Less invasive surfactant administration vs Intubation, surfactant and extubation in preterm neonates with respiratory distress syndrome

Phase 1

Not yet recruiting

• Conditions: Respiratory distress syndrome of newborn,

• Registration Number: CTRI/2021/04/032720
• Lead Sponsor: Dr Ashu Jamwal

Brief Summary

This study is a open labelled, two parallel arm, randomized controlled trail comparing less invasive surfactant administration (LISA) with conventional INSURE method of surfactant administration in preterm neonates with respiratory distress syndrome. Primary outcome will be the need for mechanical ventilation within 72 hours of life. Secondary outcomes will be Requirement of repeat dose of surfactant, pneumothorax, early onset sepsis, duration of oxygen requirement, duration of hospital stay, apnea, bradycardia, or desaturation during surfactant administration, mortality.

LISA will be compared as a method to INSURE method for surfactant administration.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-15
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

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

Inclusion Criteria

• Gestational age ≤ 34 weeks 2.
• Diagnosis of RDS based on clinical signs and confirmation by chest x ray findings and need for NIV support ( FiO2 >30 %; PEEP >6 H2O) to maintain saturation between 90% and 95% in the first 6 hours of life.

Exclusion Criteria

• Severe RDS been treated with endotracheal intubation 2.
• Major congenital malformation or complex CHD 3.
• Pulmonary haemorrhage 4.
• Cardiopulmonary failure 5.
• Congenital genetic metabolic disease 6.
• Gestational age less than 28 weeks 7.
• Transferred out of NICU with surgical treatment or other intervention.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Need for mechanical ventilation in first 72 hours	First 72 hours after surfactant administration

Secondary Outcome Measures

Name	Time	Method
Requirement of repeat dose of surfactant
Pneumothorax	During hospitalisation
Early onset sepsis	72 hours
Duration of oxygen requirement	During hospitalisation
Duration of hospital stay	During hospitalisation
Apnea, bradycardia, or desaturation
Mortality	During hospitalisation

Trial Locations

Locations (1)

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

Government medical College Jammu

🇮🇳JAMMU, & KASHMIR, India

Dr Jeevita Raina

Principal investigator

8492081614

jeevitajanvi@gmail.com