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Effects of L‑Carnitine Supplementation on Respiratory Distress Syndrome

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ClinicalTrials.gov Identifier: NCT03630367
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : March 26, 2019
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 : July 2019
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



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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 Recruiting
Assiut, Cairo, Egypt, 002
Contact: ahmed abbas    00201003385183    bmr90@hotmail.com   
Sponsors and Collaborators
Assiut University

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Responsible Party: Ahmed Mohamed Abbas, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03630367     History of Changes
Other Study ID Numbers: LCPET
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

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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
Respiratory Tract Diseases
Infant, Newborn, Diseases
Premature Birth
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Dexamethasone
Dexamethasone acetate
BB 1101
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
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action