NCT07198360

Brief Summary

To determine the incidence and grading of IVH among preterm neonates in the NICU.

  • To identify maternal and neonatal risk factors associated with IVH.
  • To assess short-term outcomes (mortality, Hydrocephalus, need for neurosurgical intervention, seizures, length of Hospital stay).

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Sep 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 Progress68%
Sep 2025Sep 2026

Study Start

First participant enrolled

September 1, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

September 14, 2025

Last Update Submit

September 21, 2025

Conditions

Intraventricular Hemorrhage of Prematurity

Outcome Measures

Primary Outcomes (1)

  • . To determine the incidence of IVH in preterm infants within the first 7 days of life using cranial ultrasound. . To assess the grade of IVH (Papile classification I-IV) in preterm infants based on cranial US findings.

    Outcome of intraventricular haemorrhage in preterm infants

    Baseline

Interventions

No interventionOTHER

Not found

Eligibility Criteria

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

All with the required Criteria

You may qualify if:

  • Preterm neonates \< 34 weeks of gestation
  • Birth weight \< 1500g
  • Admitted to NICU within 24 hours of birth

You may not qualify if:

  • Major congenital malformations (especially CNS anomalies)
  • Severe perinatal asphyxia
  • Neonates with congenital infections (TORCH)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Parodi A, Govaert P, Horsch S, Bravo MC, Ramenghi LA; eurUS.brain group. Cranial ultrasound findings in preterm germinal matrix haemorrhage, sequelae and outcome. Pediatr Res. 2020 Mar;87(Suppl 1):13-24. doi: 10.1038/s41390-020-0780-2.

    PMID: 32218535BACKGROUND

  • Kolnik SE, Upadhyay K, Wood TR, Juul SE, Valentine GC. Reducing Severe Intraventricular Hemorrhage in Preterm Infants With Improved Care Bundle Adherence. Pediatrics. 2023 Sep 1;152(3):e2021056104. doi: 10.1542/peds.2021-056104.

    PMID: 37609772BACKGROUND

  • Legge N, Lutz T, Wocadlo C, Rieger I. Long-term neurodevelopmental outcome in preterm infants with intraventricular haemorrhage. J Paediatr Child Health. 2022 Oct;58(10):1797-1802. doi: 10.1111/jpc.16108. Epub 2022 Jul 15.

    PMID: 35837759BACKGROUND

Central Study Contacts

Romany Nady Isaac Ayad

CONTACT

01142602768romanynady2223@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric resident

Study Record Dates

First Submitted

September 14, 2025

First Posted

September 30, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share