NCT01770925

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

Non-invasive Ventilation as a Post Extubation Mode for RDS: a Randomized, Cotrolled Trial to Compare n-CPAP by n- Bipap and NIPPV

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 1 Day – 7 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Distress Syndrome

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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).
DEVICE	NIPPV	The NIPPV group will receive at extubation a positive end expiratory pressure of 5 cm water , a peak inspiratory pressure of 9 cm of water, RR of 35 and ti of 0.32

Timeline

• Start date: 2017-05-01
• Primary completion: 2019-04-01
• Completion: 2019-05-01
• First posted: 2013-01-18
• Last updated: 2020-05-05

Locations

1 site across 1 country: Egypt