Evaluation of the effect of melatonin in the treatment of sepsis

The effect of melatonin on the course of treatment and complications of sepsis in infants

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210825052289N1

Enrollment

Registered

2021-09-14

Start date

2021-09-11

Completion date

Unknown

Last updated

2021-11-01

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

Conditions

sepsis in neonates. Bacterial sepsis of newborn, unspecified

Interventions

Intervention 1: Intervention group: Patients of this group will receive Melatonin tablet from Normlife Company every 12 hours for 3 days. Intervention 2: Control group: Patients of this group will not

Eligibility

Sex/Gender

All

Age

1 Days to 28 Days

Inclusion criteria

Inclusion criteria: Parental consent Infants under one month of age Diagnosis of sepsis according to clinical and laboratory criteria NPO patient(Non Pre Oral) absence of any underlying disease infants with gestational age above 37 weeks

Exclusion criteria

Exclusion criteria: Parental dissatisfaction Death of the patient during melatonin administration Existence of congenital anomalies Existence of severe sepsis Presence of congenital heart disease PO intolerance and frequent vomiting

Design outcomes

Primary

Measure	Time frame
White blood cell. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Acquiring venous blood sample.;C-Reactive Protein. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Acquiring venous blood sample.;Interleukin-6. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Acquiring venous blood sample.	—

Measure

Time frame

White blood cell. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Acquiring venous blood sample.;C-Reactive Protein. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Acquiring venous blood sample.;Interleukin-6. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Acquiring venous blood sample.

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Secondary

Measure	Time frame
Neonates general status. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Based on Attending's evaluation in 3 categories: Well, Ill and Toxic.;Poorfeeding. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Based on Attending's evaluation.;Outcome. Timepoint: Upon discharge. Method of measurement: Death or Living based on Attending's evaluation.;Length of hospital stay. Timepoint: Upon discharge. Method of measurement: Based on date's submitted to patient profile.	—

Measure

Time frame

Neonates general status. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Based on Attending's evaluation in 3 categories: Well, Ill and Toxic.;Poorfeeding. Timepoint: At the beginning of treatment and 3 days after treatment. Method of measurement: Based on Attending's evaluation.;Outcome. Timepoint: Upon discharge. Method of measurement: Death or Living based on Attending's evaluation.;Length of hospital stay. Timepoint: Upon discharge. Method of measurement: Based on date's submitted to patient profile.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactArmin Ghahremanzadeh

Ardabil University of Medical Sciences

Drarminghahreman@gmail.com+98 45 3325 2251

Outcome results

None listed

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