Early Bolus Surfactant Replacement Therapy Versus Standard Care in Term Neonates With Meconium Aspiration Syndrome
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 12, 2022
CompletedFirst Submitted
Initial submission to the registry
October 13, 2023
CompletedFirst Posted
Study publicly available on registry
October 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2024
CompletedJuly 9, 2024
July 1, 2024
1.9 years
October 13, 2023
July 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of Total respiratory support
Combined duration of invasive + non invasive ventilation
Birth to 28 days
Secondary Outcomes (8)
Severity of respiratory distress
Birth to 28 days
Proportion of neonates requiring mechanical ventilation
Birth to 28 days
Proportion of neonates requiring Non Invasive Ventilation
Birth to 28 days
Duration of Mechanical Ventilation
Birth to 28 days
Duration of oxygen therapy
Birth to 28 days
- +3 more secondary outcomes
Study Arms (2)
Early bolus surfactant replacement therapy
EXPERIMENTALNeonates randomized to this group will receive early bolus surfactant replacement therapy within 2hr of life
Standard care
NO INTERVENTIONNeonates randomized to this group will be managed as per standard protocol in the neonatal unit.
Interventions
Dose of surfactant: 4ml/kg Type of surfactant: 4ml/kg
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Major congenital malformation
- Antenatal diagnosed CHD
- Hydrops fetalis
- Air leaks before enrolment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lady Hardinge Medical College
New Delhi, National Capital Territory of Delhi, 110001, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sushma Nangia, MD, DM (Neo)
Lady Hardinge Medical College, New Delhi, India
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Sushma Nangia, Director Professor & Head, Neonatology
Study Record Dates
First Submitted
October 13, 2023
First Posted
October 19, 2023
Study Start
March 12, 2022
Primary Completion
February 12, 2024
Study Completion
March 12, 2024
Last Updated
July 9, 2024
Record last verified: 2024-07