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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Sarfraz, FCPS | Contact | +923336464238 | drfraz1986@gmail.com | |
| Athar Razzaq, FCPS | Contact | +923007183545 | athar.razzaq@tih.org.pk |
| Name | Affiliation | Role |
|---|---|---|
| Muhammad Sarfraz, FCPS | Recep Tayyip Erdogan Hospital, Muzaffargarh | Principal Investigator |
| Athar Razzaq, FCPS | Recep Tayyip Erdogan Hospital, Muzaffargarh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recep Tayyip Erdogan Hospital/Indus Hospital & Health Network | Recruiting | Muzaffargarh | Punjab Province | 32400 | Pakistan |
Data can be shared on a reasonable request.
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| 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. |
|
| D019984 |
| Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |