Effect of L-Carnitine Supplementation in Preterm Neonates
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: L-carnitine, Standard care.
- Who it may be relevant to
- Registry conditions: Respiratory Distress Syndrome. Basic parameters: 1 Hour — 24 Hours · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of L-Carnitine Supplementation in Preterm Neonates Suffering From Respiratory Distress Syndrome (RDS)
Overview
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
- Drug L-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. - Drug Standard 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.
Primary outcome measures
- Mortality [Time frame: 30 days]
- Change in Weight [Time frame: 30 days]
Eligibility 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Recep Tayyip Erdogan Hospital/Indus Hospital & Health Network — Muzaffargarh
Identifiers
NCT: NCT07437391 · Dr-Sarfraz-DGK