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

Not Applicable

Completed

• Conditions: Meconium Aspiration Syndrome; Surfactant Dysfunction
• Interventions: Drug: Bovine surfactant

• Registration Number: NCT06090981
• Lead Sponsor: Lady Hardinge Medical College

Brief 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

Study Timeline

• Study Start: 2022-03-12
• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-13
• Study First Posted: 2023-10-19
• Primary Completion: 2024-02-12
• Study Completion: 2024-03-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Gestation age ≥ 37 week
• Cephalic presentation
• Singleton pregnancy
• Age < 2 hours
• Baby delivered through meconium stained amniotic fluid
• Presence of respiratory distress (DOWNE's score ≥4)

Exclusion Criteria

• Major congenital malformation
• Antenatal diagnosed CHD
• Hydrops fetalis
• Air leaks before enrolment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early bolus surfactant replacement therapy	Bovine surfactant	Neonates randomized to this group will receive early bolus surfactant replacement therapy within 2hr of life

Primary Outcome Measures

Name	Time	Method
Duration of Total respiratory support	Birth to 28 days	Combined duration of invasive + non invasive ventilation

Secondary Outcome Measures

Name	Time	Method
Duration of hospital stay	Birth to 28 days	Total duration of hospital stay in days
Proportion of neonates requiring mechanical ventilation	Birth to 28 days	The babies will be assessed for the need for mechanical ventilation as per standard protocol
Severity of respiratory distress	Birth to 28 days	The severity of respiratory distress will be assessed using Downe's score. These parameters will be documented hourly within first 2 hours before surfactant replacement and in post lavage unto first 24 hrs, 2 hourly unto 48 hrs, and 4 holy thereafter till cessation of respiratory distress
Proportion of neonates requiring Non Invasive Ventilation	Birth to 28 days	The babies will be assessed for the need for non invasive ventilation as per standard protocol
Duration of oxygen therapy	Birth to 28 days	The duration of oxygen therapy, mode of delivery, Fio2 and flow rates will be documented hourly within first 2 hours before surfactant replacement and in post lavage unto first 24 hrs, 2 hourly unto 48 hrs, and 4 holy thereafter till cessation of respiratory distress
Mortality	Birth to 28 days	All cause mortality
Complications	Birth to 28 days	Incidence of PPHN, Pneumothorax, HIE, sepsis, airlocks,
Duration of Mechanical Ventilation	Birth to 28 days	Total duration of Mechanical Ventilation in days

Trial Locations

Locations (1)

Lady Hardinge Medical College; 🇮🇳 New Delhi, Delhi, India