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Effect of L-Carnitine Supplementation in Preterm Neonates

Plain-language guide to NCT07437391: not phased randomized trial of L-Carnitine, 160 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07437391
Phase
not phased
Status
recruiting participants
Start
2026-01-01
Completion (planned or actual)
2026-06-30
Participants
160 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Respiratory Distress Syndrome
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested L-Carnitine.

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.

It had two arms (groups): L-carnitine Group (experimental) and No L-carnitine Group (experimental).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 160 planned participants were the target.

It was open to people of any sex aged from 1 Hour up to 24 Hours.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Admitted to the neonatal intensive care unit (NICU) within 24 hours of birth .

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: 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).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

The L-Carnitine group and the comparison group ran side by side rather than switching.

Being open-label, the L-Carnitine study did not mask who received what.

It started in 2026-01-01 with completion listed for 2026-06-30.

It ran at 1 site in Pakistan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mortality (time frame: 30 days). Change in Weight (time frame: 30 days).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 160 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.

Our Notes on the Compound

L-Carnitine: An amino acid derivative that carries fatty acids into mitochondria for energy production.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.