newborns with COVID-19, with statistically significant differences (p < 0.05) for the following signs and symptoms: fever (20% vs. 0%; p = 0.003); respiratory distress not related to neonatal pathologies, infection, or sepsis (16% vs. 0%; p = 0.01); pericardial effusion (12% vs. 0%; p = 0.034); diarrhea (12% vs. 0%; p = 0.034); and poor sucking (20% vs. 2%; p = 0.014).
The presence of signs and symptoms suggestive of COVID-19 was one of the medical criteria for indicating RT-PCR testing for SARS-CoV-2. However, asymptomatic cases underwent molecular testing for other reasons, such as being the newborn of a suspected or confirmed mother, or having contact with a confirmed case. Among newborns with COVID-19, the median age at the time of RT-PCR collection was 6 days (IQR: 3–13). Of these, 14 (56%) swabs were collected during the early neonatal period (up to 6 days of life), including two within the first 24 h after birth, and 11 (44%) during the late neonatal period (7 to 27 days of life).
Table 5 presents the clinical outcomes of the newborns. Only those diagnosed with COVID-19 required hospital readmission, with a median age of 13 days (IQR: 7.5–19.5). The four readmitted newborns exhibited signs and symptoms suggestive of COVID-19 as the reason for the new hospitalization, including fever, cough, and diarrhea. Significant results were also observed for age at hospital discharge (19 [9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27] vs. 8 [3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27]; p = 0.047; R = 0.283), with a higher median age among the cases. Among the newborns who died, 3 (75%) had COVID-19 listed as the underlying cause on the death certificate.
Table 6 presents the crude and adjusted relative risks for the case/control groups and newborn outcomes (death/survival). Individually, there was no increased risk of death among newborns with COVID-19 (RR: 2.00; 95% CI: 0.54–7.34; p = 0.296). However, after including adjustment variables (5-min Apgar score, classified birth weight, classified gestational age, need for neonatal resuscitation, and mode of delivery), a significant increase in risk was observed (RR: 2.52; 95% CI: 1.36–4.64; p = 0.003). When all adjustment variables were included, the COVID-19 group had a 2.41-fold higher risk of neonatal death (95% CI: 1.24–4.67; p = 0.009). Therefore, newborns with COVID-19—considering 5-min Apgar score, classified birth weight, classified gestational age, need for neonatal resuscitation, mode of delivery, maternal age, and rupture of membranes—showed a higher risk of death.

