NCT06090981

Early Bolus Surfactant Replacement Therapy Versus Standard Care in Term Neonates With Meconium Aspiration Syndrome

Early Bolus Surfactant Replacement Therapy Versus Standard Care in Term (>=37 Weeks) Neonates With Actant Replacement Therapy Versus Standard Care in Term Neonates With Meconium Aspiration Syndrome: An Open Label Randomized Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Lady Hardinge Medical College · Other Government
• Sex: All
• Age: 30 Minutes – 2 Hours
• Healthy volunteers: Not accepted

Summary

The objective of the study is to compare the total duration of respiratory support in term neonates (≥37weeks) with meconium aspiration syndrome, who are provided early(≤2hr) bolus surfactant therapy versus standard care.

Detailed description

Enrolled participants will be randomly assigned to one of two study groups: 1. early(≤2hr) bolus surfactant replacement therapy or 2. standard care Intervention group: The neonates enrolled in this group will receive early bolus surfactant replacement therapy within 2hr of life. Control group: The neonates enrolled in this group will receive standard care according to standard unit protocol

Conditions

• Meconium Aspiration Syndrome
• Surfactant Dysfunction

Interventions

Type	Name	Description
DRUG	Bovine surfactant	Dose of surfactant: 4ml/kg Type of surfactant: 4ml/kg

Timeline

• Start date: 2022-03-12
• Primary completion: 2024-02-12
• Completion: 2024-03-12
• First posted: 2023-10-19
• Last updated: 2024-07-09

Locations

1 site across 1 country: India