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

Neonatal Hyperbilirubinemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04373980
• Other study ID #: FMASU 000017585
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: April 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Neonatal Hyperbilirubinemia
• Phototherapy Complication

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Rania Ali El-Farrash

Country where clinical trial is conducted

Egypt, 

Outcome

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