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Clinical Trials/NCT04373980
NCT04373980
Completed
Not Applicable

Conventional Versus LED Phototherapy and Their Effect on Lymphocytes Subsets of Full Term Neonates With Hyperbilirubinemia

Rania Ali El-Farrash1 site in 1 country60 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neonatal Hyperbilirubinemia
Sponsor
Rania Ali El-Farrash
Enrollment
60
Locations
1
Primary Endpoint
Effect of types of phototherapy on change in CD4 and CD8 lymphocytes subsets
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
January 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Rania Ali El-Farrash
Responsible Party
Sponsor Investigator
Principal Investigator

Rania Ali El-Farrash

Assistant professor

Ain Shams University

Eligibility Criteria

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.
  • 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

Outcomes

Primary Outcomes

Effect of types of phototherapy on change in CD4 and CD8 lymphocytes subsets

Time Frame: 2 days

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

Study Sites (1)

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