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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04373980
Enrollment
60
Registered
2020-05-05
Start date
2019-01-01
Completion date
2020-01-01
Last updated
2020-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Hyperbilirubinemia, Phototherapy Complication

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.

Interventions

DEVICEphototherapy

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

Sponsors

Rania Ali El-Farrash
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Effect of types of phototherapy on change in CD4 and CD8 lymphocytes subsets2 daysDetection 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026