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

Not Applicable

Completed

• Conditions: Neonatal Jaundice
• Interventions: Device: Phototherapy without aluminum foil; Device: Phototherapy with aluminum foil

• Registration Number: NCT04433923
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-13
• Study First Submitted QC: 2020-06-13
• Last Update Submitted: 2020-06-13
• Study First Posted: 2020-06-16
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GROUP2	Phototherapy without aluminum foil	Phototherapy without aluminum foil
GROUP1	Phototherapy with aluminum foil	Phototherapy with aluminum foil

Primary Outcome Measures

Name	Time	Method
Total serum bilirubin	48 hours of treatment	measurement of Total serum bilirubin (mg/dl)

Secondary Outcome Measures

Name	Time	Method
duration of photo therapy	average 48 hours	duration of photo therapy in hours