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Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants

Primary Purpose

Neonatal Jaundice

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Phototherapy with aluminum foil
Phototherapy without aluminum foil
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Jaundice

Eligibility Criteria

undefined - 28 Days (Child)All Sexes

Inclusion Criteria:

  • Appropriate for gestational age full-term infants with pathological unconjugated hyperbilirubinaemia who are candidate for photo therapy according to American academy guidelines

Exclusion Criteria:

  • Preterm infants, newborn infant with congenital malformations, conjugated hyperbilirubinamia, small for gestational age, in need of exchange transfusion, and skin abrasions or infections

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    GROUP1

    GROUP2

    Arm Description

    Phototherapy with aluminum foil

    Phototherapy without aluminum foil

    Outcomes

    Primary Outcome Measures

    Total serum bilirubin
    measurement of Total serum bilirubin (mg/dl)
    Total serum bilirubin
    measurement of Total serum bilirubin (mg/dl)
    Total serum bilirubin
    measurement of Total serum bilirubin (mg/dl)

    Secondary Outcome Measures

    duration of photo therapy
    duration of photo therapy in hours

    Full Information

    First Posted
    June 13, 2020
    Last Updated
    June 13, 2020
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04433923
    Brief Title
    Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants
    Official Title
    Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants: Randomised Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2016 (undefined)
    Primary Completion Date
    December 1, 2018 (Actual)
    Study Completion Date
    December 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No

    5. Study Description

    Brief Summary
    prospective single center pilot randomized open label clinical trial, conducted at the Neonatal care unit of Mansoura University Children's To assess the efficacy and safety of aluminum foil use in combination with phototherapy compared with phototherapy alone for pathological unconjugated hyperbilirubinaemia in full term newborn We enrolled 234 infants in the study who fulfilled the inclusion criteria and were randomly assigned to treatment groups, either conventional phototherapy with aluminum foil or conventional phototherapy alone.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neonatal Jaundice

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable

    8. Arms, Groups, and Interventions

    Arm Title
    GROUP1
    Arm Type
    Active Comparator
    Arm Description
    Phototherapy with aluminum foil
    Arm Title
    GROUP2
    Arm Type
    Placebo Comparator
    Arm Description
    Phototherapy without aluminum foil
    Intervention Type
    Device
    Intervention Name(s)
    Phototherapy with aluminum foil
    Intervention Type
    Device
    Intervention Name(s)
    Phototherapy without aluminum foil
    Primary Outcome Measure Information:
    Title
    Total serum bilirubin
    Description
    measurement of Total serum bilirubin (mg/dl)
    Time Frame
    8 hours of treatment
    Title
    Total serum bilirubin
    Description
    measurement of Total serum bilirubin (mg/dl)
    Time Frame
    24 hours of treatment
    Title
    Total serum bilirubin
    Description
    measurement of Total serum bilirubin (mg/dl)
    Time Frame
    48 hours of treatment
    Secondary Outcome Measure Information:
    Title
    duration of photo therapy
    Description
    duration of photo therapy in hours
    Time Frame
    average 48 hours

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    28 Days
    Eligibility Criteria
    Inclusion Criteria: Appropriate for gestational age full-term infants with pathological unconjugated hyperbilirubinaemia who are candidate for photo therapy according to American academy guidelines Exclusion Criteria: Preterm infants, newborn infant with congenital malformations, conjugated hyperbilirubinamia, small for gestational age, in need of exchange transfusion, and skin abrasions or infections

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants

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