Test Trial - v7.2 (Do not make changes) (Staging)

Department
Test Trial - v7.2 (Do not make changes)
Recruiting
20 years - 90 years
All
Phase 2
90 participants needed
1 Location

Brief description of study

To evaluate the developmental outcomes and efficacy of early neurorehabilitation interventions in infants and toddlers born extremely preterm (<28 weeks gestation) with neurologic deficits related to prematurity-associated brain damage, such as intraventricular haemorrhage (IVH) or periventricular leukomalacia (PVL).

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Detailed description of study

Study Design:

  • Observational cohort with longitudinal follow-up over 3 years

  • Data collection through neurodevelopmental assessments, imaging, and caregiver-reported outcomes

  • Optional intervention arm with physical, occupational, and cognitive therapy starting within 6 months corrected age

Study Population:
Infants born at <28 weeks gestation diagnosed with moderate to severe neurologic impairment due to documented brain injury on imaging within the neonatal intensive care unit (NICU) stay.

Primary Endpoints:

  • Cognitive and motor function at 6, 12, 24, and 36 months corrected age (measured using Bayley Scales of Infant and Toddler Development or similar tools)

  • Degree of cerebral palsy, gross motor function, and sensory impairments

Secondary Endpoints:

  • Parental stress and quality of life

  • Rates of hospital readmission and seizure occurrence

  • Correlation between type/severity of brain damage and long-term outcomes

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Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Deficits, Neurologic, Extreme Prematurity, Brain Damage
  • Age: 20 years - 90 years
  • Gender: All

Inclusion Criteria:

  • Infants born at <28 weeks gestation (extremely preterm)

  • Age at enrollment ≤6 months corrected age

  • Documented neurologic damage on cranial ultrasound or MRI (e.g., Grade III–IV IVH, PVL, hypoxic-ischemic encephalopathy)

  • Presence of clinical neurologic deficits such as hypotonia, hypertonia, delayed motor milestones, or seizures

  • Parent/legal guardian willing and able to provide informed consent

  • Plan for long-term follow-up care within the participating institutions

Exclusion Criteria:

  • Genetic syndromes or chromosomal abnormalities (e.g., Trisomy 21) associated with developmental delay

  • Major congenital anomalies (e.g., congenital heart disease requiring surgery)

  • Infants with non-neurologic causes of developmental delay (e.g., metabolic disorders)

  • Families unable or unwilling to participate in follow-up assessments

  • Previous enrollment in a similar neurodevelopmental intervention trial

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Online study
Updated on 18 May 2025. Study ID: NEUR-WU-BROSCH-DIANTU0022

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