Respiratory Distress SyndromeNCT07437391
Effect of L-Carnitine Supplementation in Preterm Neonates
A study testing L-carnitine in people with Respiratory Distress Syndrome, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 24 hours
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- L-carnitine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm neonates
- Either gender
- With RDS
- Admitted to the neonatal intensive care unit (NICU) within 24 hours of birth .
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Recep Tayyip Erdogan Hospital/Indus Hospital & Health Network
Muzaffargarh, Punjab Province, 32400
Muhammad Sarfraz, FCPS, +923336464238, drfraz1986@gmail.com
Athar Razzaq, PCPS, +923007183545, athar.razzaq@tih.org.pk
About this study
Official title: Effect of L-Carnitine Supplementation in Preterm Neonates Suffering From Respiratory Distress Syndrome (RDS)
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.
Read the 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.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- L-carnitine, Standard care
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: L-carnitine; Drug: 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. Receives: Drug: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
If a patient will die in the hospital, it will be considered as mortality, otherwise taken as discharged alive.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Muhammad Sarfraz, FCPS, Principal investigator, Recep Tayyip Erdogan Hospital, MuzaffargarhAthar Razzaq, FCPS, Principal investigator, Recep Tayyip Erdogan Hospital, Muzaffargarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437391
- Sponsor's protocol ID
- Dr-Sarfraz-DGK
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of L-Carnitine Supplementation in Preterm Neonates Suffering From Respiratory Distress Syndrome (RDS)
- ClinicalTrials.gov ID
- NCT07437391
- Acronym / sponsor ID
- Dr-Sarfraz-DGK
- Conditions
- Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-carnitine Group | Experimental | Drug: L-carnitine, Drug: Standard carePatients 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. |
| No L-carnitine Group | Experimental | Drug: Standard carePatients 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. |
Who may qualify
- Ages
- 1 hour to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm neonates
- Either gender
- With RDS
- Admitted to the neonatal intensive care unit (NICU) within 24 hours of birth .
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-carnitinePatients 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-carnitine Group |
| Standard carePatients 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. | Drug | L-carnitine Group, No L-carnitine Group |
Primary outcome
Mortality
Time frame: 30 days
If a patient will die in the hospital, it will be considered as mortality, otherwise taken as discharged alive.
Change in Weight
Time frame: 30 days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
Related trials for Respiratory Distress Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muhammad Sarfraz, FCPS principal investigator
Recep Tayyip Erdogan Hospital, Muzaffargarh
Athar Razzaq, FCPS principal investigator
Recep Tayyip Erdogan Hospital, Muzaffargarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-carnitine in people with Respiratory Distress Syndrome, run by Muhammad Aamir Latif at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Sarfraz, FCPS (+923336464238, drfraz1986@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.