The Joint Observation in Neonatology and Neurodevelopmental Outcome of Preterm Infants at Six Months Corrected Age: Secondary Outcome Data from a Randomised Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Participants
2.2. Trial Design, Procedure, Data Collection, and Timing
2.3. Intervention and Follow-Up
2.4. Outcome Measures
2.5. Statistical Analysis
3. Results
3.1. Population
3.2. Baseline Characteristics
3.3. Six-Month Infant Developmental Outcome
4. Discussion
Perspectives
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Intervention Group (N = 33) | Control Group (N = 32) | p-Value | |
---|---|---|---|
Pregnancy variables | |||
Maternal age (M, IQR) | 32 (30–34.5) | 32.5 (30–36.8) | p = 0.381 U = 461.5 |
Number of pregnancies (M, IQR) | 1 (1–2) | 1 (1–2) | p = 0.810 U = 512 |
Maternal Largo score (M, IQR) missing n = 1 | 2 (2–3.8) | 2 (1–3) | p = 0.319 U = 441 |
Paternal Largo score (M, IQR) missing n = 7 | 3 (2–4) | 3 (1.5–3) | p = 0.802 U = 405 |
Multiple pregnancy (N, %) | 9 (27.3) | 5 (15.6) | 0.367 |
Assisted reproduction (N, %) | 4 (12.1) | 3 (9.4) | 1 |
Prenatal steroids (N, %) | 26 (78.8) | 29 (90.6) | 0.303 |
Neonatal variables | |||
Female (N, %) | 21 (63.6) | 16 (50) | 0.321 |
Gestational age, weeks (M, IQR) | 30.1 (28.7–31.4) | 30.2 (29.6–31.4) | p = 0.412 U = 465.5 |
Birth weight, grams (M, IQR) | 1240 (990–1456.5) | 1237.5 (1006–1523.8) | p = 0.896 U = 518 |
Small for gestational age (N, %) | 5 (15.2) | 7 (21.9) | 0.562 |
Head circumference at birth, centimeters (M, IQR) | 26.5 (25–28.3) | 27 (25.6–28.5) | p = 0.429 U = 468 |
Inborn (N, %) | 31 (93.9) | 29 (90.6) | 0.672 |
Arterial cord pH (M, IQR) missing n = 18 | 7.3 (7.2–7.3) | 7.3 (7.2–7.3) | p = 0.676 U = 253.5 |
Apgar 5 min (M, IQR) | 9 (8–10) | 9 (8–9) | p = 0.325 U = 456 |
CRIB score (M, IQR) | 6 (3.5–7) | 5 (3–6.8) | p = 0.500 U = 477 |
Mechanical ventilation, hours (M, IQR) | 0 (0–13) | 0 (0–9.5) | p = 0.510 U = 484.5 |
Noninvasive ventilation, hours (M, IQR) missing n = 1 | 658.5 (229.5–919.8) | 304.5 (65.3–789.8) | p = 0.093 U = 387 |
Moderate and severe BPD – bronchopulmonary dysplasia (N, %) | 2 (6.1) | 3 (9.4) | p = 0.443 |
Postnatal steroids (N, %) | 2 (6.1) | 2 (6.3) | 1 |
Persistent ductus arteriosus (PDA) (N. %) | 33 (100) | 32 (100) | 0.303 |
- medical treatment | 3 (9.1) | 6 (18.8) | |
- surgical ligature | 0 (100) | 0 (100) | |
Other surgery (N, %) | 1 (3) | 3 (9.4) | 0.355 |
Early onset sepsis (EOS) (N, %) | 1 (3) | 2 (6.3) | 0.613 |
Late onset sepsis (LOS) (N, %) | 7 (21.2) | 6 (18.8) | 1 |
Necrotizing enterocolitis (NEC) (N, %) | 1 (3) | 0 (0) | 1 |
Intraventricular hemorrhage (IVH) (N, %) | 0.514 | ||
- grade 1 | 4 (12.1) | 7 (21.9) | |
- grade 2 | 1 (3) | 1 (3.1) | |
- grade 3 | 0 (0) | 1 (3.1) | |
- grade 4 | 0 (0) | 0 (0) | |
Periventricular leukomalacia (PVL) (N, %) | 33 (100) | 32 (100) | 0.513 |
- grade 1 | 1 (3) | 2 (6.3) | |
- grade 2 | 1 (3) | 0 (0) | |
- grade 3 | 0 (0) | 0 (0) | |
- grade 4 | 0 (0) | 0 (0) | |
Retinopathy of prematurity (ROP) (N, %) | 1 (3) | 0 (0) | 1 |
Abnormal hearing test (N, %) | 1 (3) | 1 (3.1) | 1 |
Length of stay in level III hospital, days (M, IQR) | 49 (36 – 62) | 37 (21 – 56) | p = 0.198 U = 430 |
Issue (N, %) | 33 (100) | 32 (100) | 0.136 |
death | 0 (0) | 0 (0) | |
