Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:04 AM
Study NCT ID:
NCT07189494
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
European Newborn Study: Early Markers for a Better LifE
Sponsor:
dr. M.J.N.L. Benders
Organization:
Study Overview
Official Title:
ENSEMBLE: European Newborn Study: Early Markers for a Better LifE
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENSEMBLE
Brief Summary:
The goal of this observational study is to create a computer model to help doctors predict any problems occurring during development of babies after being diagnosed with brain injury. This will help provide better care to future babies. Next to this, the experiences of parents or caregivers surrounding the first two years after birth of a baby at risk of developing cerebral palsy will be researched to develop recommendations to support parents.
Parents of participants will:
\- Fill in two online questionnaires, one when their child is 3-4 months corrected age. The second when their child is 2 years corrected age.
For the child no additional tests are needed. Only tests that are part of standard clinical practice are performed and are also saved in the study database.
Parents of participants will:
\- Fill in two online questionnaires, one when their child is 3-4 months corrected age. The second when their child is 2 years corrected age.
For the child no additional tests are needed. Only tests that are part of standard clinical practice are performed and are also saved in the study database.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: