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

NCT ID: NCT04373980

Last Updated: 2020-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-01-01

Brief Summary

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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

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Conditions

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Neonatal Hyperbilirubinemia Phototherapy Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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conventional phototherapy

neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy

Group Type ACTIVE_COMPARATOR

phototherapy

Intervention Type DEVICE

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

LED phototherapy

neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy

Group Type ACTIVE_COMPARATOR

phototherapy

Intervention Type DEVICE

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

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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phototherapy

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rania Ali El-Farrash

OTHER

Sponsor Role lead

Responsible Party

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Rania Ali El-Farrash

Assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU 000017585

Identifier Type: -

Identifier Source: org_study_id

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