Skip to main content
OpenTrials
Completed

NCT Number: NCT04433923

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neonatal Jaundice Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Jaundice, Neonatal Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phototherapy with aluminum foil

Device

Phototherapy without aluminum foil

Device

Primary outcomes

  1. Total serum bilirubin

    Time frame: 8 hours of treatment

    measurement of Total serum bilirubin (mg/dl)

  2. Total serum bilirubin

    Time frame: 24 hours of treatment

    measurement of Total serum bilirubin (mg/dl)

  3. Total serum bilirubin

    Time frame: 48 hours of treatment

    measurement of Total serum bilirubin (mg/dl)

Secondary outcomes

  1. duration of photo therapy

    Time frame: average 48 hours

    duration of photo therapy in hours

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 16, 2020
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.