Back to resultsEffects of L-Carnitine Supplementation on Respiratory Distress Syndrome
Primary Purpose
Premature Birth
Status
Withdrawn
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Dexamethasone
L-Carnitine 1G/5mL Injection
Sponsored by
About this trial
This is an interventional prevention trial for Premature Birth
Eligibility Criteria
Inclusion Criteria:
- Pregnant women between 30-37 weeks
- singleton pregnancy
Exclusion Criteria:
- congenital malformed fetus
- Extreme premature
Sites / Locations
- Ahmed Abbas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
study group
control group
Arm Description
women will receive dexamethasone 8 mg intramuscular every 8 hours plus single injection of L-carnitine 1 gm slow intravenous
women will receive dexamethasone 8 mg intramuscular every 8 hours plus single injection of saline 1 gm slow intravenous
Outcomes
Primary Outcome Measures
the mean difference in the Apgar score after birth
Assessment of fetal general condition
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03630367
Brief Title
Effects of L-Carnitine Supplementation on Respiratory Distress Syndrome
Official Title
Effects of Adding L-Carnitine With Dexamethasone on Respiratory Distress Syndrome Development in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Unavailability of the medication
Study Start Date
October 3, 2018 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the present study was to investigate the efficacy of L-carnitine therapy on the occurrence and prognosis of respiratory distress syndrome
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
women will receive dexamethasone 8 mg intramuscular every 8 hours plus single injection of L-carnitine 1 gm slow intravenous
Arm Title
control group
Arm Type
Active Comparator
Arm Description
women will receive dexamethasone 8 mg intramuscular every 8 hours plus single injection of saline 1 gm slow intravenous
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Intramuscular injection 8 mg
Intervention Type
Drug
Intervention Name(s)
L-Carnitine 1G/5mL Injection
Intervention Description
slow intravenous injection
Primary Outcome Measure Information:
Title
the mean difference in the Apgar score after birth
Description
Assessment of fetal general condition
Time Frame
1 minute
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant women between 30-37 weeks
singleton pregnancy
Exclusion Criteria:
congenital malformed fetus
Extreme premature
Facility Information:
Facility Name
Ahmed Abbas
City
Assiut
State/Province
Cairo
ZIP/Postal Code
002
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Effects of L-Carnitine Supplementation on Respiratory Distress Syndrome
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