Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
BMC Pediatrics
Published in: BMC Pediatrics 1/2012

Open Access 01-12-2012 | Research article

Infant flow biphasic nasal continuous positive airway pressure (BP- NCPAP) vs. infant flow NCPAP for the facilitation of extubation in infants' ≤ 1,250 grams: a randomized controlled trial

Authors: Karel O'Brien, Craig Campbell, Leanne Brown, Lisa Wenger, Vibhuti Shah

Published in: BMC Pediatrics | Issue 1/2012

Login to get access

Abstract

Background

The use of mechanical ventilation is associated with lung injury in preterm infants and therefore the goal is to avoid or minimize its use. To date there is very little consensus on what is considered the "best non-invasive ventilation mode" to be used post-extubation. The objective of this study was to compare the effectiveness of biphasic nasal continuous positive airway pressure (BP-NCPAP) vs. NCPAP in facilitating sustained extubation in infants ≤ 1,250 grams.

Methods

We performed a randomized controlled trial of BP-NCPAP vs. NCPAP in infants ≤ 1,250 grams extubated for the first time following mechanical ventilation since birth. Infants were extubated using preset criteria or at the discretion of the attending neonatologist. The primary outcome was the incidence of sustained extubation for 7 days. Secondary outcomes included incidence of adverse events and short-term neonatal outcomes.

Results

Sixty-seven infants received BP-NCPAP and 69 NCPAP. Baseline characteristics were similar between groups. The trial was stopped early due to increased use of non-invasive ventilation from birth, falling short of our calculated sample size of 141 infants per group. The incidence of sustained extubation was not statistically different between the BP-NCPAP vs. NCPAP group (67% vs. 58%, P = 0.27). The incidence of adverse events and short-term neonatal outcomes were similar between the two groups (P > 0.05) except for retinopathy of prematurity which was noted to be higher (P = 0.02) in the BP-NCPAP group.

Conclusions

Biphasic NCPAP may be used to assist in weaning from mechanical ventilation. The effectiveness and safety of BP-NCPAP compared to NCPAP needs to be confirmed in a large multi-center trial as our study conclusions are limited by inadequate sample size.