4. Discussion

The incidence of COVID-19 cases among newborns born at MNSL (64.2 per 10,000 live births) in the present study was higher than that reported by some authors in Brazil and other countries. Pereira et al. [9], analyzing registered cases of severe acute respiratory syndrome (SARS) resulting from COVID-19 in 2020 and 2021, found incidence rates among the neonatal population of 11.13 per 10,000 and 7.2 per 10,000, respectively. A population-based study of newborns infected with SARS-CoV-2 in the United Kingdom reported an incidence of 5.6 per 10,000 live births among babies who received hospital care [12]. In the United States—the country with the highest number of COVID-19 cases worldwide—Devin et al. [13], analyzing data from more than one million newborns diagnosed with COVID-19, reported an incidence of 9.11 per 10,000 live births. In Norway, one of the countries least affected by the pandemic, only three infants with SARS-CoV-2 infection were admitted to a neonatal unit during the first year of the pandemic, with an incidence of 0.8 per 10,000 live births [14].
Some general birth characteristics observed in the newborns in the present study, such as gestational age, sex, and fifth-minute Apgar scores, were similar to those described by Raschetti et al. [15]. The median birth weight reported by those authors was higher than that found in the present study but remained within the range considered adequate for birth weight.
The clinical manifestations of COVID-19 in neonates are highly nonspecific, making diagnostic suspicion particularly challenging when considering both neonatal pathologies, such as respiratory distress and neonatal infection and/or sepsis, as well as viral respiratory conditions, including those caused by the Respiratory Syncytial Virus, which commonly occur in newborns and infants, sometimes with considerable severity. In the present study, among the 16 newborns who presented clinical symptoms, most (nine) did not undergo RT-PCR testing based on initial diagnostic suspicion, with some of the clinical findings being associated only after obtaining a positive molecular test result. Furthermore, the possibility of co-infection between respiratory viruses and coronavirus must be considered.
The clinical findings of COVID-19 in infected infants may be explained by other associated conditions, such as prematurity, which can evolve with respiratory symptoms resulting from respiratory distress syndrome. Therefore, data regarding the clinical symptomatology of COVID-19 may be underestimated [24].
In symptomatic newborns, various nonspecific signs and symptoms have been described in the literature, including thermal instability, tachycardia, tachypnea, respiratory distress, cough, apnea, abdominal distension, feeding intolerance, lethargy, and vomiting, among others [12,25].
Leibowitz et al. [16], in evaluating the clinical characteristics of infants with respiratory infections caused by viruses other than SARS-CoV-2—such as rhinovirus, respiratory syncytial virus, and enterovirus—compared to those with COVID-19, found that the latter were more likely to present with nonspecific symptoms such as lethargy and feeding difficulties.
In both newborn groups analyzed in this study, resuscitation rates in the delivery room were high, with at least positive pressure ventilation using a manual resuscitator being required. This finding contrasts with the 10% reported in the literature [17] and may reflect the institutional profile focused on high-risk pregnancies.
Regarding gestational age—one of the matching criteria used in the study—it was observed that 70% of newborns had a gestational age below 37 weeks. The rate found in the present study differs from those reported in Brazil and worldwide. Although there is considerable variation in global preterm birth rates across regions and countries, the rate of prematurity reported in Brazil in 2021 was 11.49%, which is higher than the global average reported by the World Health Organization (WHO) [10], estimated at 9.9% of live births [18,19,20]. In Sergipe, the rate of prematurity was similar to that reported by the WHO [20], at 9.8% in the year of the study [21].
In the context of COVID-19, prematurity has emerged as one of the complications associated with SARS-CoV-2 infection during pregnancy [22,23]. Most COVID-19–related preterm births have been medically induced due to the presence of maternal disease, although the rate of spontaneous preterm birth remains unknown [14].
The clinical presentation of COVID-19 in neonates can be highly variable and nonspecific, ranging from asymptomatic cases to critically ill newborns [8]. n contrast to the data found in the present study, 36% of newborns with a confirmed diagnosis of COVID-19 showed no symptoms or suggestive clinical signs. In the study by Gale et al. [12], which included 66 infants diagnosed with SARS-CoV-2 infection within the first 28 days of life, only 11% of cases were asymptomatic. In these infants, RT-PCR testing was performed solely due to suspected maternal infection.
Because the clinical manifestations of COVID-19 in infected infants may be explained by other associated conditions—such as prematurity, which can present with respiratory symptoms secondary to respiratory distress syndrome—the data regarding the clinical symptomatology of COVID-19 may be underestimated [24].
In symptomatic newborns, several nonspecific signs and symptoms have been described in the literature, such as thermal instability, tachycardia, tachypnea, respiratory distress, cough, apnea, abdominal distension, feeding intolerance, lethargy, and vomiting, among others [12,25]. Nevertheless, certain specific conditions may contribute to more severe clinical presentations of COVID-19 among neonates. Graff et al. [26], in a retrospective cohort study, demonstrated that age 0–3 months was a significant demographic predictor of the need for hospitalization and respiratory support. Conditions such as immunosuppression, gastrointestinal disease, and a history of preterm birth, among others, were also associated with the need for hospital admission.
Fever has been the most frequently reported clinical sign among symptomatic neonates in the literature [15,27,28]. This finding was also the most common in the medical records reviewed in the present study. Other respiratory signs and symptoms—such as respiratory failure, cough, tachypnea, and chest retractions—gastrointestinal manifestations, mainly represented by diarrhea, vomiting, and feeding intolerance; neurological manifestations, including hypertonia, irritability, and lethargy; as well as nonspecific cardiovascular symptoms, such as hypotension and tachycardia; and, less frequently, dermatological manifestations, have also been reported in the literature as resulting from SARS-CoV-2 infection [8,14,15,29]. Some of these signs and symptoms were found and described in the current study.
Respiratory distress, characterized by tachypnea and chest retractions, was the predominant respiratory symptom among the newborns evaluated. This finding was also reported by authors such as Raschetti et al. [15] e Devin et al. [13]. According to Akin et al. [29], who evaluated 176 neonates with COVID-19, cough was the most prevalent respiratory manifestation, present in 21.6% of infected neonates, followed by tachypnea and chest retractions.
Pleural effusion was identified on imaging in one infant belonging to the COVID-19 group. During the neonatal period, pleural effusion can have multiple etiologies, ranging from congenital causes—such as fetal hydrops—to acquired conditions [30]. Armanpoor and Armanpoor [31] described the case of a neonate born at 31 weeks of gestational age who developed worsening respiratory symptoms on the fifth day of life due to a right-sided pleural effusion. A molecular test for COVID-19 was performed simultaneously, confirming the infection and suggesting that the pleural effusion was secondary to SARS-CoV-2 infection.
Among the gastrointestinal manifestations, diarrhea was the most frequent finding. This result is consistent with reports by authors such as Gale et al. [12], García et al. [27] and Raschetti et al. [15].
Cardiovascular manifestations in neonates with COVID-19 include tachycardia, hypotension, and bradycardia, which are highly nonspecific symptoms [15,27]. However, in cases of multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19—a rare condition that can affect individuals from birth to 19 years of age—clinical signs of multisystem involvement, including cardiovascular compromise, are present and are associated with high morbidity and mortality [32,33].
In the present study sample, one neonate developed tachypnea and cyanosis on the twelfth day of life and was subsequently diagnosed with COVID-19 by RT-PCR. Forty-eight hours after diagnosis, the infant developed a cardiac murmur, and echocardiography revealed pericardial thickening in the posterior and lateral walls of the left ventricle, consistent with acute pericarditis, which was attributed to SARS-CoV-2 infection. Although pericarditis falls within the spectrum of systemic manifestations of MIS-C, the absence of other clinical and laboratory criteria required for diagnosis precluded confirmation of this condition.
Pericardial effusion was another possible cardiac manifestation observed in two infected neonates in the study, potentially related to SARS-CoV-2 infection. This condition has been described in the literature as an extrapulmonary manifestation of COVID-19 in the adult population; however, it remains unclear whether it is related to underlying myocarditis or pericarditis, and it is recommended that other causal factors for the condition be ruled out [34]. No reports were found in the literature describing pericardial effusion as a clinical manifestation of COVID-19 in neonates, making it difficult to clearly determine whether this finding resulted from SARS-CoV-2 infection or from underlying pericarditis and/or myocarditis.
In the neonates with SARS-CoV-2 infection included in the present study, no neurological manifestations commonly reported in the literature were identified. This may be related to the nonspecific nature of some symptoms, which also occur in other clinical conditions frequently observed in newborns, such as neonatal sepsis, which can present with lethargy, irritability, seizures, hypotonia, among others [35]. Nevertheless, sucking deficit was one of the symptoms that showed a statistically significant difference between groups, being more prevalent among the cases.
In a literature review, Armas-Navarro et al. [36], who investigated adult patients admitted to intensive care units to identify risk factors associated with dysphagia, observed that this symptom was present in nearly half of the studied sample, with a higher prevalence among patients hospitalized due to COVID-19. Significant odds ratios for the development of dysphagia included COVID-19, prolonged ICU stay, and a history of neurological conditions, among others. To date, these oral dysfunctions have not been reported in the literature as being associated with COVID-19 in neonates.
Among the newborns with SARS-CoV-2 infection in the present study, more than half had their diagnosis confirmed during the early neonatal period, with a median age of 6 days. Two cases tested positive by molecular assay within less than 24 h after birth. In the sample reported by Gale et al. [12], the median age was 9.5 days, with two cases diagnosed by nasopharyngeal swab collected within 12 h of life, suggesting possible vertical transmission. Devin et al. [13] reported an average time to diagnosis of 14.5 days, with two newborns diagnosed with COVID-19 by oropharyngeal swab collected within the first 24 h of life, suggesting possible vertical transmission or perinatal colonization.
According to the criteria defined by the WHO [37] for the diagnosis of intrauterine infection, the two cases in the present study in which oropharyngeal swab samples were collected before 24 h of life and yielded positive results could not be considered as resulting from this route of infection, since there was no record of viral persistence and/or immune response detected by RT-PCR in a sterile sample collected between 24 and 48 h of life.
Suspected or confirmed maternal SARS-CoV-2 infection was the most common indication for RT-PCR testing in the sample studied, occurring in 12 (48%) of the newborns. The findings of the present study were consistent with the literature, which identifies postnatal transmission through environmental exposure as the most frequent route of transmission in newborns [1,3,29].
Despite the major impact of COVID-19 on global health and morbidity and mortality rates, data on infant mortality showed no significant changes when comparing the pre-pandemic period (2019) with 2020 and 2021. Infant mortality rates were 12.4%, 11.5%, and 11.5% for the respective years, with approximately 66% of deaths attributed to clearly preventable causes across all three years evaluated [38].
In the present study, among newborns infected with SARS-CoV-2, COVID-19 was identified as the underlying cause in 3 (12%) deaths. Data on deaths due to SARS-CoV-2 infection in the neonatal population vary across studies. Akin et al. [29] reported a mortality rate of 0.6%—their sample included a single death of an infant with trisomy 21 and congenital heart disease, in whom the cause of death was severe acute respiratory syndrome (SARS) associated with sepsis. Among the patients evaluated by Devin et al. [13] there was also one death (0.1%), probably related to MIS-N. In other studies, no deaths associated with COVID-19 were reported [12,15,23].
Furthermore, data from Brazil have shown death rates among children and newborns that were considerably higher than those reported in other countries [39]. Pereira et al. [9] analyzed data on Brazilian newborns with severe acute respiratory syndrome (SARS) due to COVID-19 using records from the Influenza Epidemiological Surveillance Information System, which reported 793 cases in 2020 and 856 in 2021. The proportion of newborns admitted to the ICU and those with hospital death as an outcome was similar in both periods, with rates of 55.6% and 55.9% for ICU admission and 16.8% and 16.4% for hospital mortality, respectively.
Lopes et al. [39], in a study based on data from the state of Sergipe, observed that among children and adolescents under 12 years of age, data up to September 2020 showed a mortality rate of 0.48 per 10,000 inhabitants, with a higher proportion among infants under 12 months—4.41 per 10,000 inhabitants. These rates were higher than those observed in other regions of Brazil and in other countries, such as the United States and the United Kingdom, particularly in the population under 12 months of age.
In the present study, SARS-CoV-2 infection, when evaluated in isolation, could not be considered a risk factor for neonatal outcome (death/survival), although three newborns had COVID-19 listed as the underlying cause of death on their death certificates. Previously cited studies have reported low mortality rates among neonates with COVID-19 [12,13,29]. However, the data from this study indicate that the relative risk becomes significant when other clinical conditions of the newborn act as contributing factors to the outcome. The literature describes several factors that may be associated with neonatal mortality, including gestational age, birth weight, 5-min Apgar score, respiratory distress syndrome, congenital malformations, and infection, among others [40,41].
Among the factors evaluated in this study as related to the relative risks for neonatal outcome (death/survival) were the 5-min Apgar score, gestational age, birth weight, need for neonatal resuscitation, mode of delivery, maternal age, and rupture of membranes. Therefore, the need for a thorough and comprehensive assessment of each patient is evident, since a single RT-PCR test for COVID-19 alone cannot determine clinical outcomes during the hospital course of these newborns. Although the adjusted analysis indicated a statistically significant association between COVID-19 and neonatal death when other clinical conditions were considered, this finding should be interpreted with caution given the exploratory nature of the study and the limited sample size. It is important to emphasize that, based on the available data, COVID-19 should not be interpreted as the primary cause of death in most cases; rather, it may act as a concomitant factor that exacerbates pre-existing neonatal conditions. Additionally, the adjusted model included eight deaths for seven covariates, resulting in a low events-per-variable (EPV) ratio, which further reinforces the exploratory nature of these findings. The results suggest a potential association rather than a causal relationship, underscoring the need for further research with larger cohorts to clarify this link.
Despite the limitations of this study, data were collected retrospectively from medical and multidisciplinary records in clinical charts, which may have resulted in incomplete information. Moreover, underreporting of cases may have occurred due to the absence of a universal screening protocol and the limited availability of molecular diagnostic tests during the first year of the pandemic, when diagnostic resources were primarily directed toward more severe patients. During that initial period, knowledge about COVID-19 in the neonatal population was limited, which may have affected diagnostic suspicion of the disease—particularly given the presence of manifestations similar to those observed in other neonatal conditions. In addition, respiratory symptoms caused by other viruses commonly found in the pediatric population may resemble those of COVID-19.
Considering the findings of the present study and recognizing that SARS-CoV-2 still poses a global threat, the results highlight the importance of diagnosing COVID-19 in this population, which is often affected by other viruses that commonly cause respiratory symptoms. Neglecting this diagnosis may increase the risk of transmission to other individuals, especially those with comorbidities that predispose to unfavorable outcomes, and may facilitate the circulation of a virus with a high potential for mutation, possibly leading to new and severe outbreaks.
The findings of this study, although exploratory, highlight the importance of maintaining systematic surveillance and testing protocols for newborns at risk of SARS-CoV-2 exposure, particularly in referral maternity hospitals and neonatal intensive care units. Given the observational nature of the study, these associations should be interpreted cautiously and do not imply causation, but rather indicate possible relationships between neonatal COVID-19 and adverse clinical outcomes. Strengthening infection control practices and ensuring adequate personal protective equipment for healthcare professionals remain essential to prevent in-hospital transmission. Furthermore, these results reinforce the relevance of maternal vaccination strategies as an indirect protective measure for neonates, given their immature immune systems and dependence on maternal antibodies. Integrating such measures into Brazil’s broader neonatal and maternal health policies could contribute to reducing preventable deaths and improving the quality of neonatal care during and beyond pandemic periods.

