Neonatal Jaundice Clinical Trial
Official title:
Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants: Randomised Control Trial
Verified date | June 2020 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | December 1, 2018 |
Est. primary completion date | December 1, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A to 28 Days |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Mansoura University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total serum bilirubin | measurement of Total serum bilirubin (mg/dl) | 8 hours of treatment | |
Primary | Total serum bilirubin | measurement of Total serum bilirubin (mg/dl) | 24 hours of treatment | |
Primary | Total serum bilirubin | measurement of Total serum bilirubin (mg/dl) | 48 hours of treatment | |
Secondary | duration of photo therapy | duration of photo therapy in hours | average 48 hours |
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