Back to resultsConventional Versus LED Phototherapy and Their Effect on Lymphocytes Subsets of Full Term Neonates With Hyperbilirubinemia
Primary Purpose
Neonatal Hyperbilirubinemia, Phototherapy Complication
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
phototherapy
Sponsored by
About this trial
This is an interventional treatment trial for Neonatal Hyperbilirubinemia
Eligibility Criteria
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
Sites / Locations
- Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
conventional phototherapy
LED phototherapy
Control group
Arm Description
neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy
neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04373980
Brief Title
Conventional Versus LED Phototherapy and Their Effect on Lymphocytes Subsets of Full Term Neonates With Hyperbilirubinemia
Official Title
Conventional Versus LED Phototherapy and Their Effect on Lymphocytes Subsets of Full Term Neonates With Hyperbilirubinemia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rania Ali El-Farrash
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hyperbilirubinemia, Phototherapy Complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional phototherapy
Arm Type
Active Comparator
Arm Description
neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy
Arm Title
LED phototherapy
Arm Type
Active Comparator
Arm Description
neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
phototherapy
Intervention Description
estimate CD4 and CD8 subsets in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy
Primary Outcome Measure Information:
Title
Effect of types of phototherapy on change in CD4 and CD8 lymphocytes subsets
Description
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
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
1138
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Conventional Versus LED Phototherapy and Their Effect on Lymphocytes Subsets of Full Term Neonates With Hyperbilirubinemia
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