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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Meconium Aspiration Syndrome, Surfactant Dysfunction

Intervention / Treatment
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* Drug: Bovine surfactant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Minutes
Maximum Age: 2 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |