CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 186 enrolled
Drug / intervention
"IPPV group" +1 moreprocedure
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/NCT01739114
NCT01739114N/ACompleted
CompareCT.gov

Sustained Inflations to Achieve Lung Aeration at Birth - a Randomized Control Trial

University of Alberta·interventional·Posted Dec 3, 2012·Updated Mar 15, 2017

In Brief

A clinical study evaluating "IPPV group" and SI group for Bronchopulmonary Dysplasia. Completed, enrolled 186 participants across 1 site.

Detailed Summary

To determine if respiratory support at birth guided by RFM decreases BPD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBronchopulmonary Dysplasia
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 3, 2012
Enrollment StartMay 1, 2013
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.6 years ago

Interventions

"IPPV group"procedure

Infants randomized into the "IPPV group" will receive mask IPPV with an initial PIP of 20 cmH2O and PEEP of 5 cm H2O, and a ventilation rate of 40-60 inflations/min until spontaneously breathing, at which time CPAP will be provided.

SI groupprocedure

Infants randomized into the "SI group" will receive two initial sustained inflations with a PIP of 20 cmH2O. After the two initial SIs infants will receive PEEP of 5 cm H2O and then CPAP if breathing spontaneously or, if found to have apnea or laboured breathing, mask IPPV with a PIP of 20 cmH2O and PEEP of 5 cmH2O at a rate of 40 to 60 bpm until spontaneously breathing, at which time CPAP will be provided