Neonatal Hyperbilirubinemia Clinical Trial
Official title:
Conventional Versus LED Phototherapy and Their Effect on Lymphocytes Subsets of Full Term Neonates With Hyperbilirubinemia
Verified date | April 2020 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to investigate the influence of the use of different types of phototherapy on different lymphocytes subsets CD4 and CD8 in the treatment of hyperbilirubinemia in neonates.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 1, 2020 |
Est. primary completion date | July 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 28 Days |
Eligibility |
Inclusion Criteria: Term neonates with a gestational week higher than 37weeks, according to the guidelines of the American Academy of Pediatrics (2004) which stated that gestational ages of newborns are determined according to the first day of the mother's last menstrual period (by the mother's statement) and were additionally confirmed by the Ballard scoring system (Ballard et al., 1991) and antenatal ultrasonographic estimation or obstetric records if present. - Clinically significant indirect hyperbilirubinemia requiring phototherapy in the first week of life. - No pathologic etiological factors for hyperbilirubinemia Exclusion Criteria: - Total bilirubin level of >20 mg/dl. - Prematurity. - Sepsis. - Congenital anomaly. - Elevation in direct bilirubin level. - History of immune deficiency the family. - History of preeclampsia or any other diseases or drug use of the mother |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Rania Ali El-Farrash |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of types of phototherapy on change in CD4 and CD8 lymphocytes subsets | Detection of CD4 and CD8 absolute counts(x10³/uL) : was done before and 48 hours after phototherapy and for controls at time of examination using monoclonal antibodies and measured by flow cytometry | 2 days |
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