Neonatal HyperbilirubinemiaNCT07150494
Predictive and Diagnostic Value of BIND Score in Assessment of Severe Neonatal Jaundice Cases in Neonatal Intensive Care Unit
An observational study of Neonatal Hyperbilirubinemia, run by Assiut University.
Trial summary
Early detection and prevention of neonatal encephalopathy using BIND score. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Neonatal Hyperbilirubinemia
- What is being tested?
- Phototherapy
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Child
Study population: Neonates with severe neonatal jaundice
Who may be able to join
- Newborn < 28 days old Neonates with severe hyperbilirubinemia need extensive phototherapy impending exchange transfusion
Who cannot join
- Age > 28 days old Neonates with any abnormal neurological signs suggesting neurological disease (hypoxic ischemic encephalopathy, muscle disease, …etc.).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Predictive and Diagnostic Value of BIND Score in Assessment of Severe Neonatal Jaundice Cases in NICU
Early detection and prevention of neonatal encephalopathy using BIND score.
- Conditions
- Neonatal Hyperbilirubinemia
- 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
Phototherapy used to decrease high billirubin level in neonatal jaundice
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease high billirubin level
We use bind score to evaluate neurological condition of neoborns then use photo therapy to decrease
Measured: One year duration
Predictive and diagnostic value of BIND score in assessment of severe neonatal jaundice cases in NICU
Early detection and prevention of neonatal encephalopathy using BIND score.
Measured: Baseline
Predictive and diagnostic value of BIND score in assessment of severe neonatal jaundice cases in NICU
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal HyperbilirubinemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouralhoda Ahmed Metwally Ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150494
- Sponsor's protocol ID
- Neonatal jaundice cases in nic
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vongbhavit K, Rearkyai S, Janyoungsak P, Panburana J. Impact of 2022 AAP Neonatal Hyperbilirubinemia Guidelines in a Middle-Income Country: A Single-Center Study in Thailand. Neonatology. 2025;122(6):660-668. doi: 10.1159/000547630. Epub 2025 Aug 13.
PubMed 40815110
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive and Diagnostic Value of BIND Score in Assessment of Severe Neonatal Jaundice Cases in NICU
- ClinicalTrials.gov ID
- NCT07150494
- Acronym / sponsor ID
- Neonatal jaundice cases in nic
- Conditions
- Neonatal Hyperbilirubinemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 2 Sep 2025 (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.
Early detection and prevention of neonatal encephalopathy using BIND score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- Neonates with severe neonatal jaundice
Key inclusion criteria (1 listed)
- Newborn < 28 days old Neonates with severe hyperbilirubinemia need extensive phototherapy impending exchange transfusion
Key exclusion criteria (1 listed)
- Age > 28 days old Neonates with any abnormal neurological signs suggesting neurological disease (hypoxic ischemic encephalopathy, muscle disease, …etc.).
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 |
|---|---|---|
| PhototherapyPhototherapy used to decrease high billirubin level in neonatal jaundice | Device | – |
Primary outcome
Decrease high billirubin level
Time frame: One year duration
We use bind score to evaluate neurological condition of neoborns then use photo therapy to decrease
Predictive and diagnostic value of BIND score in assessment of severe neonatal jaundice cases in NICU
Time frame: Baseline
Early detection and prevention of neonatal encephalopathy using BIND score.
Predictive and diagnostic value of BIND score in assessment of severe neonatal jaundice cases in NICU
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Background: PubMed 40815110Vongbhavit K, Rearkyai S, Janyoungsak P, Panburana J. Impact of 2022 AAP Neonatal Hyperbilirubinemia Guidelines in a Middle-Income Country: A Single-Center Study in Thailand. Neonatology. 2025;122(6):660-668. doi: 10.1159/000547630. Epub 2025 Aug 13.
- Related InfoLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Hyperbilirubinemia, run by Assiut University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nouralhoda Ahmed Metwally (+201012527376, nouralhoda2712@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease high billirubin level (time frame: One year duration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07150494, which also lists 1 linked publication.
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 30 Sep 2025.