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Effects of L‑Carnitine Supplementation on Respiratory Distress Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03630367
Recruitment Status : Suspended (Unavailability of the medication)
First Posted : August 14, 2018
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

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

Condition or disease Intervention/treatment Phase
Premature Birth Drug: Dexamethasone Drug: L-Carnitine 1G/5mL Injection Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Adding L‑Carnitine With Dexamethasone on Respiratory Distress Syndrome Development in Preterm Infants
Actual Study Start Date : October 3, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020


Arm Intervention/treatment
Experimental: study group
women will receive dexamethasone 8 mg intramuscular every 8 hours plus single injection of L-carnitine 1 gm slow intravenous
Drug: Dexamethasone
Intramuscular injection 8 mg

Drug: L-Carnitine 1G/5mL Injection
slow intravenous injection

Active Comparator: control group
women will receive dexamethasone 8 mg intramuscular every 8 hours plus single injection of saline 1 gm slow intravenous
Drug: Dexamethasone
Intramuscular injection 8 mg




Primary Outcome Measures :
  1. the mean difference in the Apgar score after birth [ Time Frame: 1 minute ]
    Assessment of fetal general condition



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women between 30-37 weeks
  • singleton pregnancy

Exclusion Criteria:

  • congenital malformed fetus
  • Extreme premature

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630367


Locations
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Egypt
Ahmed Abbas
Assiut, Cairo, Egypt, 002
Sponsors and Collaborators
Assiut University
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Responsible Party: Ahmed Mohamed Abbas, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03630367    
Other Study ID Numbers: LCPET
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Premature Birth
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents