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

Study Overview
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Brief Summary
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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.

Conditions
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Oxidative Stress, Neonatal Hyperbilirubinemia, Phototherapy Complication

Intervention / Treatment
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* Procedure: phototherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional phototherapy<br>neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy | Procedure: phototherapy<br>* estimate oxidative stress and trace elements in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy<br>|
| Active Comparator: extensive phototherapy<br>neonates with unconjugated hyperbilirubinemia exposed to extensive phototherapy | Procedure: phototherapy<br>* estimate oxidative stress and trace elements in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy<br>|
| Active Comparator: LED phototherapy<br>neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy | Procedure: phototherapy<br>* estimate oxidative stress and trace elements in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of types of phototherapy on change in serum iron (Fe) | This will be determined by: Measure serum Fe before and after phototherapy Compare results of serum Fe before and after phototherapy. | 2 days | 
| Effect of types of phototherapy on change in serum copper (Cu) | This will be determined by: Measure serum Cu before and after phototherapy Compare results of serum Cu before and after phototherapy. | 2 days | 
| Effect of types of phototherapy on change in serum zinc (Zn) | This will be determined by: Measure serum Zn before and after phototherapy Compare results of serum Zn before and after phototherapy. | 2 days | 
| Effect of types of phototherapy on change in serum calcium (Zn) | This will be determined by: Measure serum Ca before and after phototherapy Compare results of serum Ca before and after phototherapy. | 2 days |