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

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

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Device: N-CPAP; Device: n-BiPAP; Device: 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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 1138
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 week (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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-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.
ACTIVE_COMPARATOR: 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: 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).
ACTIVE_COMPARATOR: 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	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Rania EL-Farrash, MD, Professor of paediatrics Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ACTUAL): April 1, 2019
• Study Completion (ACTUAL): May 1, 2019

Study Registration Dates

• First Submitted: January 15, 2013
• First Submitted That Met QC Criteria: January 16, 2013
• First Posted (ESTIMATE): January 18, 2013

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 3, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: Ain Shams University (Registry Identifier: passant abdalla); riham samy (REGISTRY: rania ali)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No