Nasal interfaces for CPAP- what is best for the preterm infant?

Completed

• Conditions: Preterm infants between 26-32 weeks gestation requiring continuous positive airway pressure

• Registration Number: CTRI/2012/08/002868
• Lead Sponsor: All India Institute of medical sciences

Brief Summary

This study is a randomized, open label parallel group single centre study comparing the efficacy and safety of CPAP delivery through nasal masks versus bi-nasal prongs in preterm babies with respiratory distress syndrome. The efficacy will be measured as the area under the curve of FiO2 requirement against time during the first 72 hours of CPAP application and safety will be measured by the incidence of nasal trauma and air leaks in both groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-20
• Last Update Posted: 2013-10-17

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Preterm babies of 26+0 – 32+6 weeks of gestation Respiratory distress requiring CPAP within 6 hours of life Informed parental consent.

Exclusion Criteria

Major congenital malformations Any known anomaly known to interfere with delivery of CPAP such as congenital diaphragmatic hernia, trachea oesophageal fistula, choanal atresia, cleft palate and nasal deformities, severe cardiovascular instability.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Area under the curve of FiO2 against time during the first 72 hours of CPAP application	1. Area under the curve of FiO2 against time during the first 72 hours of CPAP application | 2. Mean FiO2 requirement at 24 , 48 and 72 hours of CPAP
2. Mean FiO2 requirement at 24 , 48 and 72 hours of CPAP	1. Area under the curve of FiO2 against time during the first 72 hours of CPAP application | 2. Mean FiO2 requirement at 24 , 48 and 72 hours of CPAP

Secondary Outcome Measures

Name	Time	Method
1.Proportion of babies requiring intubation in the first 72 hours of life	2.Proportion of babies who develop nasal trauma

Trial Locations

Locations (1)

Neonatal Intensive care unit- A (Dept of pediatrics), C3 ward, AIIMS; 🇮🇳 Delhi, DELHI, India

Neonatal Intensive care unit- A (Dept of pediatrics), C3 ward, AIIMS

🇮🇳Delhi, DELHI, India

Dr Aparna Chandrasekaran

Principal investigator

9013860039

appubanu@gmail.com