NCT03630367

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 3, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2021

Enrollment Period

1.9 years

First QC Date

August 4, 2018

Last Update Submit

April 22, 2021

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (1)

  • the mean difference in the Apgar score after birth

    Assessment of fetal general condition

    1 minute

Study Arms (2)

study group

EXPERIMENTAL

women will receive dexamethasone 8 mg intramuscular every 8 hours plus single injection of L-carnitine 1 gm slow intravenous

Drug: DexamethasoneDrug: 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

DexamethasoneDRUG

Intramuscular injection 8 mg

control groupstudy group
L-Carnitine 1G/5mL InjectionDRUG

slow intravenous injection

study group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women between 30-37 weeks
  • singleton pregnancy

You may not qualify if:

  • congenital malformed fetus
  • Extreme premature

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Conditions

Premature Birth

Interventions

DexamethasoneCarnitineInjections

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsDrug Administration RoutesDrug TherapyTherapeutics
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 4, 2018

First Posted

August 14, 2018

Study Start

October 3, 2018

Primary Completion

September 1, 2020

Study Completion

October 1, 2020

Last Updated

April 23, 2021

Record last verified: 2021-04

Locations

EG(1)