Neonatal HyperbilirubinemiaNCT04373980
Conventional Versus LED Phototherapy and Their Effect on Lymphocytes Subsets of Full Term Neonates With Hyperbilirubinemia
A study testing phototherapy in people with Neonatal Hyperbilirubinemia and Phototherapy Complication, run by Rania Ali El-Farrash at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Hyperbilirubinemia, Phototherapy Complication
- What is being tested?
- phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- phototherapy
- Medical subject headings
- Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phototherapyDevice
estimate CD4 and CD8 subsets in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy
| Study group | Role | What they receive |
|---|---|---|
| conventional phototherapy | Active comparator | neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy Receives: Device: phototherapy |
| LED phototherapy | Active comparator | neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy Receives: Device: phototherapy |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Jan 2019
- Primary completion30 Jul 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HyperbilirubinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rania Ali El-Farrash
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rania Ali El-Farrash, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373980
- Sponsor's protocol ID
- FMASU 000017585
- Status last verified
- Apr 2020
- First submitted
- 28 Apr 2020
- Last updated
- 5 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Versus LED Phototherapy and Their Effect on Lymphocytes Subsets of Full Term Neonates With Hyperbilirubinemia
- ClinicalTrials.gov ID
- NCT04373980
- Acronym / sponsor ID
- FMASU 000017585
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rania Ali El-FarrashUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional phototherapy | Active comparator | Device: phototherapyneonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy |
| LED phototherapy | Active comparator | Device: phototherapyneonates with unconjugated hyperbilirubinemia exposed to LED phototherapy |
| Control group | No intervention | – |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Total bilirubin level of >20 mg/dl.
- Prematurity.
- Sepsis.
- Congenital anomaly.
- Elevation in direct bilirubin level.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phototherapyestimate CD4 and CD8 subsets in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy | Device | LED phototherapy, conventional phototherapy |
Primary outcome
Effect of types of phototherapy on change in CD4 and CD8 lymphocytes subsets
Time frame: 2 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phototherapy in people with Neonatal Hyperbilirubinemia and Phototherapy Complication, run by Rania Ali El-Farrash at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of types of phototherapy on change in CD4 and CD8 lymphocytes subsets (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.