Early surfactant for neonates with mild to moderate respiratory distress syndrome: a multicenter, randomized trial

Early surfactant for neonates with mild to moderate respiratory distress syndrome: a multicenter, randomized trial

We studied the efficacy and safety of electively providing surfactant to preterm infants with mild to moderate respiratory distress syndrome (RDS) not requiring mechanical ventilation. A 5-center, randomized clinical trial was performed on 132 infants with RDS, birth weight ≥1250 grams, gestational...

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Published in:The Journal of pediatrics Vol. 144; no. 6; pp. 804 - 808
Main Authors: Escobedo, Marilyn B, Gunkel, John Harry, Kennedy, Kathleen A, Shattuck, Karen E, Sánchez, Pablo J, Seidner, Steven, Hensley, Gaynelle, Cochran, Candace K, Moya, Fernando, Morris, Brenda, Denson, Susan, Stribley, Richard, Naqvi, Mubariz, Lasky, Robert E
Format: Journal Article
Language:English
Published: New York, NY Mosby, Inc 01-06-2004
Elsevier
Subjects:
Biological and medical sciences
Female
General aspects
Humans
Infant, Newborn
Infant, Premature
Male
Medical sciences
Pneumology
Pulmonary Surfactants - therapeutic use
Respiration, Artificial
Respiratory Distress Syndrome, Newborn - drug therapy
Respiratory system : syndromes and miscellaneous diseases
NCPAP
RDS
CPAP
Human
Pediatrics
Newborn
Pulmonary surfactant
Respiratory disease
Respiratory distress
Clinical trial
Early
Surfactant
Syndrome
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Summary:We studied the efficacy and safety of electively providing surfactant to preterm infants with mild to moderate respiratory distress syndrome (RDS) not requiring mechanical ventilation. A 5-center, randomized clinical trial was performed on 132 infants with RDS, birth weight ≥1250 grams, gestational age ≤36 weeks, postnatal age 4 to 24 hours, Fio2 ≥40% for ≥1 hour, and no immediate need for intubation. Infants were randomly assigned to intubation, surfactant (Survanta, Ross Laboratories, Columbus, Ohio) administration, and expedited extubation (n=65) or expectant management (n=67) with subsequent intubation and surfactant treatment as clinically indicated. The primary outcome was duration of mechanical ventilation. Infants in the surfactant group had a median duration of mechanical ventilation of 2.2 hours compared with 0.0 hours for control infants, since only 29 of 67 control infants required mechanical ventilation (P=.001). Surfactant-treated infants were less likely to require subsequent mechanical ventilation for worsening respiratory disease (26% vs 43%, relative risk=0.60; 95% CI, 0.37, 0.99). There were no differences in secondary outcomes (duration of nasal continuous positive airway pressure, oxygen therapy, hospital stay, or adverse outcomes). Routine elective intubation for administration of surfactant to preterm infants ≥1250 grams with mild to moderate RDS is not recommended.
Bibliography:ObjectType-Article-2
SourceType-Scholarly Journals-1
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ISSN:0022-3476
1097-6833
DOI:10.1016/j.jpeds.2004.03.024