Investigating the effect of vitamin E on the Treatment of Neonatal Hyperbilirubinemia
Phase 3
- Conditions
- eonatal Hyperbilirubinemia.Neonatal jaundice due to other excessive hemolysis
- Registration Number
- IRCT20220806055625N2
- Lead Sponsor
- Sanandaj University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Term infants with hyperbilirubinemia admitted to the neonatal department of Besat Sanandaj Hospital in 1401
Gestational age from 37 weeks to 42 weeks and 6 days
Birth weight from 2500 Grams to 4000 Grams
Exclusion Criteria
Evidence of infection
Congenital malformation
History of phenobarbital use in mother
Hypothyroidism
Inappropriate intrauterine growth
Oral intolerance
Mechanical ventilation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean serum total bilirubin. Timepoint: Serum total bilirubin 24 hours, 48 hours and 72 hours after intervention in two groups. Method of measurement: Taking blood samples from the infants in the study at 24 hours, 48 hours and 72 hours after the intervention by a trained nurse and sending them to the lab.;Mean serum indirect bilirubin. Timepoint: Serum indirect bilirubin 24 hours, 48 hours and 72 hours after intervention in two groups. Method of measurement: Taking blood samples from the infants in the study at 24 hours, 48 hours and 72 hours after the intervention by a trained nurse and sending them to the lab.;The amount of changes in the mean serum total bilirubin. Timepoint: Before the intervention and 24, 48 and 72 hours after the intervention. Method of measurement: Comparing the average total serum bilirubin before the intervention and the average total serum bilirubin obtained 24, 48 and 72 hours after the intervention.
- Secondary Outcome Measures
Name Time Method The average number of hospitalization days of newborns in two groups. Timepoint: Number of hospitalization days 24 hours, 48 hours and 72 hours after intervention in two groups. Method of measurement: Registration the number of hospitalization days of the newborns according to the file by a trained nurse.;The average hours of receiving phototherapy for newborns in two groups. Timepoint: Number of hours receiving phototherapy 24 hours, 48 hours and 72 hours after intervention in two groups. Method of measurement: Registering data of number of hours receiving phototherapy by a trained nurse.;Possible complications of vitamin E drug. Timepoint: 24 hours, 48 hours and 72 hours after the intervention in two groups. Method of measurement: A booklet containing the desired questions related to possible complications (these complications are selected by reviewing the literature) is provided to the mothers of babies and is followed up by a trained nurse.