evaluation of Melatonin effect on short outcome in newborns with hypoxic ischemic encephalopathy
Phase 2
Recruiting
- Conditions
- Hypoxic ischemic encephalopathy [HIE].Hypoxic ischemic encephalopathy [HIE]P91.6
- Registration Number
- IRCT20160523028008N19
- Lead Sponsor
- Hamedan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
At least one of diagnostic criteria of HIE include: 1-APGAR score <5 at 5 minutes
Fetal heart rate <60 bpm
Prolonged metabolic acidosis(>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
Gestational age <36weeks
Congenital anomalies
Unperforated anus
Intracranial hemorrhage
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Drug complications such as thrombocytopenia. Timepoint: From the beginning of the intervention up to two weeks late. Method of measurement: By laboratory tests.