Investigation of the effect of oral ursodeoxycholic acid drug in neonatal jaundice

Phase 4

Recruiting

Conditions: Infant hyperbilirubinemia.
Disorders of porphyrin and bilirubin metabolism

Registration Number: IRCT20130313012803N3

Lead Sponsor: Rasht University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 106

Inclusion Criteria

parents' complete satisfaction with the presence of infants in the study
infants aged 3 to 10 days
birth weight: 2500 to 4000 grams
exclusive breastfeeding
gestational age: 37 to 41 weeks
total bilirubin 14 to 20 and direct is less than 1 mg/dl

Exclusion Criteria

history of any neurological disease
children with a history of seizures
electrolyte imbalance related to chronic disease (measured by blood test), direct hyperbilirubinemia (measured by blood test)
septicemia,
diseases leading to hyperbilirubinemia (Crigler-Najjar syndrome, Gilbert syndrome, hyperthyroid, hypothyroid, liver diseases)
babies with jaundice without ABO and Rh incompatibility and G6PDD
receiving IVIG
preterm infants
babies of diabetic mothers
obstruction of the bile ducts
babies who have 2 or more of the mentioned risk factors at once

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bilirubin level. Timepoint: The studied infants are checked for hyperbilirubinemia upon arrival and then at least once every 12-24 hours with a serum sample. Method of measurement: BT3500 device and photometric method using 2 and 4 dichloroaniline (DCA).

Secondary Outcome Measures

Name	Time	Method
Duration of hospitalization. Timepoint: During the period of hospitalization of the infant, the pediatric resident visits her every 8 hours and examines her for possible complications. Method of measurement: Examination by the pediatric resident.;Drug side effects. Timepoint: During the period of hospitalization of the infant, the pediatric resident visits her every 8 hours and examines her for possible complications. Method of measurement: Examination by the pediatric resident.