The effect of L-carnitine in neonates with sepsis admitted to NICU

The effect of L-carnitine compared to placebo on some inflammatory markers and disease course in infants with sepsis in the neonatal intensive care unit (NICU): a randomized, triple-blind, controlled clinical trial study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20221206056734N4

Enrollment

Registered

2025-05-27

Start date

2025-06-05

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonates with sepsis who are admitted to the NICU. Other sepsis

Interventions

Intervention 1: Intervention group: 18 sepsis neonates admitted to the NICU will receive 50 mg/kg of liquid oral L-carnitine, produced by Pars Behrouzan Jam Company, along with tube feeding for 7 days

Eligibility

Sex/Gender

All

Age

1 Days to 29 Days

Inclusion criteria

Inclusion criteria: Neonatal sepsis Neonates with sepsis are expected to stay in the NICU for more than 7 days Legal guardian's consent.

Exclusion criteria

Exclusion criteria: Having liver or kidney diseases that contraindicate L-carnitine use NPO patients who cannot start enteral nutrition Sensitivity to L-carnitine supplementation

Design outcomes

Primary

Measure	Time frame
Serum C-Reactive Protein (CRP). Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Blood test.;Serum neutrophil to lymphocyte ratio (NLR). Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Blood test.;Serum monocyte to lymphocyte ratio (MLR). Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Blood test.;Serum platelet-to-lymphocyte ratio (PLR). Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Blood test.	—

Measure

Time frame

Serum C-Reactive Protein (CRP). Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Blood test.;Serum neutrophil to lymphocyte ratio (NLR). Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Blood test.;Serum monocyte to lymphocyte ratio (MLR). Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Blood test.;Serum platelet-to-lymphocyte ratio (PLR). Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Blood test.

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Secondary

Measure	Time frame
Prognostic Nutritional Index (PNI). Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Based on total lymphocyte count and serum albumin concentration.;Prognostic Index. Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Based on serum C-reactive protein and serum white blood cell count.;Glasgow Prognostic Score (GCS). Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Based on C-reactive protein and serum albumin concentrations.	—

Measure

Time frame

Prognostic Nutritional Index (PNI). Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Based on total lymphocyte count and serum albumin concentration.;Prognostic Index. Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Based on serum C-reactive protein and serum white blood cell count.;Glasgow Prognostic Score (GCS). Timepoint: Before the start of the intervention and 7 days after the start of the intervention. Method of measurement: Based on C-reactive protein and serum albumin concentrations.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Behrooz

Tabriz University of Medical Sciences

mm.behrooz@gmail.com+98 41 3159 5050

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026