transfer to another unit/hospital | 15 (45.5) | 21 (65.6) | |
discharge home | 18 (54.5) | 11 (34.4) |
Intervention group (N = 33) | Control group (N = 32) | p-value | |
---|---|---|---|
Six-month CA assessment variables | |||
Chronological age, months (M, IQR) | 9 (8–9) | 8 (8–9) | p = 0.346 U = 461.5 |
Corrected age, months (M, IQR) | 6 (6–7) | 6 (6–7) | p = 0.447 U = 476.5 |
Hospitalization after NICU discharge (N, %) | 7 (21.2) | 8 (25) | 0.775 |
Relevant medical condition (N, %) | 7 (21.2) | 7 (21.9) | 1 |
Physiotherapy (N, %) | 15 (45.5) | 10 (31.3) | 0.310 |
Daycare attendance (N, %) missing n = 2 | 4 (12.1) | 3 (10) | 0.646 |
Maternal return to work (N, %) missing n = 3 | 23 (69.7) | 18 (62.1) | 0.596 |
Siblings (N, %) missing n = 1 | 13 (40.6) | 13 (40.6) | 1 |
Sleep disorder (N, %) | 0 (0) | 2 (6.3) | 0.238 |
Acquisition of the sitting position (N, %) | 27 (81.8) | 29 (90.6) | 0.475 |
Acquisition of moving on 4 points (N. %) | 12 (36.4) | 12 (37.5) | 1 |
Weight at 6 months, grams (M, IQR) | 7400 (6600–8020) | 7175 (6362.5–8462.5) | p = 1 U = 528 |
Length at 6 months, centimeters (M, IQR) | 68 (65–69) | 67 (64–69.8) | p = 0.721 U = 501 |
Head circumference at 6 months, centimeters (M, IQR) | 43.2 (42–44.2) | 44 (42.8–44.5) | p = 0.076 U = 393 |
Neurological exam variables | |||
Tone disorder (N, %) | 4 (12.1) | 6 (18.8) | 0.511 |
Visual impairment (N, %) | 2 (6.1) | 2 (6.3) | 1 |
- strabismus | 1 (3) | 1 (3.1) | |
- retinal immaturity | 0 (0) | 1 (3.1) | |
- retinal detachment and retinopathy of prematurity | 1 (3) | 0 (0) | |
Hearing impairment: abnormal auditory evoked potentials (N, %) | 1 (3) | 0 (0) | 1 |
Standardised developmental tests | |||
Bayley—cognition scale (M, IQR) | 110 (105–115) n = 20 | 115 (106.3–115) n = 16 | p = 0.102 U = 110.5 |
Bayley—language scale (M, IQR) | 94 (91–100) n = 20 | 97 (91.8–102.3) n = 16 | p = 0.479 U =138 |
Bayley—motor scale (M, IQR) | 97 (85–106) n = 20 | 100 (91.8–111.5) n = 16 | p = 0.315 U = 128.5 |
Griffiths—developmental quotient (M, IQR) | 99 (96.3–110.8) n = 12 | 100 (92–103) n = 15 | p = 0.591 U = 79 |
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Lovey, O.; Bickle-Graz, M.; Morisod Harari, M.; Horsch, A.; Schneider, J., on behalf of the JOIN Research Consortium. The Joint Observation in Neonatology and Neurodevelopmental Outcome of Preterm Infants at Six Months Corrected Age: Secondary Outcome Data from a Randomised Controlled Trial. Children 2022, 9, 1380. https://doi.org/10.3390/children9091380
Lovey O, Bickle-Graz M, Morisod Harari M, Horsch A, Schneider J on behalf of the JOIN Research Consortium. The Joint Observation in Neonatology and Neurodevelopmental Outcome of Preterm Infants at Six Months Corrected Age: Secondary Outcome Data from a Randomised Controlled Trial. Children. 2022; 9(9):1380. https://doi.org/10.3390/children9091380
Chicago/Turabian StyleLovey, Oriane, Myriam Bickle-Graz, Mathilde Morisod Harari, Antje Horsch, and Juliane Schneider on behalf of the JOIN Research Consortium. 2022. "The Joint Observation in Neonatology and Neurodevelopmental Outcome of Preterm Infants at Six Months Corrected Age: Secondary Outcome Data from a Randomised Controlled Trial" Children 9, no. 9: 1380. https://doi.org/10.3390/children9091380