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
About this trial
This is an interventional treatment trial for Neonatal Jaundice
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
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
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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