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

Lady Hardinge Medical College

Status: Completed

Conditions: Meconium Aspiration Syndrome; Surfactant Dysfunction

Treatments: Drug: Bovine surfactant

Study type: Interventional

Funder types: Other

Identifiers

NCT06090981

LHMC/IEC/2021/03/69

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 30 minutes to 2 hours old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Early bolus surfactant replacement therapy

Experimental group

Description:

Neonates randomized to this group will receive early bolus surfactant replacement therapy within 2hr of life

Treatment:

Drug: Bovine surfactant

Standard care

No Intervention group

Description:

Neonates randomized to this group will be managed as per standard protocol in the neonatal unit.