Comparison Between Effect of Conventional, Intensive and Light Emitting Diodes (LED) Phototherapy on Oxidative Stress Among Neonates With Unconjugated Hyperbilirubinemia

Rania Ali El-Farrash

Status: Unknown

Conditions: Phototherapy Complication; Neonatal Hyperbilirubinemia; Oxidative Stress

Treatments: Procedure: phototherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03074292

00006444

Details and patient eligibility

About

The aim of the present study is to test a hypothesis assuming that phototherapy might have an effect on oxidant/antioxidant status in term and late-preterm neonates with unconjugated hyperbilirubinemia.

Enrollment: 120 patients

Sex: All

Ages: 2 to 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Term and late-preterm neonates (≥35weeks) according to the guidelines of the American Academy of Pediatrics (2004) which stated that gestational ages of newborns were determined according to the first day of the mother's last menstrual period (by the mother's statement) and were additionally confirmed by the Ballard scoring system (Ballard et al., 1991) and antenatal ultrasonographic estimation or obstetric records if present.
• Clinical significant indirect hyperbilirubinemia requiring phototherapy in the first week of life.
• Normal blood counts and peripheral blood smears
• Normal reticulocytic count.
• Breast fed newborn.

Exclusion criteria

• Those in whom the total serum bilirubin (TSB) level rose by more than 5 mg/dl per day or was higher than 20 mg/dl within the first 24 hours after birth were excluded from the study.
• Infant of diabetic mothers.
• Maternal eclampsia-preeclampsia.
• Birth asphyxia
• Sepsis
• congenital anomalies.
• Direct Coombs'test positive
• Pathological causes of hyperbilirubinemia.
• Enclosed hemorrhage.
• Hemolytic type of hyperbilirubinemia due to blood group or Rh incompatibility.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

conventional phototherapy

Active Comparator group

Description:

neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy

Treatment:

Procedure: phototherapy

extensive phototherapy

Active Comparator group

Description:

neonates with unconjugated hyperbilirubinemia exposed to extensive phototherapy

Treatment:

Procedure: phototherapy

LED phototherapy

Active Comparator group

Description:

neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy

Treatment:

Procedure: phototherapy