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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2018-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Neonatal Jaundice

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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GROUP1

Phototherapy with aluminum foil

Group Type ACTIVE_COMPARATOR

Phototherapy with aluminum foil

Intervention Type DEVICE

GROUP2

Phototherapy without aluminum foil

Group Type PLACEBO_COMPARATOR

Phototherapy without aluminum foil

Intervention Type DEVICE

Interventions

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Phototherapy with aluminum foil

Intervention Type DEVICE

Phototherapy without aluminum foil

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No