NCT03074292

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
Last Updated

March 8, 2017

Status Verified

March 1, 2017

Enrollment Period

3.2 years

First QC Date

February 16, 2017

Last Update Submit

March 7, 2017

Conditions

Oxidative StressNeonatal HyperbilirubinemiaPhototherapy Complication

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    2 days

Secondary Outcomes (4)

  • Effect of types of phototherapy on change in serum iron (Fe)

    2 days

  • Effect of types of phototherapy on change in serum copper (Cu)

    2 days

  • Effect of types of phototherapy on change in serum zinc (Zn)

    2 days

  • Effect of types of phototherapy on change in serum calcium (Zn)

    2 days

Study Arms (3)

conventional phototherapy

ACTIVE COMPARATOR

neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy

Procedure: phototherapy

extensive phototherapy

ACTIVE COMPARATOR

neonates with unconjugated hyperbilirubinemia exposed to extensive phototherapy

Procedure: phototherapy

LED phototherapy

ACTIVE COMPARATOR

neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy

Procedure: phototherapy

Interventions

phototherapyPROCEDURE

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

LED phototherapyconventional phototherapyextensive phototherapy

Eligibility Criteria

Age2 Days - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30458636DERIVED

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 16, 2017

First Posted

March 8, 2017

Study Start

December 1, 2013

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 8, 2017

Record last verified: 2017-03