A Phase 3 interventional study of Early surfactant and Standard practice in Infant, Newborn, Respiratory Distress Syndrome and Respiratory Insufficiency, sponsored by NICHD Neonatal Research Network. Terminated at 13 sites in United States. Open to participants aged Up to 12 Hours. Per ClinicalTrials.gov, last updated 2015-06-08.
Sponsored by NICHD Neonatal Research Network · Phase 3, Interventional, and Treatment
Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.
Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. The role of surfactant therapy in the management of larger infants with respiratory distress syndrome (RDS) was unclear. In many neonatal intensive care units, these infants were routinely managed with continuous positive airway pressure (CPAP) alone.
This trial tested whether early use of surfactant combined with CPAP would ameliorate the course of RDS without an increased risk of death. Primary study outcomes were measures of use of mechanical ventilation, and thereby likely reduction in risk of ventilator-associated morbidity.
Eligible infants were randomized before the infant is 12 hours of age to receive either: early surfactant followed by extubation within 30 minutes and application of CPAP (intervention group); or surfactant according to current center practice, only after initiation of mechanical ventilation (control group).
The trial was stopped after 7 months for lack of recruitment.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 61 is close to the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →NICHD Neonatal Research Network is the lead sponsor of 63 studies on the registry; 5 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
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Exclusion Criteria:
Drug: Early surfactant
Drug: Standard practice
Early surfactant followed by extubation within 30 minutes and application of continuous positive airway pressure (CPAP)
Also known as: Survanta
Surfactant according to current center practice, only after initiation of mechanical ventilation.
Need for mechanical ventilation following randomization
Time frame: Until hospital discharge or 120 days of life
Mean duration of mechanical ventilation
Time frame: Until hospital discharge or 120 days of life
Risk morbidities associated with mechanical ventilation and/or early surfactant administration
Time frame: Until hospital discharge or 120 days of life
This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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NICHD Neonatal Research Network