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Investigating the effect of vitamin E on the Treatment of Neonatal Hyperbilirubinemia

Comparison of the Effect of vitamin E Supplementation on the Treatment of Neonates with Hyperbilirubinemia: A Double-blind Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220806055625N2
Enrollment
70
Registered
2022-12-26
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-02-07

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

Conditions

Neonatal Hyperbilirubinemia. Neonatal jaundice due to other excessive hemolysis

Interventions

Intervention 1: Intervention group: 35 infants are placed in the group receiving vitamin E orally with a dose of 0/5 cc (equivalent to 10 drops) orally once a day, on the first, second and third days

Sponsors

Sanandaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 30 Days

Inclusion criteria

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

Exclusion criteria: Evidence of infection Congenital malformation History of phenobarbital use in mother Hypothyroidism Inappropriate intrauterine growth Oral intolerance Mechanical ventilation

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSirous Hematpour

Sanandaj University of Medical Sciences

Dr.siroshematour@yahoo.com+98 87 3322 9494

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 6, 2026