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Clinical Trials/NCT03074292
NCT03074292
Unknown
Not Applicable

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

Rania Ali El-Farrash0 sites120 target enrollmentDecember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oxidative Stress
Sponsor
Rania Ali El-Farrash
Enrollment
120
Primary Endpoint
Effect of types of phototherapy on change in malonaldehyde (MDA)
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
March 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Rania Ali El-Farrash
Responsible Party
Sponsor Investigator
Principal Investigator

Rania Ali El-Farrash

Assistant professor

Ain Shams University

Eligibility Criteria

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
  • congenital anomalies.
  • Direct Coombs'test positive
  • Pathological causes of hyperbilirubinemia.
  • Enclosed hemorrhage.
  • Hemolytic type of hyperbilirubinemia due to blood group or Rh incompatibility.

Outcomes

Primary Outcomes

Effect of types of phototherapy on change in malonaldehyde (MDA)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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 Outcomes

  • Effect of types of phototherapy on change in serum iron (Fe)(2 days)
  • Effect of types of phototherapy on change in serum calcium (Zn)(2 days)
  • Effect of types of phototherapy on change in serum zinc (Zn)(2 days)
  • Effect of types of phototherapy on change in serum copper (Cu)(2 days)

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