Effect of L-Carnitine Supplementation in Preterm Neonates

ConditionRespiratory Distress Syndrome

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age1-24

SponsorMuhammad Aamir Latif

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Preterm neonates

Either gender

With RDS

Admitted to the neonatal intensive care unit (NICU) within 24 hours of birth .

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

L-carnitine
Drug
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.
Standard care
Drug
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.

Treatment groups

160 Participants

are divided into 2 treatment groups

Group A: L-carnitine GroupExperimental treatment 2 interventions

Group B: No L-carnitine GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Mortality

If a patient will die in the hospital, it will be considered as mortality, otherwise taken as discharged alive.

Time frame

30 days

Change in Weight

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.

Time frame

30 days

Sponsors and contacts

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Muhammad Aamir Latif

Lead sponsor

RESnTEC, Institute of Research

Sponsor institution

Source ClinicalTrials.gov

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