Status unknownNCT03074292Updated Mar 8, 2017

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

An interventional study of phototherapy in Oxidative Stress, Neonatal Hyperbilirubinemia and Phototherapy Complication, sponsored by Rania Ali El-Farrash. Status unknown. Open to participants aged 2 Days to 28 Days. Per ClinicalTrials.gov, last updated 2017-03-08.

Sponsored by Rania Ali El-Farrash · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 120
Allocation: Randomized
Ages: 2 Days to 28 Days
Sex: All

Study 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.

Conditions studied

Oxidative Stress
Neonatal Hyperbilirubinemia
Phototherapy Complication

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Hyperbilirubinemia, Neonatal 96

In context

Hyperbilirubinemia, Neonatal

96 studies on the registry are indexed under Hyperbilirubinemia, Neonatal; 20 are open to participants now.

This study's enrollment of 120 is above the median of 100 across 61 interventional studies indexed under Hyperbilirubinemia, Neonatal.

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Lead sponsor

Rania Ali El-Farrash is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Days to 28 Days
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Those in whom the total serum (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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial assignment
Masking: None (open label)
Enrollment: 120 participants (actual)

Study arms

Active comparator
conventional phototherapy
neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy
Procedure: phototherapy
Active comparator
extensive phototherapy
neonates with unconjugated hyperbilirubinemia exposed to extensive phototherapy
Procedure: phototherapy
Active comparator
LED phototherapy
neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy
Procedure: phototherapy

Interventions

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

What researchers measure

Primary outcomes

Effect of types of phototherapy on change in total antioxidant capacity (TAC)
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.
Time frame: 2 days
Effect of types of phototherapy on change in malonaldehyde (MDA)
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.
Time frame: 2 days
Effect of types of phototherapy on change in nitric oxide (NO)
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.
Time frame: 2 days

Secondary outcomes

Effect of types of phototherapy on change in serum iron (Fe)
This will be determined by: 1. Measure serum Fe before and after phototherapy 2. Compare results of serum Fe before and after phototherapy.
Time frame: 2 days
Effect of types of phototherapy on change in serum copper (Cu)
This will be determined by: 1. Measure serum Cu before and after phototherapy 2. Compare results of serum Cu before and after phototherapy.
Time frame: 2 days
Effect of types of phototherapy on change in serum zinc (Zn)
This will be determined by: 1. Measure serum Zn before and after phototherapy 2. Compare results of serum Zn before and after phototherapy.
Time frame: 2 days
Effect of types of phototherapy on change in serum calcium (Zn)
This will be determined by: 1. Measure serum Ca before and after phototherapy 2. Compare results of serum Ca before and after phototherapy.
Time frame: 2 days

Study locations

No study locations are listed for this record.

References and documents

Publications

El-Farrash RA, El-Shimy MS, Tawfik S, Nada AS, Salem DAD, M Gallo MS, Abd-Elmohsen EW. Effect of phototherapy on oxidant/antioxidant status: a randomized controlled trial. Free Radic Res. 2019 Feb;53(2):179-186. doi: 10.1080/10715762.2018.1549364. Epub 2019 Mar 1. PubMed 30458636 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03074292
Lead sponsor: Rania Ali El-Farrash
Responsible party: Rania Ali El-Farrash (Assistant professor, Ain Shams University) — Sponsor-investigator
First posted: Mar 8, 2017
Start date: Dec 2013
Primary completion: Mar 2017 (estimated)
Completion: Mar 2017 (estimated)
Last update: Mar 8, 2017

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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