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

Investigating Early Therapy for Extremely Preterm Infants with Brain Damage

Recruiting
10 years - 199 years
Female
Phase 3
190 participants needed
1 Location

Study Overview

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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Study Details

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 Criteria

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

  • Conditions: Deficits, Neurologic, Extreme Prematurity, Brain Damage
  • Age: 10 years - 199 years
  • Gender: Female

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 30 May 2025. Study ID: TX217223

This study investigates the developmental outcomes and effectiveness of early neurorehabilitation interventions in infants and toddlers born extremely preterm, specifically those with neurologic deficits due to prematurity-associated brain damage. Extremely preterm refers to infants born before 28 weeks of gestation. Neurologic deficits may include conditions such as intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL), which are types of brain damage that can occur in these infants.

Participants will undergo various procedures, including neurodevelopmental assessments, imaging, and caregiver-reported outcomes. There is an optional intervention arm where infants may receive physical, occupational, and cognitive therapy starting within 6 months of corrected age. The study will also observe infants over a period of time to assess cognitive and motor function, degree of cerebral palsy, and other sensory impairments. An observational study is a type of research study where data is collected by observing participants receiving routine care, without changing their treatment, which may focus on people using specific medications or having certain conditions to better understand how treatments work.

  • Who can participate: Infants born at less than 28 weeks of gestation and up to 6 months corrected age with documented neurologic damage and clinical deficits are eligible. Parents or legal guardians must provide informed consent and plan for long-term follow-up care.
  • Study details: Participants may receive standard assessments and optional therapies, including physical, occupational, and cognitive therapy. The study involves observational data collection and optional interventions.

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