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

Meconium Aspiration Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06090981
• Other study ID #: LHMC/IEC/2021/03/69
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2022
• Est. completion date: March 12, 2024

Study information

• Verified date: October 2023
• Source: Lady Hardinge Medical College
• Contact: Sushma Nangia, MD, DM
• Phone: +919810838181
• Email: drsnangia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 12, 2024
• Est. primary completion date: January 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Minutes to 2 Hours

Eligibility

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

Related Conditions & MeSH terms

• Meconium Aspiration Syndrome
• Surfactant Dysfunction
• Syndrome

Intervention

Drug:
• Bovine surfactant
Dose of surfactant: 4ml/kg Type of surfactant: 4ml/kg

Locations

Country	Name	City	State
India	Lady Hardinge Medical College	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Lady Hardinge Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Total respiratory support	Combined duration of invasive + non invasive ventilation	Birth to 28 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Duration of Mechanical Ventilation	Total duration of Mechanical Ventilation in days	Birth to 28 days
Secondary	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
Secondary	Complications	Incidence of PPHN, Pneumothorax, HIE, sepsis, airlocks,	Birth to 28 days
Secondary	Mortality	All cause mortality	Birth to 28 days
Secondary	Duration of hospital stay	Total duration of hospital stay in days	Birth to 28 days