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

Mansoura University

Status: Completed

Conditions: Neonatal Jaundice

Treatments: Device: Phototherapy with aluminum foil; Device: Phototherapy without aluminum foil

Study type: Interventional

Funder types: Other

Identifiers

NCT04433923

MansouraU004

Details and patient eligibility

About

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.

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups, including a placebo group

GROUP1

Active Comparator group

Description:

Phototherapy with aluminum foil

Treatment:

Device: Phototherapy with aluminum foil

GROUP2

Placebo Comparator group

Description:

Phototherapy without aluminum foil

Treatment:

Device: Phototherapy without aluminum foil