Lactoferrin in the Prevention of Recurrent Respiratory Infections in Preschool Children: A Prospective Randomized Study
Abstract
:1. Introduction
2. Methods
2.1. Study Design
2.2. Patients
2.3. Calculation of Sample Size
2.4. Treatment
2.5. Outcome Measures
2.6. Statistical Analysis
3. Results
3.1. Patient Characteristics
3.2. Effect of bLf on Frequency of Respiratory Infections
3.3. Secondary Outcome Measures and Follow Up
4. Discussion
5. Study Limitations
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Whole Group (n = 50) | Control Group (n = 25) | Active Group (n = 25) | p-Value | |
---|---|---|---|---|
Age (years) | 4.2 ± 0.1 | 4.4 ± 0.2 | 4.0 ± 0.2 | 0.14 |
Male gender, n (%) | 32 (64) | 14 (56) | 18 (72) | 0.24 |
Number of families with at least one member who smokes, n (%) | 14 (28) | 7 (28) | 7 (28) | 1.00 |
Number of family members, n | 4 (3–4) | 4 (3–4) | 4 (3–4) | 0.17 |
Symptoms | ||||
respiratory, n (%) | 39 (78) | 20 (80) | 19 (76) | 0.73 |
fever, n (%) | 7 (14) | 5 (20) | 2 (8) | 0.22 |
cough, n (%) | 32 (64) | 16(64) | 16(64) | 1.00 |
sore throat, n (%) | 15 (30) | 8(32) | 7(28) | 0.76 |
ear pain, n (%) | 4 (8) | 3(12) | 2(4) | 0.30 |
nasal congestion n (%) | 26 (52) | 12 (48) | 14 (56) | 0.57 |
runny nose, n (%) | 18 (36) | 10 (40) | 8 (32) | 0.56 |
bronchospasm, n (%) | 3 (6) | 1 (4) | 2 (8) | 0.55 |
Treatment | ||||
antibiotic, n (%) | 9 (18) | 4 (16) | 5 (20) | 0.71 |
anti-pyretic, n (%) | 16 (32) | 9 (36) | 7 (28) | 0.54 |
mucolytic, n (%) | 3 (6) | 2 (8) | 1 (4) | 0.55 |
corticosteroids (aerosol), n (%) | 16 (32) | 7(28) | 9 (36) | 0.54 |
Oral corticosteroids, n (%) | 6 (12) | 4(16) | 2(8) | 0.38 |
bronchodilators n (%) | 5 (10) | 2 (8) | 3 (12) | 0.64 |
Duration of symptoms (days) | 4 (2–6) | 4 (3–7) | 4 (1–5) | 0.29 |
Number of days of absence from school | 3 (0–5) | 3 (2–5) | 1 (0–5) | 0.37 |
Control Group (n = 25) | Active Group (n = 25) | p-Value | |
---|---|---|---|
4-month period (active phase) | |||
Episodes of respiratory infections (n) | 2 (1–3) | 1 (0–2) | 0.02 |
Duration of symptoms (days) | 6 (5–9) | 3 (0–6) | 0.01 |
Absence from school (days) | 6 (2–8) | 3 (0–7) | 0.15 |
2-month period (follow-up) | |||
Episodes of respiratory infections (n) | 0 (0–1) | 1 (0–1) | 0.23 |
Duration of symptoms (days) | 0 (0–4) | 0 (0–3) | 0.84 |
Absence from school (days) | 0 (0–4) | 0 (0–0) | 0.60 |
Total period | |||
Treated with antibiotics, n (%) | 9 (36) | 12 (48) | 0.39 |
Treated with cortisone, n (%) | 15 (60) | 8 (32) | 0.047 |
Patients with fever, n (%) | 16 (64) | 12 (48) | 0.25 |
Patients with COVID, n (%) | 2 (8) | 1 (4) | 1.00 |
Patients with flu vaccine, n (%) | 9 (36) | 9 (36) | 1.00 |
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Pasinato, A.; Fama, M.; Tripepi, G.; Egan, C.G.; Baraldi, E., on behalf of the LIRAR Study Group. Lactoferrin in the Prevention of Recurrent Respiratory Infections in Preschool Children: A Prospective Randomized Study. Children 2024, 11, 249. https://doi.org/10.3390/children11020249
Pasinato A, Fama M, Tripepi G, Egan CG, Baraldi E on behalf of the LIRAR Study Group. Lactoferrin in the Prevention of Recurrent Respiratory Infections in Preschool Children: A Prospective Randomized Study. Children. 2024; 11(2):249. https://doi.org/10.3390/children11020249
Chicago/Turabian StylePasinato, Angela, Mario Fama, Giovanni Tripepi, Colin Gerard Egan, and Eugenio Baraldi on behalf of the LIRAR Study Group. 2024. "Lactoferrin in the Prevention of Recurrent Respiratory Infections in Preschool Children: A Prospective Randomized Study" Children 11, no. 2: 249. https://doi.org/10.3390/children11020249