Nasal CPAP and BiPAP as the Initial Respiratory Support in Preterm Infants: A Randomized Controlled Trial

Abstract

Objective

This study aimed to compare the nasal continuous positive airway pressure (nCPAP) and bi-level positive airway pressure (BiPAP) in preterm infants with respiratory distress syndrome (RDS).

Method

Preterm infants (≤32 weeks of gestation) were randomly assigned, at birth, into two study groups: nCPAP or BiPAP. Primary outcomes (surfactant administration and failure of non-invasive respiratory support within the first 72 hours), and secondary outcomes (duration of ventilation support, pneumothorax, bronchopulmonary dysplasia, patent ductus arteriosus, necrotizing enterocolitis, intraventricular haemorrhage, retinopathy of prematurity, time to total enteral feeding, length of hospital stay, and mortality) were assessed.

Results

A total of 188 preterm infants with RDS were analysed. Mean gestational age was 28.8±1.8 weeks (nCPAP) versus 29±1.9 weeks (BiPAP). There were no statistically significant differences between groups in the failure of non-invasive respiratory support (25% vs. 33%, RR: 0.74, 95% CI: 0.47–1.17) or surfactant administration (35% vs. 38%, RR: 0.92, 95% CI: 0.49–1.71). No significant differences were observed in secondary outcomes between the two groups. Subgroup analysis of infants<30 weeks yielded similar results.

Conclusion

Although two-level CPAP theoretically offers benefits, BiPAP was not superior to nCPAP as initial support in preterm infants with RDS. This underscores the continued value of the simpler, well-established nCPAP and the need for multicentre trials involving preterm infants of varying gestational ages.

Zusammenfassung

Ziel

Diese Studie hatte zum Ziel, den nasalen kontinuierlichen positiven Atemwegsdruck (nCPAP) und den bi-level positiven Atemwegsdruck (BiPAP) bei Frühgeborenen mit Atemnotsyndrom (RDS) zu vergleichen.

Methode

Frühgeborene (≤ 32 Schwangerschaftswochen) wurden unmittelbar nach der Geburt zufällig in zwei Studiengruppen eingeteilt: nCPAP oder BiPAP. Als primäre Endpunkte wurden die Verabreichung von Surfactant und das Versagen der nicht-invasiven Atemunterstützung innerhalb der ersten 72 Stunden bewertet, während als sekundäre Endpunkte die Dauer der Beatmungsunterstützung, Pneumothorax, bronchopulmonale Dysplasie, persistierender Ductus arteriosus, nekrotisierende Enterokolitis, intraventrikuläre Blutung, Retinopathie der Frühgeborenen, Zeit bis zur vollständigen enteralen Ernährung, Dauer des Krankenhausaufenthalts und die Mortalität beurteilt wurden.

Ergebnisse

Insgesamt wurden 188 Frühgeborene mit RDS analysiert. Das mittlere Gestationsalter betrug 28,8±1,8 Wochen in der nCPAP-Gruppe und 29±1,9 Wochen in der BiPAP-Gruppe. Es zeigten sich keine statistisch signifikanten Unterschiede zwischen den Gruppen hinsichtlich des Versagens der nicht-invasiven Unterstützung (25% vs. 33%, RR: 0,74, 95% CI: 0,47–1,17) oder der Verabreichung von Surfactant (35% vs. 38%, RR: 0,92, 95% CI: 0,49–1,71). Auch bei den sekundären Endpunkten wurden keine signifikanten Unterschiede festgestellt. Eine Subgruppenanalyse bei Frühgeborenen unter 30 Wochen ergab ähnliche Ergebnisse.

Schlussfolgerung

Obwohl ein bi-level CPAP theoretisch Vorteile bieten könnte, war BiPAP als initiale Unterstützung bei Frühgeborenen mit RDS nicht überlegen gegenüber nCPAP. Dies unterstreicht den fortwährenden Wert des einfacheren, bewährten nCPAP und die Notwendigkeit multizentrischer Studien, die Frühgeborene unterschiedlichen Gestationsalters einbeziehen.

Keywords

Bi-level positive airway pressure - Nasal continuous positive airway pressure - Non-invasive respiratory support - Respiratory distress syndrome - Surfactant

Schlüsselwörter

Bi-Level-positiver Atemwegsdruck - Nasaler kontinuierlicher positiver Atemwegsdruck - Nicht-invasive Atemunterstützung - Atemnotsyndrom - Surfactant

Publication History

Article published online:
06 May 2025

• References

• 1 Shi Y, Muniraman H, Biniwale M. et al. A Review on Noninvasive Respiratory Support for Management of Respiratory Distress in Extremely Preterm Infants. Front Pediatr 2020; 28: 270
• 2 Sweet DG, Carnielli VP, Greisen G. et al. European Consensus Guidelines on the Management of Respiratory Distress Syndrome: 2022 Update. Neonatology 2023; 120: 3-23
• 3 Permall DL, Pasha AB, Chen XQ. Current insights in noninvasive ventilation for the treatment of neonatal respiratory disease. Ital J Pediatr 2019; 45: 105
• 4 Alexiou S, Panitch HB. Physiology of noninvasive respiratory support. Semin Fetal Neonatal Med 2016; 21: 174-180
• 5 Oncel MY, Arayici S, Uras N. et al. Nasal continuous positive airway pressure versus nasal intermittent positive-pressure ventilation within the minimally invasive surfactant therapy approach in preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed 2016; 101: F323-F328
• 6 Fischer HS, Bührer C. Avoiding endotracheal ventilation to prevent bronchopulmonary dysplasia: a meta-analysis. Pediatrics 2013; 132: e1351-e1360
• 7 Nasef N, Rashed HM, Aly H. Practical aspects on the use of noninvasive respiratory support in preterm infants. Int J Pediatr Adolesc Med 2020; 7: 19-25
• 8 Roberts CT, Davis PG, Owen LS. Neonatal noninvasive respiratory support: synchronised NIPPV, non-synchronised NIPPV or bi-level CPAP: what is the evidence in 2013?. Neonatology 2013; 104: 203-209
• 9 Schmölzer GM, Kumar M, Pichler G. et al. Noninvasive versus invasive respiratory support in preterm infants at birth: systematic review and meta-analysis. BMJ 2013; 347: f5980
• 10 Rong ZH, Li WB, Liu W. et al. Nasal bi-level positive airway pressure (BiPAP) versus nasal continuous positive airway pressure (CPAP) in preterm infants ≤32 weeks: A retrospective cohort study. J Paediatr Child Health 2016; 52: 493-498
• 11 Ancora G, Maranella E, Grandi S. et al. Role of bilevel positive airway pressure in the management of preterm newborns who have received surfactant. Acta Paediatr 2010; 99: 1807-1811
• 12 Lista G, Castoldi F, Fontana P. et al. Nasal continuous positive airway pressure (CPAP) versus bi-level nasal CPAP in preterm babies with respiratory distress syndrome: a randomised control trial. Arch Dis Child Fetal Neonatal Ed 2010; 95: F85-F89
• 13 Malakian A, Aramesh MR, Agahin M. et al. Non-invasive duo positive airway pressure ventilation versus nasal continuous positive airway pressure in preterm infants with respiratory distress syndrome: a randomized controlled trial. BMC Pediatr 2021; 21: 301
• 14 Aguiar T, Macedo I, Voutsen O. et al. Nasal bilevel vs continuous positive airway pressure in preterm infants: a randomized controlled trial. J Clin Trials 2015; 5: 221
• 15 Lee MJ, Choi EK, Park KH. et al. Effectiveness of nCPAP for moderate preterm infants compared to BiPAP: A Randomized, Controlled Non-Inferiority Trial. Pediatr Int 2020; 62: 59-64
• 16 Sadeghnia A, Barekateyn B, Badiei Z. et al. Analysis and comparison of the effects of N-BiPAP and Bubble-CPAP in treatment of preterm newborns with the weight of below 1500 grams affiliated with respiratory distress syndrome: A randomised clinical trial. Adv Biomed Res 2016; 27: 3
• 17 Wood FE, Gupta S, Tin W. et al Randomised controlled trial of synchronised intermittent positive airway pressure (SiPAP) versus continuous positive airway pressure (CPAP) as a primary mode of respiratory support in preterm infants with respiratory distress syndrome. Arch Dis Child 2013; 98 A1-117
• 18 Buyuktiryaki M, Okur N, Sari FN. et al. Comparison of three different noninvasive ventilation strategies as initial respiratory support in very low birth weight infants with respiratory distress syndrome: A retrospective study. Arch Pediatr 2020; 27: 322-327
• 19 Salvo V, Lista G, Lupo E. et al. Comparison of three noninvasive ventilation strategies (NSIPPV/BiPAP/NCPAP) for RDS in VLBW infants. J Matern Fetal Neonatal Med 2018; 31: 2832-2838
• 20 Ozkan H, Erdeve O, Kanmaz Kutman G. Turkish Neonatal Society guideline on the management of respiratory distress syndrome and surfactant treatment. Turk Pediatri Ars 2018; 53: 45-54
• 21 Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med 2001; 163: 1723-1729
• 22 Papile LA, Burstein J, Burstein R. et al. Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1500 g. J Pediatr 1978; 92: 529-533
• 23 Bell MJ, Ternberg JL, Feigin RD. et al. Neonatal necrotizing enterocolitis: therapeutic decisions based upon clinical staging. Ann Surg 1978; 187: 1-7
• 24 Section on Ophthalmology American Academy of Pediatrics, American Academy of Ophthalmology, American Association for Pediatric Ophthalmology and Strabismus Screening examination of premature infants for retinopathy of prematurity. Pediatrics 2006; 117: 572-576
• 25 Claure N, Bancalari E. Non-invasive ventilation in premature infants. Arch Dis Child Fetal Neonatal Ed 2015; 100: F2-F3
• 26 Lampland AL, Plumm B, Worwa C. et al. Bi-level CPAP does not improve gas exchange when compared with conventional CPAP for the treatment of neonates recovering from respiratory distress syndrome. Arch Dis Child Fetal Neonatal Ed 2015; 100: F31-F34
• 27 Migliori C, Motta M, Angeli A. et al. Nasal bilevel vs. continuous positive airway pressure in preterm infants. Pediatr Pulmonol 2005; 40: 426-430
• 28 Ramaswamy VV, More K, Roehr CC. et al. Efficacy of noninvasive respiratory support modes for primary respiratory support in preterm neonates with respiratory distress syndrome: Systematic review and network meta-analysis. Pediatr Pulmonol 2020; 55: 2940-2963
• 29 Solevåg AL, Kann IC. N-BiPAP treatment in infants with respiratory distress syndrome: Apopulation study. Early Hum Dev 2015; 91: 577-581