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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-03-31

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.

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Detailed Description

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Conditions

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Oxidative Stress Neonatal Hyperbilirubinemia Phototherapy Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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conventional phototherapy

neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy

Group Type ACTIVE_COMPARATOR

phototherapy

Intervention Type PROCEDURE

estimate oxidative stress and trace elements in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy

extensive phototherapy

neonates with unconjugated hyperbilirubinemia exposed to extensive phototherapy

Group Type ACTIVE_COMPARATOR

phototherapy

Intervention Type PROCEDURE

estimate oxidative stress and trace elements in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy

LED phototherapy

neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy

Group Type ACTIVE_COMPARATOR

phototherapy

Intervention Type PROCEDURE

estimate oxidative stress and trace elements in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy

Interventions

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phototherapy

estimate oxidative stress and trace elements in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy

Intervention Type PROCEDURE

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.

Minimum Eligible Age

2 Days

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No