NCT07150494

Brief Summary

Early detection and prevention of neonatal encephalopathy using BIND score.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Oct 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Oct 2025Oct 2026

First Submitted

Initial submission to the registry

August 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

September 30, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 25, 2025

Last Update Submit

September 29, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Decrease high billirubin level

    We use bind score to evaluate neurological condition of neoborns then use photo therapy to decrease

    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.

    Baseline

  • Predictive and diagnostic value of BIND score in assessment of severe neonatal jaundice cases in NICU

    Baseline

Interventions

Phototherapy used to decrease high billirubin level in neonatal jaundice

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Neonates with severe neonatal jaundice

You may qualify if:

  • Newborn \< 28 days old Neonates with severe hyperbilirubinemia need extensive phototherapy impending exchange transfusion

You may not qualify if:

  • Age \> 28 days old Neonates with any abnormal neurological signs suggesting neurological disease (hypoxic ischemic encephalopathy, muscle disease, …etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 40815110BACKGROUND

Related Links

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Nouralhoda Ahmed Metwally

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nouralhoda Ahmed

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 2, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

September 30, 2025

Record last verified: 2025-08