Effect of L-Carnitine Supplementation in Preterm Neonates

Effect of L-Carnitine Supplementation in Preterm Neonates Suffering From Respiratory Distress Syndrome (RDS)

The current study is planned to see the effect of L-carnitine supplementation in preterm neonates suffering from RDS among the local population, as there is no such evidence available for the local population and there are conflicting statistics regarding the discharge rate of these neonates.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Drug: L-carnitine; Drug: Standard care

Detailed Description

Given the contradictory results (discharge rate), additional rigorously designed studies are necessary to elucidate the impact of L-carnitine supplementation on short-term neonatal outcomes, including weight gain, discharge rate, and mortality. The proposed research aims to fill this knowledge gap by systematically evaluating the clinical efficacy and safety of L-carnitine supplementation in L-carnitine-deficient neonates. The findings would provide evidence-based suggestions on whether L-carnitine is a useful, safe, and potentially beneficial adjunct in managing preterm neonates with RDS, particularly in addressing metabolic needs.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Sarfraz, FCPS; Phone Number: +923336464238; Email: drfraz1986@gmail.com
• Study Contact Backup: Name: Athar Razzaq, FCPS; Phone Number: +923007183545; Email: athar.razzaq@tih.org.pk

Study Locations

• Pakistan
  • Punjab Province
    • Muzaffargarh, Punjab Province, Pakistan, 32400
      • Recruiting
      • Recep Tayyip Erdogan Hospital/Indus Hospital & Health Network
      • Contact: Muhammad Sarfraz, FCPS; Phone Number: +923336464238; Email: drfraz1986@gmail.com
      • Contact: Athar Razzaq, PCPS; Phone Number: +923007183545; Email: athar.razzaq@tih.org.pk
      • Principal Investigator: Muhammad Sarfraz, FCPS
      • Principal Investigator: Athar Razzaq, FCPS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Preterm neonates
• Either gender
• With RDS
• Admitted to the neonatal intensive care unit (NICU) within 24 hours of birth .

Exclusion Criteria:

• Neonates with gastrointestinal tract (GIT) anomalies
• With confirmed or suspected sepsis at the time of enrollment
• Neonates whose clinical condition contraindicates study participation (e.g., expected survival <48 hours, as judged by the neonatologist).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: L-carnitine Group; Patients will receive L-carnitine at a therapeutic dosage of 30 mg/kg/day, in conjunction with a standard care regimen comprising a total dosage of 100 mg phospholipids/kg birth weight (4 ml/kg), divided into four quarter-dose aliquots.	Drug: L-carnitine; Patients will receive L-carnitine at a therapeutic dosage of 30 mg/kg/day, in conjunction with a standard care regimen comprising a total dosage of 100 mg phospholipids/kg birth weight (4 ml/kg), divided into four quarter-dose aliquots.; Drug: Standard care; Patients will get a standard care regimen comprising a total dosage of 100 mg phospholipids/kg birth weight (4 ml/kg), divided into four quarter-dose aliquots.
Experimental: No L-carnitine Group; Patients will get only a standard care regimen comprising a total dosage of 100 mg phospholipids/kg birth weight (4 ml/kg), divided into four quarter-dose aliquots.	Drug: Standard care; Patients will get a standard care regimen comprising a total dosage of 100 mg phospholipids/kg birth weight (4 ml/kg), divided into four quarter-dose aliquots.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	If a patient will die in the hospital, it will be considered as mortality, otherwise taken as discharged alive.	30 days
Change in Weight	Change in weight will be measured at discharge and compared with the baseline measure. An increase in the weight from baseline will be considered effectiveness of the treatment.	30 days

Collaborators and Investigators

• Sponsor: Muhammad Aamir Latif
• Investigators: Principal Investigator: Muhammad Sarfraz, FCPS, Recep Tayyip Erdogan Hospital, Muzaffargarh; Principal Investigator: Athar Razzaq, FCPS, Recep Tayyip Erdogan Hospital, Muzaffargarh

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Distress Syndrome; Health Services Administration; Health Care Quality, Access, and Evaluation; Organic Chemicals; Quality of Health Care; Quality Indicators, Health Care; Amines; Quaternary Ammonium Compounds; Trimethyl Ammonium Compounds; Standard of Care; Carnitine
• Other Study ID Numbers: Dr-Sarfraz-DGK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data can be shared on a reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No