Investigating the effect of probiotics on neonatal jaundice

Phase 3

Recruiting

Conditions: eonatal hyperbilirubinemia.
Neonatal jaundice, unspecified
P59.9

Registration Number: IRCT20230816059167N1

Lead Sponsor: Kashan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 81

Inclusion Criteria

35 to 42 weeks of gestation
Birth weight between 10th and 90th percentile
Newborns aged from birth to 14 days
Hyperbilirubinemia based on Bhutani Nomogram

Exclusion Criteria

Unwillingness to cooperate (lack of parental consent)
Taking antibiotics
Any acute or active infection
Occurrence of any side effects
Not consuming breast milk exclusively
Thyroid disorders
Presence of respiratory distress
NICU admission
Congenital heart disease
The presence of hemolysis, hemoglobinopathies, and hemolytic blood diseases such as G6PD deficiency, blood group incompatibility
Cephal hematoma and subgaleal hemorrhage
Phenobarbital consumption by the mother in the last month of pregnancy
Non-physiological hyperbilirubinemia
Presence of a life-threatening congenital disorder
Blood exchange
Outpatient treatment

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Bilirubin. Timepoint: At the beginning of the study and 24, 48, 72 and 96 hours after the intervention. Method of measurement: Serum total bilirubin (mg/mL).;Direct Bilirubin. Timepoint: At the beginning of the study and 24, 48, 72 and 96 hours after the intervention. Method of measurement: Serum direct bilirubin (mg/mL).;Indirect Bilirubin. Timepoint: At the beginning of the study and 24, 48, 72 and 96 hours after the intervention. Method of measurement: Serum indirect bilirubin (mg/mL).

Secondary Outcome Measures

Name	Time	Method
ength of hospital stay. Timepoint: At the time of discharge. Method of measurement: Days.;Defecation. Timepoint: on a daily basis from the day the intervention started until 96 hours later. Method of measurement: Number of defecations per day.;Complications including allergic reactions, gastrointestinal complications and . Timepoint: on a daily basis from the day the intervention started until 96 hours later. Method of measurement: History taking and physical examination.