Abstract | BACKGROUND: METHODS: We randomly assigned 610 infants who were born at 25-to-28-weeks' gestation to CPAP or intubation and ventilation at 5 minutes after birth. We assessed outcomes at 28 days of age, at 36 weeks' gestational age, and before discharge. RESULTS: At 36 weeks' gestational age, 33.9% of 307 infants who were assigned to receive CPAP had died or had bronchopulmonary dysplasia, as compared with 38.9% of 303 infants who were assigned to receive intubation (odds ratio favoring CPAP, 0.80; 95% confidence interval [CI], 0.58 to 1.12; P=0.19). At 28 days, there was a lower risk of death or need for oxygen therapy in the CPAP group than in the intubation group (odds ratio, 0.63; 95% CI, 0.46 to 0.88; P=0.006). There was little difference in overall mortality. In the CPAP group, 46% of infants were intubated during the first 5 days, and the use of surfactant was halved. The incidence of pneumothorax was 9% in the CPAP group, as compared with 3% in the intubation group (P<0.001). There were no other serious adverse events. The CPAP group had fewer days of ventilation. CONCLUSIONS: In infants born at 25-to-28-weeks' gestation, early nasal CPAP did not significantly reduce the rate of death or bronchopulmonary dysplasia, as compared with intubation. Even though the CPAP group had more incidences of pneumothorax, fewer infants received oxygen at 28 days, and they had fewer days of ventilation. (Australian New Zealand Clinical Trials Registry number, 12606000258550.).
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Authors | Colin J Morley, Peter G Davis, Lex W Doyle, Luc P Brion, Jean-Michel Hascoet, John B Carlin, COIN Trial Investigators |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 358
Issue 7
Pg. 700-8
(Feb 14 2008)
ISSN: 1533-4406 [Electronic] United States |
PMID | 18272893
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright 2008 Massachusetts Medical Society. |
Chemical References |
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Topics |
- Bronchopulmonary Dysplasia
(epidemiology, prevention & control)
- Continuous Positive Airway Pressure
(adverse effects)
- Female
- Gestational Age
- Humans
- Infant Mortality
- Infant, Newborn
- Infant, Premature
- Intubation, Intratracheal
- Logistic Models
- Male
- Odds Ratio
- Oxygen Inhalation Therapy
(statistics & numerical data)
- Pneumothorax
(epidemiology, etiology)
- Pulmonary Surfactants
(therapeutic use)
- Respiration, Artificial
- Respiratory Distress Syndrome, Newborn
(drug therapy, mortality, therapy)
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