NCT07437391

Effect of L-Carnitine Supplementation in Preterm Neonates

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Muhammad Aamir Latif · Academic / Other
• Sex: All
• Age: 1 Hour – 24 Hours
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Respiratory Distress Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Pakistan