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

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.

Study Overview

• Status: Completed
• Conditions: Meconium Aspiration Syndrome; Surfactant Dysfunction
• Intervention / Treatment: Drug: Bovine surfactant

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110001
      • Lady Hardinge Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early bolus surfactant replacement therapy; Neonates randomized to this group will receive early bolus surfactant replacement therapy within 2hr of life	Drug: Bovine surfactant; Dose of surfactant: 4ml/kg Type of surfactant: 4ml/kg
No Intervention: Standard care; Neonates randomized to this group will be managed as per standard protocol in the neonatal unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Total respiratory support	Combined duration of invasive + non invasive ventilation	Birth to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of respiratory distress	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	Birth to 28 days
Proportion of neonates requiring mechanical ventilation	The babies will be assessed for the need for mechanical ventilation as per standard protocol	Birth to 28 days
Proportion of neonates requiring Non Invasive Ventilation	The babies will be assessed for the need for non invasive ventilation as per standard protocol	Birth to 28 days
Duration of Mechanical Ventilation	Total duration of Mechanical Ventilation in days	Birth to 28 days
Duration of oxygen therapy	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	Birth to 28 days
Complications	Incidence of PPHN, Pneumothorax, HIE, sepsis, airlocks,	Birth to 28 days
Mortality	All cause mortality	Birth to 28 days
Duration of hospital stay	Total duration of hospital stay in days	Birth to 28 days

Collaborators and Investigators

• Sponsor: Lady Hardinge Medical College
• Investigators: Study Chair: Sushma Nangia, MD, DM (Neo), Lady Hardinge Medical College, New Delhi, India

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2022
• Primary Completion (Actual): February 12, 2024
• Study Completion (Actual): March 12, 2024

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 5, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Fetal Diseases; Pregnancy Complications; Lung Injury; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Syndrome; Meconium Aspiration Syndrome; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: LHMC/IEC/2021/03/69

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No