Early CPAP versus surfactant in extremely preterm infants

Neil N. Finer, Waldemar A. Carlo, Michele C. Walsh, Wade Rich, Marie G. Gantz, Abbot R. Laptook, Bradley A. Yoder, Roger G. Faix, Abhik Das, W. Kenneth Poole, Edward F. Donovan, Nancy S. Newman, Namasivayam Ambalavanan, Ivan D. Frantz, Susie Buchter, Pablo J. Sánchez, Kathleen A. Kennedy, Nirupama Laroia, Brenda B. Poindexter, C. Michael Cotten & 9 others Krisa P. Van Meurs, Shahnaz Duara, Vivek Narendran, Beena G. Sood, T. Michael O'Shea, Edward F. Bell, Vineet Bhandari, Kristi L. Watterberg, Rosemary D. Higgins

Research output: Contribution to journalArticle

627 Citations (Scopus)

Abstract

BACKGROUND: There are limited data to inform the choice between early treatment with continuous positive airway pressure (CPAP) and early surfactant treatment as the initial support for extremely-low-birth-weight infants. METHODS: We performed a randomized, multicenter trial, with a 2-by-2 factorial design, involving infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. Infants were randomly assigned to intubation and surfactant treatment (within 1 hour after birth) or to CPAP treatment initiated in the delivery room, with subsequent use of a protocol-driven limited ventilation strategy. Infants were also randomly assigned to one of two target ranges of oxygen saturation. The primary outcome was death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen at 36 weeks (with an attempt at withdrawal of supplemental oxygen in neonates who were receiving less than 30% oxygen). RESULTS: A total of 1316 infants were enrolled in the study. The rates of the primary outcome did not differ significantly between the CPAP group and the surfactant group (47.8% and 51.0%, respectively; relative risk with CPAP, 0.95; 95% confidence interval [CI], 0.85 to 1.05) after adjustment for gestational age, center, and familial clustering. The results were similar when bronchopulmonary dysplasia was defined according to the need for any supplemental oxygen at 36 weeks (rates of primary outcome, 48.7% and 54.1%, respectively; relative risk with CPAP, 0.91; 95% CI, 0.83 to 1.01). Infants who received CPAP treatment, as compared with infants who received surfactant treatment, less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia (P<0.001), required fewer days of mechanical ventilation (P=0.03), and were more likely to be alive and free from the need for mechanical ventilation by day 7 (P=0.01). The rates of other adverse neonatal outcomes did not differ significantly between the two groups. CONCLUSIONS: The results of this study support consideration of CPAP as an alternative to intubation and surfactant in preterm infants. (ClinicalTrials.gov number, NCT00233324.)

Original languageEnglish (US)
Pages (from-to)1970-1979
Number of pages10
JournalNew England Journal of Medicine
Volume362
Issue number21
DOIs
StatePublished - May 27 2010

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Extremely Premature Infants
Continuous Positive Airway Pressure
Surface-Active Agents
Bronchopulmonary Dysplasia
Oxygen
Intubation
Artificial Respiration
Therapeutics
Extremely Low Birth Weight Infant
Confidence Intervals
Delivery Rooms
Premature Infants
Gestational Age
Multicenter Studies
Cluster Analysis
Ventilation
Adrenal Cortex Hormones
Parturition
Newborn Infant
Pregnancy

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Finer, N. N., Carlo, W. A., Walsh, M. C., Rich, W., Gantz, M. G., Laptook, A. R., ... Higgins, R. D. (2010). Early CPAP versus surfactant in extremely preterm infants. New England Journal of Medicine, 362(21), 1970-1979. https://doi.org/10.1056/NEJMoa0911783

Early CPAP versus surfactant in extremely preterm infants. / Finer, Neil N.; Carlo, Waldemar A.; Walsh, Michele C.; Rich, Wade; Gantz, Marie G.; Laptook, Abbot R.; Yoder, Bradley A.; Faix, Roger G.; Das, Abhik; Poole, W. Kenneth; Donovan, Edward F.; Newman, Nancy S.; Ambalavanan, Namasivayam; Frantz, Ivan D.; Buchter, Susie; Sánchez, Pablo J.; Kennedy, Kathleen A.; Laroia, Nirupama; Poindexter, Brenda B.; Cotten, C. Michael; Van Meurs, Krisa P.; Duara, Shahnaz; Narendran, Vivek; Sood, Beena G.; O'Shea, T. Michael; Bell, Edward F.; Bhandari, Vineet; Watterberg, Kristi L.; Higgins, Rosemary D.

In: New England Journal of Medicine, Vol. 362, No. 21, 27.05.2010, p. 1970-1979.

Research output: Contribution to journalArticle

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 2010, 'Early CPAP versus surfactant in extremely preterm infants', New England Journal of Medicine, vol. 362, no. 21, pp. 1970-1979. https://doi.org/10.1056/NEJMoa0911783
Finer NN, Carlo WA, Walsh MC, Rich W, Gantz MG, Laptook AR et al. Early CPAP versus surfactant in extremely preterm infants. New England Journal of Medicine. 2010 May 27;362(21):1970-1979. https://doi.org/10.1056/NEJMoa0911783
Finer, Neil N. ; Carlo, Waldemar A. ; Walsh, Michele C. ; Rich, Wade ; Gantz, Marie G. ; Laptook, Abbot R. ; Yoder, Bradley A. ; Faix, Roger G. ; Das, Abhik ; Poole, W. Kenneth ; Donovan, Edward F. ; Newman, Nancy S. ; Ambalavanan, Namasivayam ; Frantz, Ivan D. ; Buchter, Susie ; Sánchez, Pablo J. ; Kennedy, Kathleen A. ; Laroia, Nirupama ; Poindexter, Brenda B. ; Cotten, C. Michael ; Van Meurs, Krisa P. ; Duara, Shahnaz ; Narendran, Vivek ; Sood, Beena G. ; O'Shea, T. Michael ; Bell, Edward F. ; Bhandari, Vineet ; Watterberg, Kristi L. ; Higgins, Rosemary D. / Early CPAP versus surfactant in extremely preterm infants. In: New England Journal of Medicine. 2010 ; Vol. 362, No. 21. pp. 1970-1979.
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abstract = "BACKGROUND: There are limited data to inform the choice between early treatment with continuous positive airway pressure (CPAP) and early surfactant treatment as the initial support for extremely-low-birth-weight infants. METHODS: We performed a randomized, multicenter trial, with a 2-by-2 factorial design, involving infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. Infants were randomly assigned to intubation and surfactant treatment (within 1 hour after birth) or to CPAP treatment initiated in the delivery room, with subsequent use of a protocol-driven limited ventilation strategy. Infants were also randomly assigned to one of two target ranges of oxygen saturation. The primary outcome was death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen at 36 weeks (with an attempt at withdrawal of supplemental oxygen in neonates who were receiving less than 30{\%} oxygen). RESULTS: A total of 1316 infants were enrolled in the study. The rates of the primary outcome did not differ significantly between the CPAP group and the surfactant group (47.8{\%} and 51.0{\%}, respectively; relative risk with CPAP, 0.95; 95{\%} confidence interval [CI], 0.85 to 1.05) after adjustment for gestational age, center, and familial clustering. The results were similar when bronchopulmonary dysplasia was defined according to the need for any supplemental oxygen at 36 weeks (rates of primary outcome, 48.7{\%} and 54.1{\%}, respectively; relative risk with CPAP, 0.91; 95{\%} CI, 0.83 to 1.01). Infants who received CPAP treatment, as compared with infants who received surfactant treatment, less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia (P<0.001), required fewer days of mechanical ventilation (P=0.03), and were more likely to be alive and free from the need for mechanical ventilation by day 7 (P=0.01). The rates of other adverse neonatal outcomes did not differ significantly between the two groups. CONCLUSIONS: The results of this study support consideration of CPAP as an alternative to intubation and surfactant in preterm infants. (ClinicalTrials.gov number, NCT00233324.)",
author = "Finer, {Neil N.} and Carlo, {Waldemar A.} and Walsh, {Michele C.} and Wade Rich and Gantz, {Marie G.} and Laptook, {Abbot R.} and Yoder, {Bradley A.} and Faix, {Roger G.} and Abhik Das and Poole, {W. Kenneth} and Donovan, {Edward F.} and Newman, {Nancy S.} and Namasivayam Ambalavanan and Frantz, {Ivan D.} and Susie Buchter and S{\'a}nchez, {Pablo J.} and Kennedy, {Kathleen A.} and Nirupama Laroia and Poindexter, {Brenda B.} and Cotten, {C. Michael} and {Van Meurs}, {Krisa P.} and Shahnaz Duara and Vivek Narendran and Sood, {Beena G.} and O'Shea, {T. Michael} and Bell, {Edward F.} and Vineet Bhandari and Watterberg, {Kristi L.} and Higgins, {Rosemary D.}",
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T1 - Early CPAP versus surfactant in extremely preterm infants

AU - Finer, Neil N.

AU - Carlo, Waldemar A.

AU - Walsh, Michele C.

AU - Rich, Wade

AU - Gantz, Marie G.

AU - Laptook, Abbot R.

AU - Yoder, Bradley A.

AU - Faix, Roger G.

AU - Das, Abhik

AU - Poole, W. Kenneth

AU - Donovan, Edward F.

AU - Newman, Nancy S.

AU - Ambalavanan, Namasivayam

AU - Frantz, Ivan D.

AU - Buchter, Susie

AU - Sánchez, Pablo J.

AU - Kennedy, Kathleen A.

AU - Laroia, Nirupama

AU - Poindexter, Brenda B.

AU - Cotten, C. Michael

AU - Van Meurs, Krisa P.

AU - Duara, Shahnaz

AU - Narendran, Vivek

AU - Sood, Beena G.

AU - O'Shea, T. Michael

AU - Bell, Edward F.

AU - Bhandari, Vineet

AU - Watterberg, Kristi L.

AU - Higgins, Rosemary D.

PY - 2010/5/27

Y1 - 2010/5/27

N2 - BACKGROUND: There are limited data to inform the choice between early treatment with continuous positive airway pressure (CPAP) and early surfactant treatment as the initial support for extremely-low-birth-weight infants. METHODS: We performed a randomized, multicenter trial, with a 2-by-2 factorial design, involving infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. Infants were randomly assigned to intubation and surfactant treatment (within 1 hour after birth) or to CPAP treatment initiated in the delivery room, with subsequent use of a protocol-driven limited ventilation strategy. Infants were also randomly assigned to one of two target ranges of oxygen saturation. The primary outcome was death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen at 36 weeks (with an attempt at withdrawal of supplemental oxygen in neonates who were receiving less than 30% oxygen). RESULTS: A total of 1316 infants were enrolled in the study. The rates of the primary outcome did not differ significantly between the CPAP group and the surfactant group (47.8% and 51.0%, respectively; relative risk with CPAP, 0.95; 95% confidence interval [CI], 0.85 to 1.05) after adjustment for gestational age, center, and familial clustering. The results were similar when bronchopulmonary dysplasia was defined according to the need for any supplemental oxygen at 36 weeks (rates of primary outcome, 48.7% and 54.1%, respectively; relative risk with CPAP, 0.91; 95% CI, 0.83 to 1.01). Infants who received CPAP treatment, as compared with infants who received surfactant treatment, less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia (P<0.001), required fewer days of mechanical ventilation (P=0.03), and were more likely to be alive and free from the need for mechanical ventilation by day 7 (P=0.01). The rates of other adverse neonatal outcomes did not differ significantly between the two groups. CONCLUSIONS: The results of this study support consideration of CPAP as an alternative to intubation and surfactant in preterm infants. (ClinicalTrials.gov number, NCT00233324.)

AB - BACKGROUND: There are limited data to inform the choice between early treatment with continuous positive airway pressure (CPAP) and early surfactant treatment as the initial support for extremely-low-birth-weight infants. METHODS: We performed a randomized, multicenter trial, with a 2-by-2 factorial design, involving infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. Infants were randomly assigned to intubation and surfactant treatment (within 1 hour after birth) or to CPAP treatment initiated in the delivery room, with subsequent use of a protocol-driven limited ventilation strategy. Infants were also randomly assigned to one of two target ranges of oxygen saturation. The primary outcome was death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen at 36 weeks (with an attempt at withdrawal of supplemental oxygen in neonates who were receiving less than 30% oxygen). RESULTS: A total of 1316 infants were enrolled in the study. The rates of the primary outcome did not differ significantly between the CPAP group and the surfactant group (47.8% and 51.0%, respectively; relative risk with CPAP, 0.95; 95% confidence interval [CI], 0.85 to 1.05) after adjustment for gestational age, center, and familial clustering. The results were similar when bronchopulmonary dysplasia was defined according to the need for any supplemental oxygen at 36 weeks (rates of primary outcome, 48.7% and 54.1%, respectively; relative risk with CPAP, 0.91; 95% CI, 0.83 to 1.01). Infants who received CPAP treatment, as compared with infants who received surfactant treatment, less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia (P<0.001), required fewer days of mechanical ventilation (P=0.03), and were more likely to be alive and free from the need for mechanical ventilation by day 7 (P=0.01). The rates of other adverse neonatal outcomes did not differ significantly between the two groups. CONCLUSIONS: The results of this study support consideration of CPAP as an alternative to intubation and surfactant in preterm infants. (ClinicalTrials.gov number, NCT00233324.)

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