Clinical Trials Registration #

NCT00308789

Source of support

Grant # 06-06, Physicians Services Incorporated Foundation, Toronto, Canada. Summit technologies Inc. provided additional NCPAP systems and an unrestricted educational grant.
Abstract presented at The Society for Pediatric Research Meeting, Baltimore, USA, May 2nd-5th, 2009 and Canadian Paediatric Society Meeting, June 23rd-29th, Ottawa, 2009.
Appendix
Available only for authorised users
Literature
1.
Lemons JA, Bauer CR, Oh W, Korones SB, Papile LA, Stoll BJ, Verter J, Temprosa M, Wright LL, Ehrenkranz RA, Fanaroff AA, Stark A, Carlo W, Tyson JE, Donovan EF, Shankaran S, Stevenson DK: Very low birth weight outcomes of the National Institute of Child health and human development neonatal research network, January 1995 through December 1996. Pediatrics. 2001, 107: E1-10.1542/peds.107.1.e1.CrossRefPubMed
2.
Jones HP, Karuri S, Cronin CM, Ohlsson A, Peliowski A, Synnes A, Lee SK: Canadian Neonatal Network: Actuarial survival of a large Canadian cohort of preterm infants. BMC Pediatr. 2005, 5: 40-10.1186/1471-2431-5-40.CrossRefPubMedPubMedCentral
3.
Horbar JD, Soll RF, Edwards WH: The Vermont Oxford Network: a community of practice. Clin Perinatol. 2010, 37: 29-47. 10.1016/j.clp.2010.01.003.CrossRefPubMed
4.
5.
SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network, Finer NN, Carlo WA, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Donovan EF, Newman NS, Ambalavanan N, Frantz ID, Buchter S, Sánchez PJ, Kennedy KA, Laroia N, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Bhandari V, Watterberg KL, Higgins RD: Early CPAP versus surfactant in extremely preterm infants. N Engl J Med. 2010, 362: 1970-1979.CrossRefPubMedCentral
6.
Coalson JJ, Winter VT, Siler-Khodr T, Yoder BA: Neonatal chronic lung disease in extremely immature baboons. Am J Respir Crit Care Med. 1999, 160: 1333-1346.CrossRefPubMed
7.
Morley CJ, Davis PG: Continuous positive airway pressure: scientific and clinical rationale. Curr Opin Pediatr. 2008, 20: 119-124. 10.1097/MOP.0b013e3282f63953.CrossRefPubMed
8.
Loeliger M, Inder T, Cain S, Ramesh RC, Camm E, Thomson MA, Coalson J, Rees SM: Cerebral outcomes in a preterm baboon model of early versus delayed nasal continuous positive airway pressure. Pediatrics. 2006, 118: 1640-1653. 10.1542/peds.2006-0653.CrossRefPubMed
9.
Schmidt B, Roberts RS, Davis P, Doyle LW, Barrington KJ, Ohlsson A, Solimano A, Tin W: Caffeine for Apnea of Prematurity Trial Group: Caffeine therapy for apnea of prematurity. N Engl J Med. 2006, 354: 2112-2121. 10.1056/NEJMoa054065.CrossRefPubMed
10.
Schmidt B, Roberts RS, Davis P, Doyle LW, Barrington KJ, Ohlsson A, Solimano A, Tin W, Caffeine for Apnea of Prematurity Trial Group: Long-term effects of caffeine therapy for apnea of prematurity. N Engl J Med.
11.
Klausner JF, Lee AY, Hutchison AA: Decreased imposed work with a new nasal continuous positive airway pressure device. Pediatr Pulmonol. 1996, 22: 188-194. 10.1002/(SICI)1099-0496(199609)22:3<188::AID-PPUL8>3.0.CO;2-L.CrossRefPubMed
12.
Courtney SE, Pyon KH, Saslow JG, Arnold GK, Pandit PB, Habib RH: Lung recruitment and breathing pattern during variable versus continuous flow nasal continuous positive airway pressure in premature infants: an evaluation of three devices. Pediatrics. 2001, 107: 304-308. 10.1542/peds.107.2.304.CrossRefPubMed
13.
Pandit PB, Courtney SE, Pyon KH, Saslow JG, Habib RH: Work of breathing during constant- and variable-flow nasal continuous positive airway pressure in preterm neonates. Pediatrics. 2001, 108: 682-685. 10.1542/peds.108.3.682.CrossRefPubMed
14.
Boumecid H, Rakza T, Abazine A, Klosowski S, Matran R, Storme L: Influence of three nasal continuous positive airway pressure devices on breathing pattern in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2007, 92: F298-F300. 10.1136/adc.2006.103762.CrossRefPubMedPubMedCentral
15.
Bell MJ, Ternberg JL, Feigin RD, Keating JP, Marshall R, Barton L, Brotherton T: Neonatal necrotizing enterocolitis. Therapeutic decisions based upon clinical staging. Ann Surg. 1978, 187: 1-7. 10.1097/00000658-197801000-00001.CrossRefPubMedPubMedCentral
16.
Papile LA, Burstein J, Burstein R, Koffler H: Incidence and evaluation of subependymal and intraventricular hemorrhage: a study of infants with birth weight less than 1,500 grams. J Pediatr. 1978, 92: 529-534. 10.1016/S0022-3476(78)80282-0.CrossRefPubMed
17.
International committee for the classification of retinopathy of prematurity: The International classification of retinopathy of prematurity revisited. Arch Ophthalmol. 2005, 123: 991-999.CrossRef
