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

June 13, 2020 updated by: Abd Elazeez Attala Shabaan, Mansoura University

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

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.

Study Overview

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GROUP1
Phototherapy with aluminum foil
Placebo Comparator: GROUP2
Phototherapy without aluminum foil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total serum bilirubin
Time Frame: 8 hours of treatment
measurement of Total serum bilirubin (mg/dl)
8 hours of treatment
Total serum bilirubin
Time Frame: 24 hours of treatment
measurement of Total serum bilirubin (mg/dl)
24 hours of treatment
Total serum bilirubin
Time Frame: 48 hours of treatment
measurement of Total serum bilirubin (mg/dl)
48 hours of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of photo therapy
Time Frame: average 48 hours
duration of photo therapy in hours
average 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

June 13, 2020

First Submitted That Met QC Criteria

June 13, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 13, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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