Effect of Application of Sustained Lung Inflation on the Respiratory Outcome of Preterm Infants With Respiratory Distress Syndrome

Kasr El Aini Hospital1 site in 1 country160 target enrollmentDecember 21, 2014

ConditionsPreterm Infant

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Preterm Infant
Sponsor: Kasr El Aini Hospital
Enrollment: 160
Locations: 1
Primary Endpoint: Need for invasive mechanical ventilation or death
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized controlled study to investigate the effect of application of sustained lung inflation (SLI) at birth on the respiratory outcome of preterm infants with respiratory distress syndrome.

Detailed Description

Enrolled infants (n=160) were randomized before birth into 2 groups (intervention and control group) in a ratio 1:1. Randomization was done through an online randomizer (www.graphpad.com), and sealed envelopes were used to assign the infant to one of the two groups.

Registry

clinicaltrials.gov

Start Date

December 21, 2014

End Date

September 5, 2017

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kasr El Aini Hospital

Responsible Party

Principal Investigator

Douaa El Saied El Sherbiny

Doctor

Kasr El Aini Hospital

Eligibility Criteria

Inclusion Criteria

•Gestational age ≥ 27 weeks and ≤ 32 weeks
•Appropriate for gestational age
•Weight \>800 grams

Exclusion Criteria

•Major congenital anomalies (congenital heart, cerebral, lung or abdominal malformations)
•Fetal hydrops

Outcomes

Primary Outcomes

Need for invasive mechanical ventilation or death

Time Frame: From birth up to 72 hours of life

Treatment failure; defined as the need for intubation and invasive mechanical ventilation or death

Secondary Outcomes

Bronchopulmonary dysplasia(Assessed at 36 weeks postmenstrual age or discharge, whichever came first)
Duration of invasive mechanical ventilation(From date of birth until the date of discharge home or death from any cause, whichever came first, assessed upto 100 days)
Pneumothorax(From date of birth until the date of discharge home or death from any cause, whichever came first, assessed upto 100 days)