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

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 Overview

• Status: Completed
• Conditions: Neonatal Hyperbilirubinemia; Phototherapy Complication
• Intervention / Treatment: Device: phototherapy

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 1138
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control group
ACTIVE_COMPARATOR: conventional phototherapy; neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy	Device: phototherapy; estimate CD4 and CD8 subsets in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy
ACTIVE_COMPARATOR: LED phototherapy; neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy	Device: phototherapy; estimate CD4 and CD8 subsets in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rania Ali El-Farrash

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): July 30, 2019
• Study Completion (ACTUAL): January 1, 2020

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (ACTUAL): May 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal
• Other Study ID Numbers: FMASU 000017585

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No