Comparison Between Effect of Conventional, Intensive and Light Emitting Diodes (LED) Phototherapy on Oxidative Stress Among Neonates With Unconjugated Hyperbilirubinemia
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 120
- Primary Endpoint
- Effect of types of phototherapy on change in malonaldehyde (MDA)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Days to 28 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
conventional phototherapy
neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy
Intervention: phototherapy (Procedure)
extensive phototherapy
neonates with unconjugated hyperbilirubinemia exposed to extensive phototherapy
Intervention: phototherapy (Procedure)
LED phototherapy
neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy
Intervention: phototherapy (Procedure)
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)
Investigators
Rania Ali El-Farrash
Assistant professor
Ain Shams University