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

Sponsor

Lady Hardinge Medical College (Other)

Overall Status

Recruiting

CT.gov ID

NCT06090981

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Meconium Aspiration Syndrome Surfactant Dysfunction	Drug: Bovine surfactant	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 12, 2022

Anticipated Primary Completion Date :

Jan 12, 2024

Anticipated Study Completion Date :

Mar 12, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Duration of Total respiratory support [Birth to 28 days]
Combined duration of invasive + non invasive ventilation

Secondary Outcome Measures

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 mechanical ventilation [Birth to 28 days]
The babies will be assessed for the need for mechanical ventilation as per standard protocol
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 Mechanical Ventilation [Birth to 28 days]
Total duration of Mechanical Ventilation in days
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
Complications [Birth to 28 days]
Incidence of PPHN, Pneumothorax, HIE, sepsis, airlocks,
Mortality [Birth to 28 days]
All cause mortality
Duration of hospital stay [Birth to 28 days]
Total duration of hospital stay in days

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Minutes to 2 Hours

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lady Hardinge Medical College	New Delhi	Delhi	India	110001

Sponsors and Collaborators

Lady Hardinge Medical College

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sushma Nangia, M.D., Dr. Sushma Nangia, Director Professor & Head, Neonatology, Lady Hardinge Medical College

ClinicalTrials.gov Identifier:

NCT06090981

Other Study ID Numbers:

LHMC/IEC/2021/03/69

First Posted:

Oct 19, 2023

Last Update Posted:

Oct 19, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Meconium Aspiration Syndrome

Syndrome

Pulmonary Surfactants

Study Results

No Results Posted as of Oct 19, 2023