18.
Campbell DM, Shah PS, Shah V, Kelly EN: Nasal continuous positive airway pressure from high flow cannula versus Infant Flow for Preterm infants. J Perinatol. 2006, 26: 546-549. 10.1038/sj.jp.7211561.CrossRefPubMed
19.
Davis PG, Lemyre B, De Paoli AG: Nasal intermittent positive pressure ventilation (NIPPV) versus nasal continuous positive airway pressure (NCPAP) for preterm neonates after extubation. Cochrane Database Syst Rev. 2001, 3: CD003212-PubMed
20.
Moretti C, Giannini L, Fassi C, Gizzi C, Papoff P, Colarizi P: Nasal flow-synchronized intermittent positive pressure ventilation to facilitate weaning in very low-birthweight infants: unmasked randomized controlled trial. Pediatr Int. 2008, 50: 85-91. 10.1111/j.1442-200X.2007.02525.x.CrossRefPubMed
21.
Friedlich P, Lecart C, Posen R, Ramicone E, Chan L, Ramanathan R: A randomized trial of nasopharyngeal-synchronized intermittent mandatory ventilation versus nasopharyngeal continuous positive airway pressure in very low birth weight infants after extubation. J Perinatol. 1999, 19: 413-418. 10.1038/sj.jp.7200205.CrossRefPubMed
22.
Barrington KJ, Bull D, Finer NN: Randomized trial of nasal synchronized intermittent mandatory ventilation compared with continuous positive airway pressure after extubation of very low birth weight infants. Pediatrics. 2001, 107: 638-641. 10.1542/peds.107.4.638.CrossRefPubMed
23.
Khalaf MN, Brodsky N, Hurley J, Bhandari V: A prospective randomized, controlled trial comparing synchronized nasal intermittent positive pressure ventilation versus nasal continuous positive airway pressure as modes of extubation. Pediatrics. 2001, 108: 13-17. 10.1542/peds.108.1.13.CrossRefPubMed
24.
Moretti C, Gizzi C, Papoff P, Lampariello S, Capoferri M, Calcagnini G, Bucci G: Comparing the effects of nasal synchronized intermittent positive pressure ventilation (nSIPPV) and nasal continuous positive airway pressure (nCPAP) after extubation in very low birth weight infants. Early Hum Dev. 1999, 56: 167-177. 10.1016/S0378-3782(99)00046-8.CrossRefPubMed
25.
Owen LS, Morley CJ, Davis PG: Neonatal nasal intermittent positive pressure ventilation: what do we know in 2007?. Arch Dis Child Fetal Neonatal Ed. 2007, 92: F414-F418. 10.1136/adc.2007.117614.CrossRefPubMedPubMedCentral
26.
Greenough A: Respiratory support techniques for prematurely born infants: new advances and perspectives. Acta Paediatr Taiwan. 2001, 42: 201-206.PubMed
27.
Lista G, Castoldui F, Fontana P, Danielle I, Cavigioli F, Rossi S, Mancuso D, Reali R: Nasal continuous airway pressure (CPAP) versus bi-level nasal CPAP in preterm babies with respiratory distress syndrome: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2010, 95: F85-F89. 10.1136/adc.2009.169219.CrossRefPubMed
28.
Shanmugananda K, Rawal J: Nasal trauma due to nasal continuous positive airway pressure in newborns. Arch Dis Child Fetal Neonatal Ed. 2007, 92: F18-10.1136/adc.2006.095034.CrossRefPubMedPubMedCentral
29.
Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB: Nasal CPAP or intubation at birth for very preterm infants. N Engl J Med. 2008, 358: 700-708. 10.1056/NEJMoa072788.CrossRefPubMed
30.
Garland JS, Nelson DB, Rice T, Neu J: Increased risk of gastrointestinal perforations in neonates mechanically ventilated with either face mask or nasal prongs. Pediatrics. 1985, 76: 406-410.PubMed
Metadata
Title
Infant flow biphasic nasal continuous positive airway pressure (BP- NCPAP) vs. infant flow NCPAP for the facilitation of extubation in infants' ≤ 1,250 grams: a randomized controlled trial
Authors
Karel O'Brien
Craig Campbell
Leanne Brown
Lisa Wenger
Vibhuti Shah
Publication date
01-12-2012
Publisher
BioMed Central
Published in
BMC Pediatrics / Issue 1/2012
Electronic ISSN: 1471-2431
DOI
https://doi.org/10.1186/1471-2431-12-43

Other articles of this Issue 1/2012

BMC Pediatrics 1/2012 Go to the issue

Research article

Weight status and gender-related differences in motor skills and in child care - based physical activity in young children

Research article

Detection of group A Streptococcus in tonsils from pediatric patients reveals high rate of asymptomatic streptococcal carriage

Research article

Measuring transcutaneous bilirubin: a comparative analysis of three devices on a multiracial population

Research article

The prevalence and correlates of behavioral risk factors for cardiovascular health among Southern Brazil adolescents: a cross-sectional study

Research article

Prevalence of hepatopathy in type 1 diabetic children

Study protocol

Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial