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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04433923
Enrollment
Unknown
Registered
2020-06-16
Start date
2016-06-01
Completion date
2018-12-01
Last updated
2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Jaundice

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.

Interventions

DEVICEPhototherapy with aluminum foil
DEVICEPhototherapy without aluminum foil

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
No minimum to 28 Days

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

Design outcomes

Primary

MeasureTime frameDescription
Total serum bilirubin8 hours of treatmentmeasurement of Total serum bilirubin (mg/dl)

Secondary

MeasureTime frameDescription
duration of photo therapyaverage 48 hoursduration of photo therapy in hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026