Effects of L-Carnitine Supplementation on Respiratory Dis... | NCT03630367

Studies
Effects of L-Carnitine Supplementation on Respiratory Distress Syndrome

NCT03630367

Sponsor

Assiut University

Status

Withdrawn

Last Update Posted

Apr 23, 2021Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Premature Birth

Interventions

Dexamethasone
L-Carnitine 1G/5mL Injection

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unavailability of the medication

Expanded Access Info

Start Date

Oct 3, 2018Actual

Primary Completion Date

Sep 2020Estimated

Completion Date

Oct 2020Estimated

First Submitted Date

Aug 4, 2018

First Submission Date that Met QC Criteria

Aug 10, 2018

First Posted Date

Aug 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2021

Last Update Posted Date

Apr 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group	Experimental	women will receive dexamethasone 8 mg intramuscular every 8 hours plus single injection of L-carnitine 1 gm slow intravenous	Drug: Dexamethasone Drug: L-Carnitine 1G/5mL Injection
control group	Active Comparator	women will receive dexamethasone 8 mg intramuscular every 8 hours plus single injection of saline 1 gm slow intravenous	Drug: Dexamethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	Intramuscular injection 8 mg	control group study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the mean difference in the Apgar score after birth	Assessment of fetal general condition	1 minute

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women between 30-37 weeks
singleton pregnancy

Exclusion Criteria:

congenital malformed fetus
Extreme premature

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Abbas		Assiut	Cairo Governorate	002	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone
D002331	Carnitine
D007267	Injections

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided