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

Rania Ali El-Farrash

Status: Completed

Conditions: Phototherapy Complication; Neonatal Hyperbilirubinemia

Treatments: Device: phototherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04373980

FMASU 000017585

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

conventional phototherapy

Active Comparator group

Description:

neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy

Treatment:

Device: phototherapy

LED phototherapy

Active Comparator group

Description:

neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy

Treatment:

Device: phototherapy

Control group

No Intervention group