search
Back to results

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

Primary Purpose

Oxidative Stress, Neonatal Hyperbilirubinemia, Phototherapy Complication

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
phototherapy
Sponsored by
Rania Ali El-Farrash
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oxidative Stress

Eligibility Criteria

2 Days - 28 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    conventional phototherapy

    extensive phototherapy

    LED phototherapy

    Arm Description

    neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy

    neonates with unconjugated hyperbilirubinemia exposed to extensive phototherapy

    neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.

    Full Information

    First Posted
    February 16, 2017
    Last Updated
    March 7, 2017
    Sponsor
    Rania Ali El-Farrash
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03074292
    Brief Title
    Comparison Between Effect of Conventional, Intensive and Light Emitting Diodes (LED) Phototherapy on Oxidative Stress Among Neonates With Unconjugated Hyperbilirubinemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    March 2017 (Anticipated)
    Study Completion Date
    March 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Rania Ali El-Farrash

    4. Oversight

    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

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oxidative Stress, Neonatal Hyperbilirubinemia, Phototherapy Complication

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    conventional phototherapy
    Arm Type
    Active Comparator
    Arm Description
    neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy
    Arm Title
    extensive phototherapy
    Arm Type
    Active Comparator
    Arm Description
    neonates with unconjugated hyperbilirubinemia exposed to extensive phototherapy
    Arm Title
    LED phototherapy
    Arm Type
    Active Comparator
    Arm Description
    neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy
    Intervention Type
    Procedure
    Intervention Name(s)
    phototherapy
    Intervention Description
    estimate oxidative stress and trace elements in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy
    Primary Outcome Measure Information:
    Title
    Effect of types of phototherapy on change in total antioxidant capacity (TAC)
    Description
    This will be determined by: Measure TAC (mmol/L) before and after phototherapy Compare results of TAC (mmol/L) before and after phototherapy.
    Time Frame
    2 days
    Title
    Effect of types of phototherapy on change in malonaldehyde (MDA)
    Description
    This will be determined by: Measure MDA (nmol/L) before and after phototherapy Compare results of MDA (nmol/L) before and after phototherapy.
    Time Frame
    2 days
    Title
    Effect of types of phototherapy on change in nitric oxide (NO)
    Description
    This will be determined by: Measure NO (umol/L) before and after phototherapy Compare results of NO (umol/L) before and after phototherapy.
    Time Frame
    2 days
    Secondary Outcome Measure Information:
    Title
    Effect of types of phototherapy on change in serum iron (Fe)
    Description
    This will be determined by: Measure serum Fe before and after phototherapy Compare results of serum Fe before and after phototherapy.
    Time Frame
    2 days
    Title
    Effect of types of phototherapy on change in serum copper (Cu)
    Description
    This will be determined by: Measure serum Cu before and after phototherapy Compare results of serum Cu before and after phototherapy.
    Time Frame
    2 days
    Title
    Effect of types of phototherapy on change in serum zinc (Zn)
    Description
    This will be determined by: Measure serum Zn before and after phototherapy Compare results of serum Zn before and after phototherapy.
    Time Frame
    2 days
    Title
    Effect of types of phototherapy on change in serum calcium (Zn)
    Description
    This will be determined by: Measure serum Ca before and after phototherapy Compare results of serum Ca before and after phototherapy.
    Time Frame
    2 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Days
    Maximum Age & Unit of Time
    28 Days
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30458636
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs