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

Not Applicable

Completed

• Conditions: Neonatal Hyperbilirubinemia; Phototherapy Complication
• Interventions: Device: phototherapy

• Registration Number: NCT04373980
• Lead Sponsor: Rania Ali El-Farrash

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-07-30
• Study Completion: 2020-01-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-05-04
• Last Update Submitted: 2020-05-04
• Study First Posted: 2020-05-05
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
conventional phototherapy	phototherapy	neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy
LED phototherapy	phototherapy	neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt