n-CPAP Versus n-BiPAP and NIPPV for Postextubation in RDS in Preterms

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome

• Registration Number: NCT01770925
• Lead Sponsor: Ain Shams University

Brief Summary

non-invasive ventilation in preterms complaining from RDS a randomized, controlled trial to compare between capap, n-bipap and NIPPV

Detailed Description

The primary aim of this study is to compare the impact of early extubation to nasal continuous positive airway pressure (n-CPAP) versus nasal Bilevel positive airway pressure (n-BiPAP) and non invasive positive pressure ventilation(NIPPV) on the need for mechanical ventilation via endotracheal tube (MVET) to 7 days of age or less in preterm infants less than or equal to 34 weeks' gestation requiring intubation and surfactant if indicated for respiratory distress syndrome within 120 min of delivery . Second aim is to compare different outcomes of post-extubation n-CPAP , n-BiPAPand NIPPV.

Study Timeline

• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-18
• Study Start: 2017-05-01
• Primary Completion: 2019-04-01
• Study Completion: 2019-05-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-03
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• preterm infants lessthan 34wk

Exclusion Criteria

• preterms less than 1000 g birth weight
• infants with apgar 0at 1 min
• presenceofany other cause of respiratory distress as: congenital malformation affecting the cardiorespiratory system ,neuromuscular disease ,fetal hydrops , interventricular hemorrhage and chromosomal aberrations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Failure of extubation during the first 48 hours post-extubation	during the first 48 hours post-extubation	This will be defined as: 1. Uncompensated respiratory acidosis defined as pH less than 7.2 and partial pressure of carbon dioxide of more than 60 mmHg (or); 2. Major apnea requiring mask ventilation

Secondary Outcome Measures

Name	Time	Method
total days of non invasive ventilation	for 10 days from the hour of extubation	anytime requiring respiratory support during a 24 hour clock counted as a day
length of hospital stay	30 days postnatal age	time of total admission
pneumothorax	10 days post extubation	air leak detected and was evident in chest x ray

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt