At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 104 enrolled

Drug / intervention

CPAP/PEEP +1 moredevice

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/NCT01223274

NCT01223274Phase 2Completed

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Delivery Room Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) in Extremely Low Birth Weight (ELBW) Infants

NICHD Neonatal Research Network·interventional·Posted Oct 18, 2010·Updated Sep 26, 2017

In Brief

A Phase 2 clinical trial evaluating CPAP/PEEP and Standard management practices for Infant, Newborn and 5 related conditions. Completed, enrolled 104 participants across 6 sites.

Detailed Summary

This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants \<28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP and no PEEP if the infant required PPV (the control group).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Bronchopulmonary Dysplasia, Continuous Positive Airway Pressure

CountriesUnited States

CollaboratorsNational Center for Research Resources (NCRR)

Timeline

Phase 2CompletedFinished

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2002

Primary CompletionJan 2003

First PostedOct 2010

TodayJul 2026

First PostedOct 18, 2010

Enrollment StartJul 1, 2002

Primary CompletionJan 1, 2003

TodayJul 1, 2026

Enrollment to primary: 6 monthsPosted 15.7 years ago

Interventions

CPAP/PEEPdevice

Infants received 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV.

Standard management practicesdevice

Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used.