Author Contributions

Conceptualization, R.L.S.P. and F.P.R.; Data curation, R.L.S.P. and F.P.R.; Formal analysis, R.L.S.P.; Investigation, R.L.S.P., V.L.C.F. and F.P.R.; Methodology, R.L.S.P., C.C.d.C.O. and F.P.R.; Project administration, F.P.R.; Supervision, F.P.R.; Validation, C.C.d.C.O. and F.P.R.; Visualization, F.P.R.; Writing—original draft, R.L.S.P. and F.P.R.; Writing—review & editing, R.L.S.P., S.O.L., C.C.d.C.O., R.P.M., A.d.S.A.L., A.J.B.B. and F.P.R. All authors have read and agreed to the published version of the manuscript.

Funding

No funding was received for this study.

Institutional Review Board Statement

The study was approved by the Research Ethics Committee (CEP) of Tiradentes University (UNIT), Aracaju, Sergipe, Brazil, under the Certificate of Ethical Approval (CAAE) number 48132520.6.0000.5371, 11 October 2021.

Informed Consent Statement

Free and informed consent was not required because the study was conducted using pre-established protocols. The confidentiality of participants’ data was strictly preserved.

Data Availability Statement

The data generated during this study are not publicly available because they are part of the internal protocols of the maternity hospital where the study was conducted.

Acknowledgments

The authors thank the Maternidade Nossa Senhora de Lourdes (MNSL) for the technical and logistical support provided during data collection. They also thank the research participants and all those who contributed directly or indirectly to the development of this study.

Conflicts of Interest

The authors declare no conflicts of interest.

