Actively Recruiting

Phase Not Applicable
Age: 1Hour - 24Hours
All Genders
ID07437391

Effect of L-Carnitine Supplementation in Preterm Neonates Suffering From Respiratory Distress Syndrome (RDS)

Led by Muhammad Aamir Latif · Updated on 2026-02-27

160

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effects of L-carnitine supplementation in preterm newborns with Respiratory Distress Syndrome (RDS). The trial aims to clarify how L-carnitine influences short-term outcomes like weight gain, discharge rates, and survival, especially given conflicting data and lack of evidence among the local population. This research focuses on neonates who may be deficient in L-carnitine and seeks to address their metabolic needs. Participants are randomly assigned to one of two groups. One group receives L-carnitine at 30 mg/kg/day alongside a standard care regimen consisting of 100 mg phospholipids per kg of birth weight, divided into four doses. The other group receives only the standard care regimen without L-carnitine. Both treatments are given during their stay in the neonatal intensive care unit. During the study, the babies' health is closely monitored, including their weight changes and survival status over 30 days. Researchers will assess how L-carnitine supplementation affects these outcomes compared to standard care alone. The study is designed to provide evidence on the safety and potential benefits of adding L-carnitine for managing preterm neonates with RDS, with participation lasting at least 30 days post-treatment.

CONDITIONS

Brief Title

Effect of L-Carnitine Supplementation in Preterm Neonates

Who Can Participate

Age: 1Hour - 24Hours
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm neonates
  • Any gender
  • Diagnosed with Respiratory Distress Syndrome (RDS)
  • Admitted to the neonatal intensive care unit (NICU) within 24 hours of birth
Not Eligible

You will not qualify if you...

  • Neonates with gastrointestinal tract anomalies
  • Neonates with confirmed or suspected sepsis at enrollment
  • Neonates expected to survive less than 48 hours as judged by a neonatologist

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 30 days

Participants receive either L-carnitine supplementation along with standard care or standard care alone to manage Respiratory Distress Syndrome.

Daily treatment visits during hospital stay

Trial Site Locations

Total: 1 location

1

Recep Tayyip Erdogan Hospital/Indus Hospital & Health Network

Muzaffargarh, Punjab Province, Pakistan, 32400

Actively Recruiting

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Research Team

M

Muhammad Sarfraz, FCPS

A

Athar Razzaq, FCPS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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