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

March 7, 2017 updated by: Rania Ali El-Farrash
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days to 4 weeks (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: conventional phototherapy
neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy
Procedure: phototherapy
estimate oxidative stress and trace elements in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy
ACTIVE_COMPARATOR: LED phototherapy
neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy
Procedure: phototherapy
estimate oxidative stress and trace elements in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy
ACTIVE_COMPARATOR: extensive phototherapy
neonates with unconjugated hyperbilirubinemia exposed to extensive phototherapy
Procedure: phototherapy
estimate oxidative stress and trace elements in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 days
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.
2 days
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.
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of types of phototherapy on change in serum iron (Fe)
Time Frame: 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.
2 days
Effect of types of phototherapy on change in serum copper (Cu)
Time Frame: 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.
2 days
Effect of types of phototherapy on change in serum zinc (Zn)
Time Frame: 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.
2 days
Effect of types of phototherapy on change in serum calcium (Zn)
Time Frame: 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.
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rania Ali El-Farrash

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ANTICIPATED)

March 1, 2017

Study Completion (ANTICIPATED)

March 1, 2017

Study Registration Dates

First Submitted

February 16, 2017

First Submitted That Met QC Criteria

March 7, 2017

First Posted (ACTUAL)

March 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 8, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00006444

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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