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

Ain Shams University120 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Respiratory Distress Syndrome

Interventions

N-CPAPDEVICE

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-BiPAPDEVICE

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).

Eligibility

Sex: ALLMin age: 1 DayMax age: 7 Days

Medical Language ↔ Plain English

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

Locations (1)

Ain Shams University

Cairo, Egypt

Outcomes

Primary Outcomes

Failure of 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

Time frame: during the first 48 hours post-extubation

Secondary Outcomes

total days of non invasive ventilation

anytime requiring respiratory support during a 24 hour clock counted as a day

Time frame: for 10 days from the hour of extubation

length of hospital stay

time of total admission

Time frame: 30 days postnatal age

pneumothorax

air leak detected and was evident in chest x ray

Time frame: 10 days post extubation

Data from ClinicalTrials.gov

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