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NCT04433923 Clinical Trial

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

Neonatal Jaundice Clinical Trial

Official title:
Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants: Randomised Control Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04433923
Other study ID # MansouraU004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2016
Est. completion date December 1, 2018

Study information
Verified date June 2020
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date December 1, 2018
Est. primary completion date December 1, 2018
Accepts healthy volunteers
Gender All
Age group N/A to 28 Days
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Phototherapy with aluminum foil

• Phototherapy without aluminum foil

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Outcome
Type Measure Description Time frame Safety issue
Primary Total serum bilirubin measurement of Total serum bilirubin (mg/dl) 8 hours of treatment
Primary Total serum bilirubin measurement of Total serum bilirubin (mg/dl) 24 hours of treatment
Primary Total serum bilirubin measurement of Total serum bilirubin (mg/dl) 48 hours of treatment
Secondary duration of photo therapy duration of photo therapy in hours average 48 hours
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