Conventional Versus LED Phototherapy and Their Effect on Lymphocytes Subsets of Full Term Neonates With Hyperbilirubinemia
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 28, 2020
CompletedFirst Posted
Study publicly available on registry
May 5, 2020
CompletedMay 5, 2020
April 1, 2020
7 months
April 28, 2020
May 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
conventional phototherapy
ACTIVE COMPARATORneonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy
LED phototherapy
ACTIVE COMPARATORneonates with unconjugated hyperbilirubinemia exposed to LED phototherapy
Control group
NO INTERVENTIONInterventions
estimate CD4 and CD8 subsets in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University
Cairo, 1138, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
April 28, 2020
First Posted
May 5, 2020
Study Start
January 1, 2019
Primary Completion
July 30, 2019
Study Completion
January 1, 2020
Last Updated
May 5, 2020
Record last verified: 2020-04