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

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome
• Interventions: Device: N-CPAP; Device: n-BiPAP; Device: NIPPV

• 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

Arm && Interventions

Group	Intervention	Description
n-CPAP	N-CPAP	* The n-CPAP group will receive at extubation a single level continuous positive airway pressure of 7 cm water for at least 48 hours before weaning is commenced. If the infant is stable for the preceding 48 hours defined by having fewer than three minor apneas and no increase in oxygen requirement, weaning will be permitted. * CPAP will be decreased from 6 cm water by 1 cm water every 24 hours if tolerated based on the above criteria. This will be done until a pressure of 4 cm water is reached. * If a pressure of 4 cm water is successfully tolerated for 48 hours then time off n-CPAP will be allowed. Thereafter, no fixed weaning regime based on number of hours in a day the infant will be allowed to come off CPAP will be prescribed.
n-BiPAP	n-BiPAP	* The n-BiPAP group will receive at extubation a mean airway pressure of 7 cm water (positive end expiratory pressure of 5 cm water and peak inspiratory pressure of 9 cm of water). Inspiratory time of one second and respiratory rate of 30/min will always be maintained. * The infant will then receive a mean airway pressure of 5 cm water (positive end expiratory pressure of 4 cm water and peak inspiratory pressure of 6 cm of water).
NIPPV	NIPPV	o The NIPPV group will receive at extubation a positive end expiratory pressure of 5 cm water, peak inspiratory pressure of 15cm of water, RRof35 and Ti of 0.32

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