L-carnitine for preterm babies with respiratory distress syndrome
Effect of L-Carnitine Supplementation in Preterm Neonates Suffering From Respiratory Distress Syndrome (RDS)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 1 Hour to 24 Hours |
| Sex | All |
| Sponsor | RESnTEC, Institute of Research Academic / other |
| Locations | 1 site (Muzaffargarh, Punjab Province) |
| Trial ID | NCT07437391 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Muzaffargarh, Punjab Province
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.