Early diagnosis and intervention for cerebral palsy in infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of an early diagnosis and intervention program for infants at risk of cerebral palsy. The study will include 500 infants from both newborn and infant detectable risk pathways across four pediatric centers in Denmark. It will systematically collect data on the infants' responses to the early intervention program, which is designed to be added to standard care. The goal is to demonstrate that this combined approach leads to better outcomes compared to standard care alone.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Group A: 'Newborn-detectable risk-pathway'

* Preterm birth with gestational age below 32 or birth weight below 1500 g and clinical concern
* Moderate to severe brain injury (Papile grade 3 to 4 intraventricular haemorrhage, cystic periventricular leukomalacia, neonatal stroke, term hypoxic-ischaemic encephalopathy (≥35 weeks gestation at birth) or other significant neurological condition)
* History (e.g. neonatal seizures, Extra Corporal Membrane Oxygenation, meningitis, kernicterus, severe hypoglycemia) or neurological risk factors (brain malformation, increased tone)
* Parental concern and one of the factors above

Group B: 'Infant detectable risk-pathway'

* Inability to sit independently by age 9 months
* Hand function asymmetry or crawl asymmetry
* Inability to take weight through the plantar surface of the feet
* History (as above) or neurological risk factors
* Parental concern and one of the factors above

Exclusion Criteria:

* 1\) Infants with progressive or neurodegenerative disorders or genetic disorders not associated with CP, 2) Infants with other disability diagnoses e.g. Down Syndrome.

Where it's running

• University Hospital Aalborg
  Aalborg, Denmark Recruiting
• University Hospital Aarhus
  Aarhus, Denmark Recruiting
• University Hospital Herlev
  Herlev, Denmark Recruiting
• University Hospital Rigshospitalet, Dept. Paediatrics
  Copenhagen, Østerbro, Denmark Recruiting

Study contacts

• Study coordinator: Christina E Hoei-Hansen
• Email: christina.hoei-hansen@regionh.dk
• Phone: +4535455095

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.