Effect of L-Carnitine Supplementation in Preterm Neonates

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07437391

Enrollment

160

Registered

2026-02-27

Start date

2026-01-01

Completion date

2026-06-30

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome

Brief 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.

Interventions

DRUGL-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.

DRUGStandard 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 24 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Change in Weight	30 days	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.
Mortality	30 days	If a patient will die in the hospital, it will be considered as mortality, otherwise taken as discharged alive.

Countries

Pakistan

Contacts

CONTACTMuhammad Sarfraz, FCPS

drfraz1986@gmail.com+923336464238

CONTACTAthar Razzaq, FCPS

athar.razzaq@tih.org.pk+923007183545

PRINCIPAL_INVESTIGATORMuhammad Sarfraz, FCPS

Recep Tayyip Erdogan Hospital, Muzaffargarh

PRINCIPAL_INVESTIGATORAthar Razzaq, FCPS