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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04373980
Other study ID # FMASU 000017585
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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