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

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    Recruiting
  • participants needed
    33
  • sponsor
    TrialX
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Updated on 29 May 2025
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Summary

Published Study 1To 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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This text will be aligned to the Justify - 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.

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Description

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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Details
Condition Diabetes
Age 10years - 70years
Clinical Study IdentifierTX13991
SponsorTrialX
Last Modified on29 May 2025

Eligibility

 Yes No Not Sure

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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diagnosed with moderate to severe neurologic impairment due to documented
brain injury on imaging within the neonatal intensive care unit (NICU) stay
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