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Table 1. Distribution of maternal sociodemographic and obstetric characteristics according to Case and Control groups—MNSL (Aracaju/SE—Mar. 2020 to Nov. 2020).
Table 1. Distribution of maternal sociodemographic and obstetric characteristics according to Case and Control groups—MNSL (Aracaju/SE—Mar. 2020 to Nov. 2020).
Group
Case Control p -Value
Maternal Age, Median (IQR)32 (28–37)30.5 (23–34)0.100 M
Place of Residence, n (%)
Capital12 (48)24 (48)1.000 Q
Inland municipalities12 (48)24 (48)
Other states1 (4)2 (4)
Area of Residence, n (%)
Urban12 (48)25 (50)1.000 F
Rural13 (52)25 (50)
Number of Prenatal Visits, Median (IQR)5.5 (3.5–8.5)6.5 (4–8.5)0.892 M
Number of Pregnancies, Median (IQR)2 (2–3)2.5 (2–3)0.972 M
Gravidity, n (%)
Primigravida4 (16)12 (24)0.555 F
Multigravida21 (84)38 (76)
Type of Pregnancy, n (%)
Singleton24 (96)45 (90)0.657 F
Twin1 (4)5 (10)
Rapid HIV Test, n (%)1 (4)1 (2)0.402 Q
Rapid Syphilis Test, n (%)2 (8)2 (4)0.815 Q
Comorbidities prior to pregnancy, n (%)11 (44)28 (56)0.341 F
Comorbidities during pregnancy, n (%)22 (88)44 (88)1.000 F
Alcohol/Tobacco Use, n (%)3 (12)6 (12)0.503 Q
Legend: n—absolute frequency. %—relative percentage frequency. IQR—Interquartile Range. M—Mann–Whitney test. F—Fisher’s Exact test. Q—Pearson’s Chi-square test.
Table 2. Distribution of COVID-19–related variables among pregnant women according to Case and Control groups—MNSL (Aracaju/SE—Mar. 2020 to Nov. 2020).
Table 2. Distribution of COVID-19–related variables among pregnant women according to Case and Control groups—MNSL (Aracaju/SE—Mar. 2020 to Nov. 2020).
Group
Case n (%) Control n (%) p -Value
Signs and symptoms suggestive of COVID-19, n (%)
Yes17 (68)1 (2)<0.001 F
No8 (32)49 (98)
Maternal RT-PCR, n (%)
Detectable13 (52)0 (0)<0.001 Q
Not detectable4 (16)1 (2)
Not collected8 (32)49 (98)
Legend: n—absolute frequency. %—relative percentage frequency. F—Fisher’s Exact test. Q—Pearson’s Chi-square test.
Table 3. Distribution of clinical data of newborns at birth according to Case and Control groups—MNSL (Aracaju-SE—Mar. 2020 to Nov. 2020).
Table 3. Distribution of clinical data of newborns at birth according to Case and Control groups—MNSL (Aracaju-SE—Mar. 2020 to Nov. 2020).
Group
Case Control p-Value
Amniotic sac, n (%)
Intact18 (72)22 (44)0.075 Q
Rupture < 18 h4 (16)16 (32)
Rupture ≥ 18 h3 (12)12 (24)
Mode of delivery, n (%)
Vaginal7 (28)24 (48)0.136 F
Cesarean section18 (72)26 (52)
Presentation, n (%)
Cephalic20 (80)42 (84)0.750 F
Breech5 (20)8 (16)
Sex, n (%)
Female12 (48)24 (48)1.000 F
Male13 (52)26 (52)
Gestational age, median (IQR)35 (33.1–37.1)35.8 (33–38.7)0.309 M
Classification of newborns
according to gestational age, n (%)
Extremely preterm (<28 weeks)2 (8)4 (8)1.000 Q
Moderately preterm (28–33 weeks and 6 days)6 (24)12 (24)
Late preterm (34–36 weeks and 6 days)9 (36)18 (36)
Term8 (32)16 (32)
Birth weight, median (IQR)2224 (1520–2754)2286.5 (1350–3039)0.762 M
Classification of newborns according to birth weight, n (%)
Extremely low birth weight1 (4)8 (16)0.323 Q
Very low birth weight5 (20)5 (10)
Low birth weight10 (40)17 (34)
Appropriate birth weight9 (36)20 (40)
Classification according
to adequacy of weight for gestational age, n (%)
SGA (Small for Gestational Age)7 (28)13 (26)0.385 Q
AGA (Appropriate for Gestational Age)14 (56)34 (68)
LGA (Large for Gestational Age)4 (16)3 (6)
Need for neonatal resuscitation, n (%)
Yes11 (44)15 (30)0.304 F
No14 (56)35 (70)
Five-minute Apgar score, median (IQR)9 (8–9)9 (9–10)0.137 T
Immediate postnatal care, n (%)
NICU/Intermediate Care Unit17 (68)23 (46)0.147 Q
Step-down Unit (UCINCo)3 (12)6 (12)
Rooming-in (ALCON)5 (20)21 (42)
