At a glance

ClinicalIndex Comparison Record

Phase 3Terminated· 61 enrolled

Drug / intervention

Early surfactant +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00005774

NCT00005774Phase 3Terminated

Terminated

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Early Surfactant Followed by Nasal CPAP to Reduce the Use of Mechanical Ventilation Without Additional Morbidity in Infants 1250- 2000 Grams With RDS

NICHD Neonatal Research Network·interventional·Posted Jun 2, 2000·Updated Jun 8, 2015

In Brief

A Phase 3 clinical trial evaluating Early surfactant and Standard practice for Infant, Newborn and 2 related conditions. Terminated early, enrolled 61 participants across 13 sites.

Signals

Trial was terminated early

Detailed Summary

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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfant, Newborn, Respiratory Distress Syndrome, Respiratory Insufficiency

CountriesUnited States

CollaboratorsNational Center for Research Resources (NCRR)

Timeline

Phase 3TerminatedFinished

2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMay 2000

First PostedJun 2000

Primary CompletionJul 2002

TodayJul 2026

First PostedJun 2, 2000

Enrollment StartMay 1, 2000

Primary CompletionJul 1, 2002

TodayJul 1, 2026

Enrollment to primary: 2.2 yearsPosted 26.1 years ago

Interventions

Early surfactantdrug

Early surfactant followed by extubation within 30 minutes and application of continuous positive airway pressure (CPAP)

Standard practicedrug

Surfactant according to current center practice, only after initiation of mechanical ventilation.