A clinical trial to study the effects of different types of interfaces placed over nose on the safety and efficacy of non invasive ventilation in immature babies

Not Applicable

Completed

• Conditions: Health Condition 1: P22- Respiratory distress of newborn

• Registration Number: CTRI/2020/07/026324
• Lead Sponsor: Institute of Post Graduate Medical Education and Research Department of Neonatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-04-27
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 210

Inclusion Criteria

1.Preterm newborn (gestational age of <37 completed weeks at birth) requiring NIPPV as primary respiratory support within 6 h of birth .Thus any preterm baby having respiratory distress within 6 h of birth, objectified as Silverman score of more than 3, will be eligible for non-invasive positive pressure ventilation.

2.Preterm newborn requiring NIPPV after extubation within first 7 days of life.Thus

any preterm baby undergoing extubation will also be eligible and will be supported with non-invasive positive pressure ventilation as per study protocol

Exclusion Criteria

1.Presence of lethal congenital malformation or suspected chromosomal anomaly

2.Outborn preterm infants

3.Contraindications of non-invasive ventilation (shock requiring inotropes, cleft lip and palate, choanal atresia, severe perinatal asphyxia with APPGAR at 5 min of 3 or less)

4.Parental refusal of consent for participation in the study

5.Babies already on any form of non-invasive ventilation (continuous positive airway pressure or non-invasive positive pressure ventilation or heated humidified high flow nasal cannula) before randomization. Thus baby who is already on continuous positive airway pressure and require because of continuous positive airway pressure failure will not be included in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the incidence of non-invasive positive pressure ventilation failure requiring intubation and mechanical ventilation within 72 h of initiating respiratory support in preterm newborn in three different groups (continuous nasal mask versus continuous short bi nasal prong versus prong and mask in rotation).Timepoint: 72 hours

Secondary Outcome Measures

Name	Time	Method
complications of non -invasive ventilation (feed intolerance, pulmonary air leak, gastrointestinal perforation, ventilator associated pneumonia)Timepoint: Before discharge or death;Duration of neonatal intensive care unit stay in each groupTimepoint: Before discharge or death;Duration of non-invasive positive pressure ventilation or mechanical ventilation in each groupTimepoint: Before discharge or death;Incidence of nasal trauma as per nasal injury scoring chartTimepoint: 72 hours;Mortality in each groupTimepoint: Before discharge;Oxygen and mean airway pressure (MAP) of non- invasive positive pressure ventilation requirement in each groupTimepoint: 72 hours;To compare the incidence of common neonatal morbidities ( bronchopulmonary dysplasia, necrotizing enterocolitis, sepsis, retinopathy of prematurity, intraventricular hemorrhage, patent ductus arteriosus, ventilator associated pneumonia)Timepoint: Before discharge or death