Legend: n—absolute frequency. %—relative frequency percentage. IQ—Interquartile Range. M—Mann-Whitney Test. F—Fisher’s Exact Test. Q—Pearson’s Chi-Square Test. T—t-test for independent samples. Source: Research Data (2020).
Table 4. Signs and symptoms suggestive of COVID-19 according to the Case and Control groups—MNSL (Aracaju-SE—Mar. 2020 to Nov. 2020).
Table 4. Signs and symptoms suggestive of COVID-19 according to the Case and Control groups—MNSL (Aracaju-SE—Mar. 2020 to Nov. 2020).
Case
n (%) 		Control
n (%) 		p-Value
Signs and symptoms suggestive of COVID-19
Fever5 (20)0 (0)0.003
Respiratory manifestations
Nasal symptoms1 (4)0 (0)0.333
Cough1 (4)0 (0)0.333
Respiratory distress not related to neonatal pathologies, infection,
or sepsis		4 (16)0 (0)0.010
Pleural effusion1 (4)0 (0)0.333
Cardiac manifestations
Pericarditis1 (4)0 (0)0.333
Pericardial effusion3 (12)0 (0)0.034
Gastrointestinal manifestations
Diarrhea3 (12)0 (0)0.034
Upper gastrointestinal bleeding1 (4)1 (2)1.000
Cholestasis1 (4)2 (4)1.000
NEC (Necrotizing enterocolitis)2 (8)1 (2)0.256
Poor sucking5 (20)1 (2)0.014
Cutaneous manifestations1 (4)0 (0)0.333
Legend: n—absolute frequency. %—relative frequency percentage. Note: Fisher’s Exact Test. Source: Survey Data (2020).
Table 5. Clinical outcomes of newborns according to the Case and Control groups—MNSL (Aracaju-SE—Mar. 2020 to Nov. 2020).
Table 5. Clinical outcomes of newborns according to the Case and Control groups—MNSL (Aracaju-SE—Mar. 2020 to Nov. 2020).
Group
Case Control p-Value
Newborn readmission, n (%)
Yes4 (16)0 (0)0.010 F
No21 (84)50 (100)
If readmitted, age in days at readmission, Median (IQR)13 (7.5–19.5)
Newborn outcome, n (%)
Discharge21 (84)46 (92)0.429 F
Death4 (16)4 (8)
Age at outcome, Median (IQR)19 (9–27)8 (3–27)0.047 M
Discharge weight, Median (IQR)2624 (2220–3702)2428 (1980–3091)0.317 M
Legend: n—absolute frequency. %—relative frequency percentage. IQ—Interquartile Range. M—Mann-Whitney Test. F—Fisher’s Exact Test. Source: Research Data (2020).
Table 6. Crude and adjusted relative risks for case/control and newborn outcome (death/live birth)—MNSL (Aracaju-SE—Mar. 2020 to Nov. 2020).
Table 6. Crude and adjusted relative risks for case/control and newborn outcome (death/live birth)—MNSL (Aracaju-SE—Mar. 2020 to Nov. 2020).
Case/Control GroupRR(95%CI)p-Value
Crude2.000.54–7.340.296
Adjusted for Apgar at 5 min >71.030.36–2.940.952
Adjusted for Apgar at 5 min >7 and classified birth weight1.180.46–3.060.732
Adjusted for Apgar at 5 min >7, classified birth weight, and classified gestational age1.340.52–3.410.541
Adjusted for Apgar at 5 min >7, classified birth weight, classified gestational age, and need for neonatal resuscitation1.410.59–3.360.432
Adjusted for Apgar at 5 min >7, classified birth weight, classified gestational age, need for neonatal resuscitation, and mode of delivery2.521.36–4.640.003
Adjusted for Apgar at 5 min >7, classified birth weight, classified gestational age, need for neonatal resuscitation, mode of delivery, and maternal age2.381.28–4.400.006
Adjusted for Apgar at 5 min >7, classified birth weight, classified gestational age, need for neonatal resuscitation, mode of delivery, maternal age, and rupture of membranes2.411.24–4.670.009
Legend: RR—Relative Risk. 95% CI—95% confidence interval. Note: Poisson regression with robust standard errors. Source: Survey data (2020).
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Porto, R.L.S.; Lima, S.O.; da Cunha Oliveira, C.C.; Feitosa, V.L.C.; Morais, R.P.; de Siqueira Alves Lopes, A.; Bispo, A.J.B.; Reis, F.P. COVID-19 in the Neonatal Period in a Reference Maternity for High-Risk Pregnancy: A Hospital-Based Case-Control Study. COVID 2026, 6, 11. https://doi.org/10.3390/covid6010011

