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

Not Applicable

• Conditions: Neonatal Hyperbilirubinemia; Oxidative Stress; Phototherapy Complication
• Interventions: Procedure: phototherapy

• Registration Number: NCT03074292
• Lead Sponsor: Rania Ali El-Farrash

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2017-02-16
• Status Verified: 2017-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Study First Submitted QC: 2017-03-07
• Last Update Submitted: 2017-03-07
• Study First Posted: 2017-03-08
• Last Update Posted: 2017-03-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
conventional phototherapy	phototherapy	neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy
extensive phototherapy	phototherapy	neonates with unconjugated hyperbilirubinemia exposed to extensive phototherapy
LED phototherapy	phototherapy	neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy

Primary Outcome Measures

Name	Time	Method
Effect of types of phototherapy on change in malonaldehyde (MDA)	2 days	This will be determined by: 1. Measure MDA (nmol/L) before and after phototherapy; 2. Compare results of MDA (nmol/L) before and after phototherapy.
Effect of types of phototherapy on change in total antioxidant capacity (TAC)	2 days	This will be determined by: 1. Measure TAC (mmol/L) before and after phototherapy; 2. Compare results of TAC (mmol/L) before and after phototherapy.
Effect of types of phototherapy on change in nitric oxide (NO)	2 days	This will be determined by: 1. Measure NO (umol/L) before and after phototherapy; 2. Compare results of NO (umol/L) before and after phototherapy.

Secondary Outcome Measures

Name	Time	Method
Effect of types of phototherapy on change in serum iron (Fe)	2 days	This will be determined by: 1. Measure serum Fe before and after phototherapy; 2. Compare results of serum Fe before and after phototherapy.
Effect of types of phototherapy on change in serum calcium (Zn)	2 days	This will be determined by: 1. Measure serum Ca before and after phototherapy; 2. Compare results of serum Ca before and after phototherapy.
Effect of types of phototherapy on change in serum zinc (Zn)	2 days	This will be determined by: 1. Measure serum Zn before and after phototherapy; 2. Compare results of serum Zn before and after phototherapy.
Effect of types of phototherapy on change in serum copper (Cu)	2 days	This will be determined by: 1. Measure serum Cu before and after phototherapy; 2. Compare results of serum Cu before and after phototherapy.