Status:
COMPLETED
Early Bolus Surfactant Replacement Therapy Versus Standard Care in Term Neonates With Meconium Aspiration Syndrome
Lead Sponsor:
Lady Hardinge Medical College
Conditions:
Meconium Aspiration Syndrome
Surfactant Dysfunction
Eligibility:
All Genders
30-2 years
Phase:
NA
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 ...
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 g...
Eligibility Criteria
Inclusion
- 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
- Major congenital malformation
- Antenatal diagnosed CHD
- Hydrops fetalis
- Air leaks before enrolment
Key Trial Info
Start Date :
March 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06090981
Start Date
March 12 2022
End Date
March 12 2024
Last Update
July 9 2024
Active Locations (1)
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1
Lady Hardinge Medical College
New Delhi, National Capital Territory of Delhi, India, 110001