NCT07437391

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jan 2026Jun 2026

Study Start

First participant enrolled

January 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 18, 2026

Last Update Submit

February 23, 2026

Conditions

Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (2)

  • Mortality

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

    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.

    30 days

Study Arms (2)

L-carnitine Group

EXPERIMENTAL

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: L-carnitineDrug: Standard care

No L-carnitine Group

EXPERIMENTAL

Patients will get only 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

Interventions

L-carnitineDRUG

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.

L-carnitine Group
Standard careDRUG

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.

L-carnitine GroupNo L-carnitine Group

Eligibility Criteria

Age1 Hour - 24 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm neonates
  • Either gender
  • With RDS
  • Admitted to the neonatal intensive care unit (NICU) within 24 hours of birth .

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan Hospital/Indus Hospital & Health Network

Muzaffargarh, Punjab Province, 32400, Pakistan

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

CarnitineStandard of Care

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Muhammad Sarfraz, FCPS

    Recep Tayyip Erdogan Hospital, Muzaffargarh

    PRINCIPAL INVESTIGATOR

  • Athar Razzaq, FCPS

    Recep Tayyip Erdogan Hospital, Muzaffargarh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Sarfraz, FCPS

CONTACT

+923336464238drfraz1986@gmail.com

Athar Razzaq, FCPS

CONTACT

+923007183545athar.razzaq@tih.org.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Consultant

Study Record Dates

First Submitted

February 18, 2026

First Posted

February 27, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Data can be shared on a reasonable request.

Locations

PA(1)