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Trial · NCT07882199

Registered outcomes57

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryBayley-III Motor Composite Scorecorrected age 6 months
This measure assesses the developmental functioning of infants and toddlers. The standard composite scores for each primary domain (Cognitive, Language, and Motor) range from a minimum of 40 to a maximum of 160. Higher scores indicate better developmental performance and a better outcome.
SecondaryGeneral Movement Optimality Score-Revisedbaseline
This observational assessment evaluates the quality of general movements, typically during the writhing movements period in preterm and term infants. The total score ranges from a minimum of 0 to a maximum of 38. Higher scores indicate better quality of movements, representing more optimal motor performance and a better outcome.
SecondaryGeneral Movement Optimality Score-Revisedcorrected age 6 weeks
This observational assessment evaluates the quality of general movements, typically during the writhing movements period in preterm and term infants. The total score ranges from a minimum of 0 to a maximum of 38. Higher scores indicate better quality of movements, representing more optimal motor performance and a better outcome.
SecondaryBayley-III Cognitive Composite Scorecorrected age 6 months
This measure assesses the developmental functioning of infants and toddlers. The standard composite scores for each primary domain (Cognitive, Language, and Motor) range from a minimum of 40 to a maximum of 160. Higher scores indicate better developmental performance and a better outcome.
SecondaryBayley-III Cognitive Composite Scorecorrected age 9 months
This measure assesses the developmental functioning of infants and toddlers. The standard composite scores for each primary domain (Cognitive, Language, and Motor) range from a minimum of 40 to a maximum of 160. Higher scores indicate better developmental performance and a better outcome.
SecondaryBayley-III Cognitive Composite Scorecorrected age 18 months
This measure assesses the developmental functioning of infants and toddlers. The standard composite scores for each primary domain (Cognitive, Language, and Motor) range from a minimum of 40 to a maximum of 160. Higher scores indicate better developmental performance and a better outcome.
SecondaryBayley-III Cognitive Composite Scorecorrected age 24 months
This measure assesses the developmental functioning of infants and toddlers. The standard composite scores for each primary domain (Cognitive, Language, and Motor) range from a minimum of 40 to a maximum of 160. Higher scores indicate better developmental performance and a better outcome.
SecondaryBayley-III Cognitive Composite Scorecorrected age 36 months
This measure assesses the developmental functioning of infants and toddlers. The standard composite scores for each primary domain (Cognitive, Language, and Motor) range from a minimum of 40 to a maximum of 160. Higher scores indicate better developmental performance and a better outcome.
SecondaryMotor Optimality Score-Revisedcorrected age 3 months
This observational tool assesses the concurrent motor repertoire and the quality of fidgety movements in infants, typically between 3 and 5 months of post-term age. The total score ranges from a minimum of 5 to a maximum of 28. Higher scores indicate more optimal motor performance and a better outcome.
SecondaryGross Motor Function Measurecorrected age 6 months
This observational tool evaluates changes in gross motor function. The total score is calculated as a percentage, ranging from a minimum of 0 to a maximum of 100. Higher scores indicate better gross motor function and a better outcome.
SecondaryGross Motor Function Measurecorrected age 9 months
This observational tool evaluates changes in gross motor function. The total score is calculated as a percentage, ranging from a minimum of 0 to a maximum of 100. Higher scores indicate better gross motor function and a better outcome.
SecondaryGross Motor Function Measurecorrected age 18 months
This observational tool evaluates changes in gross motor function. The total score is calculated as a percentage, ranging from a minimum of 0 to a maximum of 100. Higher scores indicate better gross motor function and a better outcome.
SecondaryGross Motor Function Measurecorrected age 24 months
This observational tool evaluates changes in gross motor function. The total score is calculated as a percentage, ranging from a minimum of 0 to a maximum of 100. Higher scores indicate better gross motor function and a better outcome.
SecondaryGross Motor Function Measurecorrected age 36 months
This observational tool evaluates changes in gross motor function. The total score is calculated as a percentage, ranging from a minimum of 0 to a maximum of 100. Higher scores indicate better gross motor function and a better outcome.
SecondaryHammersmith Infant Neurological Examinationcorrected age 3 months
This is a standardized clinical neurological examination for infants between 2 and 24 months of age. The global score ranges from a minimum of 0 to a maximum of 78. Higher scores indicate more optimal neurological development and a better outcome.
SecondaryHammersmith Infant Neurological Examinationcorrected age 6 months
This is a standardized clinical neurological examination for infants between 2 and 24 months of age. The global score ranges from a minimum of 0 to a maximum of 78. Higher scores indicate more optimal neurological development and a better outcome.
SecondaryHammersmith Infant Neurological Examinationcorrected age 9 months
This is a standardized clinical neurological examination for infants between 2 and 24 months of age. The global score ranges from a minimum of 0 to a maximum of 78. Higher scores indicate more optimal neurological development and a better outcome.
SecondaryHammersmith Infant Neurological Examinationcorrected age 18 months
This is a standardized clinical neurological examination for infants between 2 and 24 months of age. The global score ranges from a minimum of 0 to a maximum of 78. Higher scores indicate more optimal neurological development and a better outcome.
SecondaryInfant Sensory Profilebaseline
This caregiver questionnaire assesses sensory processing patterns in infants. It consists of 25 items, each rated on a 5-point scale. The total raw score ranges from a minimum of 25 to a maximum of 125. Higher scores indicate a greater frequency of the observed sensory behaviors, which typically reflects more atypical sensory processing (a worse outcome).
SecondaryInfant Sensory Profilecorrected age 6 weeks
This caregiver questionnaire assesses sensory processing patterns in infants. It consists of 25 items, each rated on a 5-point scale. The total raw score ranges from a minimum of 25 to a maximum of 125. Higher scores indicate a greater frequency of the observed sensory behaviors, which typically reflects more atypical sensory processing (a worse outcome).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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