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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 30, 2019

Interventions

  • Device: phototherapy
    • estimate CD4 and CD8 subsets in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy

Arms, Groups and Cohorts

  • Active Comparator: conventional phototherapy
    • neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy
  • Active Comparator: LED phototherapy
    • neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy
  • No Intervention: Control group

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 28 Days

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rania Ali El-Farrash
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Rania Ali El-Farrash, Assistant professor – Ain Shams University

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