AMA Style

Porto RLS, Lima SO, da Cunha Oliveira CC, Feitosa VLC, Morais RP, de Siqueira Alves Lopes A, Bispo AJB, Reis FP. COVID-19 in the Neonatal Period in a Reference Maternity for High-Risk Pregnancy: A Hospital-Based Case-Control Study. COVID. 2026; 6(1):11. https://doi.org/10.3390/covid6010011

Chicago/Turabian Style

Porto, Roseane Lima Santos, Sonia Oliveira Lima, Cristiane Costa da Cunha Oliveira, Vera Lúcia Corrêa Feitosa, Raissa Pinho Morais, Aline de Siqueira Alves Lopes, Ana Jovina Barreto Bispo, and Francisco Prado Reis. 2026. "COVID-19 in the Neonatal Period in a Reference Maternity for High-Risk Pregnancy: A Hospital-Based Case-Control Study" COVID 6, no. 1: 11. https://doi.org/10.3390/covid6010011

APA Style

Porto, R. L. S., Lima, S. O., da Cunha Oliveira, C. C., Feitosa, V. L. C., Morais, R. P., de Siqueira Alves Lopes, A., Bispo, A. J. B., & Reis, F. P. (2026). COVID-19 in the Neonatal Period in a Reference Maternity for High-Risk Pregnancy: A Hospital-Based Case-Control Study. COVID, 6(1), 11. https://doi.org/10.3390/covid6010011

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