Back to resultsEarly Bolus Surfactant Replacement Therapy Versus Standard Care in Term Neonates With Meconium Aspiration Syndrome
Primary Purpose
Meconium Aspiration Syndrome, Surfactant Dysfunction
Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Bovine surfactant
Sponsored by
About this trial
This is an interventional treatment trial for Meconium Aspiration Syndrome
Eligibility Criteria
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
Sites / Locations
- Lady Hardinge Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Early bolus surfactant replacement therapy
Standard care
Arm Description
Neonates randomized to this group will receive early bolus surfactant replacement therapy within 2hr of life
Neonates randomized to this group will be managed as per standard protocol in the neonatal unit.
Outcomes
Primary Outcome Measures
Duration of Total respiratory support
Combined duration of invasive + non invasive ventilation
Secondary Outcome Measures
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
Proportion of neonates requiring mechanical ventilation
The babies will be assessed for the need for mechanical ventilation as per standard protocol
Proportion of neonates requiring Non Invasive Ventilation
The babies will be assessed for the need for non invasive ventilation as per standard protocol
Duration of Mechanical Ventilation
Total duration of Mechanical Ventilation in 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
Complications
Incidence of PPHN, Pneumothorax, HIE, sepsis, airlocks,
Mortality
All cause mortality
Duration of hospital stay
Total duration of hospital stay in days
Full Information
NCT ID
NCT06090981
First Posted
October 13, 2023
Last Updated
October 13, 2023
Sponsor
Lady Hardinge Medical College
1. Study Identification
Unique Protocol Identification Number
NCT06090981
Brief Title
Early Bolus Surfactant Replacement Therapy Versus Standard Care in Term Neonates With Meconium Aspiration Syndrome
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 12, 2022 (Actual)
Primary Completion Date
January 12, 2024 (Anticipated)
Study Completion Date
March 12, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lady Hardinge Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meconium Aspiration Syndrome, Surfactant Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early bolus surfactant replacement therapy
Arm Type
Experimental
Arm Description
Neonates randomized to this group will receive early bolus surfactant replacement therapy within 2hr of life
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Neonates randomized to this group will be managed as per standard protocol in the neonatal unit.
Intervention Type
Drug
Intervention Name(s)
Bovine surfactant
Intervention Description
Dose of surfactant: 4ml/kg Type of surfactant: 4ml/kg
Primary Outcome Measure Information:
Title
Duration of Total respiratory support
Description
Combined duration of invasive + non invasive ventilation
Time Frame
Birth to 28 days
Secondary Outcome Measure Information:
Title
Severity of respiratory distress
Description
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
Title
Proportion of neonates requiring mechanical ventilation
Description
The babies will be assessed for the need for mechanical ventilation as per standard protocol
Time Frame
Birth to 28 days
Title
Proportion of neonates requiring Non Invasive Ventilation
Description
The babies will be assessed for the need for non invasive ventilation as per standard protocol
Time Frame
Birth to 28 days
Title
Duration of Mechanical Ventilation
Description
Total duration of Mechanical Ventilation in days
Time Frame
Birth to 28 days
Title
Duration of oxygen therapy
Description
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
Title
Complications
Description
Incidence of PPHN, Pneumothorax, HIE, sepsis, airlocks,
Time Frame
Birth to 28 days
Title
Mortality
Description
All cause mortality
Time Frame
Birth to 28 days
Title
Duration of hospital stay
Description
Total duration of hospital stay in days
Time Frame
Birth to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Minutes
Maximum Age & Unit of Time
2 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sushma Nangia, MD, DM
Phone
+919810838181
Email
drsnangia@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tapas Bandyopadhyay, MD, DM (Neo)
Phone
+919910371315
Email
dr.tapasbanerjee@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sushma Nangia, MD, DM (Neo)
Organizational Affiliation
Lady Hardinge Medical College, New Delhi, India
Official's Role
Study Chair
Facility Information:
Facility Name
Lady Hardinge Medical College
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sushma Nangia, DM (NEO)
Phone
+919810838181
Email
drsnangia@gmail.com
First Name & Middle Initial & Last Name & Degree
Tapas Bandyopadhyay, MD, DM (Neo)
Phone
+919910371315
Email
dr.tapasbanerjee@gmail.com
First Name & Middle Initial & Last Name & Degree
Sushma Nangia, MD, DM (Neo)
First Name & Middle Initial & Last Name & Degree
Videesh K Sombattina, MD
12. IPD Sharing Statement
Learn more about this trial
Early Bolus Surfactant Replacement Therapy Versus Standard Care in Term Neonates With Meconium Aspiration Syndrome
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