evaluation of Melatonin effect on short outcome in newborns with hypoxic ischemic encephalopathy

The evaluation of Melatonin effect on short outcome in newborns with hypoxic ischemic encephalopathy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160523028008N19

Enrollment

Registered

2021-12-06

Start date

2021-12-21

Completion date

Unknown

Last updated

2022-01-11

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

Conditions

Hypoxic ischemic encephalopathy [HIE]. Hypoxic ischemic encephalopathy [HIE]

Interventions

Intervention 1: Intervention group: Routine treatment plus intravenous injection of melatonin 1O mg/kgday on the first, second and third days and then every other day on the fifth, seventh, and ninth

Eligibility

Sex/Gender

All

Age

1 Days to 28 Days

Inclusion criteria

Inclusion criteria: At least one of diagnostic criteria of HIE include: 1-APGAR score 1 hour) Need of positive pressure ventilation>1 min or delay in crying >10 min of birth Occurrence of acute perinatal events Exclusion criteria Seizures occur in the first 24 to 48 hours after birth

Exclusion criteria

Exclusion criteria: Gestational age <36weeks Congenital anomalies Unperforated anus Intracranial hemorrhage

Design outcomes

Primary

Measure	Time frame
Seizure attacks. Timepoint: From the beginning of the intervention until two weeks thereafter. Method of measurement: With clinical examination.;Time of onset of consciousness. Timepoint: From the beginning of the intervention until two weeks thereafter. Method of measurement: With clinical examination.;Occurrence of death. Timepoint: From the beginning of the intervention until two weeks thereafter. Method of measurement: With clinical examination.;Duration of hospitalization. Timepoint: From the beginning of the intervention until two weeks thereafter. Method of measurement: Based on the medical document.;Drug complications such as induced topical hypothermia, bradycardia and subcutaneous necrosis. Timepoint: From the beginning of the intervention until two weeks thereafter. Method of measurement: With clinical examination.;Time to start oral nutrition. Timepoint: From the beginning of the intervention until two weeks thereafter. Method of measurement: By taking a history.	—

Measure

Time frame

Seizure attacks. Timepoint: From the beginning of the intervention until two weeks thereafter. Method of measurement: With clinical examination.;Time of onset of consciousness. Timepoint: From the beginning of the intervention until two weeks thereafter. Method of measurement: With clinical examination.;Occurrence of death. Timepoint: From the beginning of the intervention until two weeks thereafter. Method of measurement: With clinical examination.;Duration of hospitalization. Timepoint: From the beginning of the intervention until two weeks thereafter. Method of measurement: Based on the medical document.;Drug complications such as induced topical hypothermia, bradycardia and subcutaneous necrosis. Timepoint: From the beginning of the intervention until two weeks thereafter. Method of measurement: With clinical examination.;Time to start oral nutrition. Timepoint: From the beginning of the intervention until two weeks thereafter. Method of measurement: By taking a history.

—

Secondary

Measure	Time frame
Drug complications such as thrombocytopenia. Timepoint: From the beginning of the intervention up to two weeks late. Method of measurement: By laboratory tests.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNahid Kiani

Hamedan University of Medical Sciences

NahidKiani65@yahoo.com+98 917 332 4977

Outcome results

None listed

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