A clinical trial to compare two different nasal interfaces for non-invasive ventilation support of preterm infants with respiratory distress in a tertiary care hospital

Not yet recruiting

• Conditions: Respiratory distress of newborn, unspecified,

• Registration Number: CTRI/2021/03/032409
• Lead Sponsor: Dr Anuj Bhatti

Brief Summary

This study is a open labelled, two parallel arm, randomized controlled trail comparing two different nasal interfaces for non-invasive ventilation support in preterm infants with respiratory distress in a tertiary care hospital. The primary outcome measure will be failure of CPAP(Continuous positive airway pressure) within 72 hours of life. The secondary outcomes were: failure of CPAP by 7 days of age, proportion of infants who received post-randomization surfactant, total duration of CPAP, incidence of death during hospital stay, pnemothorax, blood culture positive sepsis (systemic evidence of infection along with a positive blood culture), Bronchopulmonary dysplasia (need for supplemental oxygen at 36 weeks postmenstrual age), intraventricular hemorrhage (grade 2 and above), periventricular leucomalacia (any grade),  and necrotizing enterocolitis (stages 2 and 3).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-04
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• 1. Inborn babies with gestational age between 28weeks to 34weeks and birth weight more than or equal to 1000 g.
• 2. The presence of respiratory distress (presence of at least two out of three signs: tachypnoea > 60 per minute, intercostal retractions and expiratory grunt) within 6h of life requiring nasal CPAP.

Exclusion Criteria

• 1. Intubation soon after birth 2) APGAR score ≤3 3) Life threatening malformations such as congenital diaphragmatic hernia, trachea- oesophageal fistula, and malformations that would prevent establishment of CPAP due to the anatomical defect such as Pierre- Robinson syndrome and choanal atresia.
• 4. Conditions where intubation and mechanical ventilation are directly indicated such as apnea and hypotensive shock.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Failure of CPAP within first 72 hrs of life	first 72 hrs of life

Secondary Outcome Measures

Name	Time	Method
Maximum CPAP pressure (cm H20)	72 hours
death	during hospital stay
CPAP failure	7 days
Pneumothorax	during hospitalization
Bronchopulmonary dysplasia	by 36 weeks post menstrual age
Need for intubation and mechanical ventilation	72 hours of life
Remained on CPAP by 7 days of age	7 days
Total duration of CPAP in hours	hours
Feeding intolerance	any time during hospitalization
Remained on CPAP by 72 h of age	72 hours
Surfactant (post randomization)	hours
Nasal injury score	0-7
Suspected sepsis	during hospitalization
Culture proven sepsis	during the hospitalization
Necrotizing enterocolitis	Stage 2 and 3 during hospitilization
Intraventricular hemorrhage	(greater than grade 1)
Pulmonary hemorrhage	any time during hospitalization

Trial Locations

Locations (1)

Government Medical College, Jammu; 🇮🇳 JAMMU, & KASHMIR, India

Government Medical College, Jammu

🇮🇳JAMMU, & KASHMIR, India

Dr Anuj Bhatti

Principal investigator

9419221115

bhatti.anuj@gmail.com