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

Lady Hardinge Medical College60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Meconium Aspiration Syndrome Surfactant Dysfunction

Interventions

Bovine surfactantDRUG

Dose of surfactant: 4ml/kg Type of surfactant: 4ml/kg

Eligibility

Sex: ALLMin age: 30 MinutesMax age: 2 Hours

Medical Language ↔ Plain English

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

Locations (1)

Lady Hardinge Medical College

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

Duration of Total respiratory support

Combined duration of invasive + non invasive ventilation

Time frame: Birth to 28 days

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Birth to 28 days

Duration of Mechanical Ventilation

Total duration of Mechanical Ventilation in days

Time frame: 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

Time frame: Birth to 28 days

Complications

Incidence of PPHN, Pneumothorax, HIE, sepsis, airlocks,

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.