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CompletedNCT04373980Updated May 5, 2020

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

An interventional study of phototherapy in Neonatal Hyperbilirubinemia and Phototherapy Complication, sponsored by Rania Ali El-Farrash. Completed at 1 site in Egypt. Open to participants aged 1 Day to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-05.

Sponsored by Rania Ali El-Farrash · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jan 2019, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
1 Day to 28 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Neonatal Hyperbilirubinemia
  • Phototherapy Complication
03

In context

Hyperbilirubinemia, Neonatal

96 studies on the registry are indexed under Hyperbilirubinemia, Neonatal; 20 are open to participants now.

This study's enrollment of 60 is below the median of 100 across 61 interventional studies indexed under Hyperbilirubinemia, Neonatal.

Browse Hyperbilirubinemia, Neonatal studies →

Lead sponsor

Rania Ali El-Farrash is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 28 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.

  • indirect hyperbilirubinemia requiring phototherapy in the first week of life.
  • No pathologic etiological factors for hyperbilirubinemia

Exclusion criteria

Exclusion Criteria:

  • Total 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    conventional phototherapy

    neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy

    Device: phototherapy

  • Active comparator
    LED phototherapy

    neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy

    Device: phototherapy

  • No intervention
    Control group

Interventions

  • Devicephototherapy

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

06

What researchers measure

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

    Time frame: 2 days

07

Study locations

1 site
  • Ain Shams University
    Cairo, 1138, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2019 to primary completion in Jul 2019, 6 months.

Of 34 non-industry interventional studies with no phase under Hyperbilirubinemia, Neonatal, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's 6 months is below that.

Counting every sponsor, half of 34 studies reached it within 10 months; a quarter within 6 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 28, 2020
First posted
May 5, 2020
StartActual
Jan 1, 2019
Primary completionActual
Jul 30, 2019
CompletionActual
Jan 1, 2020
Last update
May 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04373980
Lead sponsor
Rania Ali El-Farrash
Responsible party
Rania Ali El-Farrash (Assistant professor, Ain Shams University) — Sponsor-investigator
First posted
May 5, 2020
Start date
Jan 1, 2019
Primary completion
Jul 30, 2019
Completion
Jan 1, 2020
Last update
May 5, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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