L-carnitine for preterm babies with respiratory distress syndrome
Official title: Effect of L-Carnitine Supplementation in Preterm Neonates Suffering From Respiratory Distress Syndrome (RDS)
Run by RESnTEC, Institute of Research · NCT07437391 · Data updated 2026-11-12
This will see if giving L-carnitine to preterm babies with respiratory distress helps them gain weight, leave the hospital sooner, or survive the early newborn period.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Hour to 24 Hours |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | RESnTEC, Institute of Research Academic / other |
| Locations | 1 site (Muzaffargarh, Punjab Province) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | June 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT07437391 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Preterm neonates of either sex with respiratory distress syndrome admitted to the NICU within 24 hours of birth who do not have sepsis or gastrointestinal anomalies are the intended participants.
✕Probably not a fit
Infants with confirmed or suspected sepsis, congenital gastrointestinal tract anomalies, or those judged unlikely to survive beyond 48 hours are excluded and unlikely to benefit from the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study enrolls preterm neonates with respiratory distress syndrome who are admitted to the NICU within 24 hours of birth. Participants receive L-carnitine supplementation in addition to standard neonatal care and are compared with infants receiving standard care alone. Primary short-term outcomes include weight gain, hospital discharge rate, and early mortality, while safety and metabolic measures will also be monitored. Neonates with gastrointestinal anomalies, confirmed or suspected sepsis at enrollment, or an expected survival under 48 hours are excluded, and the trial is conducted at a single center in Muzaffargarh, Pakistan.
Why it matters
Potential benefit: If effective, L-carnitine could improve growth, increase discharge rates, and reduce early mortality in preterm infants with RDS.
How similar studies have gone: Previous small or heterogeneous studies on neonatal L-carnitine supplementation have reported mixed results, with some metabolic or growth benefits suggested but no clear consensus.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
-
Recep Tayyip Erdogan Hospital/Indus Hospital & Health Network
Muzaffargarh, Punjab Province, Pakistan Recruiting
Study contacts
- Principal investigator: Muhammad Sarfraz, FCPS — Recep Tayyip Erdogan Hospital, Muzaffargarh
- Study coordinator: Muhammad Sarfraz, FCPS
- Email: drfraz1986@gmail.com
- Phone: +923336464238
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.