NCT04433923

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

2.5 years

First QC Date

June 13, 2020

Last Update Submit

June 13, 2020

Conditions

Neonatal Jaundice

Outcome Measures

Primary Outcomes (3)

  • Total serum bilirubin

    measurement of Total serum bilirubin (mg/dl)

    8 hours of treatment

  • Total serum bilirubin

    measurement of Total serum bilirubin (mg/dl)

    24 hours of treatment

  • Total serum bilirubin

    measurement of Total serum bilirubin (mg/dl)

    48 hours of treatment

Secondary Outcomes (1)

  • duration of photo therapy

    average 48 hours

Study Arms (2)

GROUP1

ACTIVE COMPARATOR

Phototherapy with aluminum foil

Device: Phototherapy with aluminum foil

GROUP2

PLACEBO COMPARATOR

Phototherapy without aluminum foil

Device: Phototherapy without aluminum foil

Interventions

Phototherapy with aluminum foilDEVICE
GROUP1
Phototherapy without aluminum foilDEVICE
GROUP2

Eligibility Criteria

AgeUp to 28 Days
Sexall
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Preterm infants, newborn infant with congenital malformations, conjugated hyperbilirubinamia, small for gestational age, in need of exchange transfusion, and skin abrasions or infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Jaundice, Neonatal

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, NeonatalInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2020

First Posted

June 16, 2020

Study Start

June 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

June 16, 2020

Record last verified: 2020-06