PretermNCT07882199
Efficacy of a Video-based, Parent-centered Home Developmental Intervention for Infants at High Risk for Developmental Delay: a Multicenter Randomized Controlled Trial
A study testing Family-centered developmental training intervention in people with Preterm, run by Seoul National University Hospital.
Trial summary
The purpose of this study is to determine whether the Motor Composite Score on the Bayley-III (administered at 6 months of corrected age) shows significant improvement in an intervention group-receiving usual care combined with a video-based home developmental intervention-compared to a control group receiving only… Read more about this study
- Who is it for?
- Ages 0 weeks to 1 month
- Conditions the study is for
- Preterm
- What is being tested?
- Family-centered developmental training intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 weeks to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants born at less than 32 weeks of gestation
- Presence of brain injury confirmed via brain imaging (e.g., cranial ultrasound, brain MRI)
Who cannot join
- Premature infants with a corrected age exceeding one month
- Presence of seizures uncontrolled by medication
- Presence of multiple or genetic malformations
- Presence of severe visual or auditory impairment
- Impaired level of consciousness
- History of tracheostomy
- Unstable vital signs
About this study
The purpose of this study is to determine whether the Motor Composite Score on the Bayley-III (administered at 6 months of corrected age) shows significant improvement in an intervention group-receiving usual care combined with a video-based home developmental intervention-compared to a control group receiving only usual care, among infants at high risk for developmental delay. The study subjects are infants discharged from the Neonatal Intensive Care Unit (NICU) who were born prematurely at a gestational age of less than 32 weeks or who sustained brain injury. The control group receives usual care only, while the intervention group receives usual care plus a parent-centered developmental training intervention. Parent education for this intervention involves 1:1 monitoring via video conferencing platforms to facilitate parent-centered early intervention at home; sessions last 30 minutes and are conducted once weekly from 0 to 3 months of corrected age and twice weekly from 4 to 6 months of corrected age.
- Conditions
- Preterm
- Being tested
- Family-centered developmental training intervention
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-centered developmental training interventionOther
In parent-centered developmental training interventions, parents administer developmental training to their infants at home, focusing on specific tasks selected by a therapist from a range of activities-such as motor play, look and see play, tactile play, and verbal play. Up to four tasks may be selected per day, with specific parameters regarding sessions, sets, and repetitions determined by medical staff or therapists based on the infant's performance. The program is implemented seven days a week.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Not described |
| Usual care + Family-centered developmental training intervention | Experimental | Not described Receives: Other: Family-centered developmental training intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley-III Motor Composite Score
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.
Measured: corrected age 6 months
Secondary outcomes (56)
General Movement Optimality Score-Revised
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.
Measured: baseline
General Movement Optimality Score-Revised
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.
Measured: corrected age 6 weeks
Bayley-III Cognitive Composite Score
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.
Measured: corrected age 6 months
Bayley-III Cognitive Composite Score
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.
Measured: corrected age 9 months
Bayley-III Cognitive Composite Score
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.
Measured: corrected age 18 months
Bayley-III Cognitive Composite Score
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.
Measured: corrected age 24 months
Bayley-III Cognitive Composite Score
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.
Measured: corrected age 36 months
Motor Optimality Score-Revised
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.
Measured: corrected age 3 months
Gross Motor Function Measure
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.
Measured: corrected age 6 months
Gross Motor Function Measure
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.
Measured: corrected age 9 months
Gross Motor Function Measure
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.
Measured: corrected age 18 months
Gross Motor Function Measure
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.
Measured: corrected age 24 months
Gross Motor Function Measure
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.
Measured: corrected age 36 months
Hammersmith Infant Neurological Examination
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.
Measured: corrected age 3 months
Hammersmith Infant Neurological Examination
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.
Measured: corrected age 6 months
Hammersmith Infant Neurological Examination
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.
Measured: corrected age 9 months
Hammersmith Infant Neurological Examination
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.
Measured: corrected age 18 months
Infant Sensory Profile
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).
Measured: baseline
Infant Sensory Profile
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).
Measured: corrected age 6 weeks
Infant Sensory Profile
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).
Measured: corrected age 3 months
Infant Sensory Profile
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).
Measured: corrected age 6 months
Toddler Sensory Profile
This caregiver questionnaire assesses sensory processing patterns in toddlers. It consists of 54 items, each rated on a 5-point scale. The total raw score ranges from a minimum of 54 to a maximum of 270. Higher scores indicate a greater frequency of the observed sensory behaviors, which typically reflects more atypical sensory processing (a worse outcome).
Measured: corrected age 9 months
Toddler Sensory Profile
This caregiver questionnaire assesses sensory processing patterns in toddlers. It consists of 54 items, each rated on a 5-point scale. The total raw score ranges from a minimum of 54 to a maximum of 270. Higher scores indicate a greater frequency of the observed sensory behaviors, which typically reflects more atypical sensory processing (a worse outcome).
Measured: corrected age 18 months
Toddler Sensory Profile
This caregiver questionnaire assesses sensory processing patterns in toddlers. It consists of 54 items, each rated on a 5-point scale. The total raw score ranges from a minimum of 54 to a maximum of 270. Higher scores indicate a greater frequency of the observed sensory behaviors, which typically reflects more atypical sensory processing (a worse outcome).
Measured: corrected age 24 months
Child Sensory Profile
This caregiver questionnaire assesses sensory processing patterns in children. It consists of 86 items, each rated on a 5-point scale. The total raw score ranges from a minimum of 86 to a maximum of 430. Higher scores indicate a greater frequency of the observed sensory behaviors, which typically reflects more atypical sensory processing (a worse outcome).
Measured: corrected age 36 months
Parent Health Questionnaire-9
This instrument measures health-related quality of life in infants. The item responses are linearly transformed to a 0 to 100 scale. The total score ranges from a minimum of 0 to a maximum of 100. Higher scores indicate better health-related quality of life and a better outcome.
Measured: baseline
Parent Health Questionnaire-9
This instrument measures health-related quality of life in infants. The item responses are linearly transformed to a 0 to 100 scale. The total score ranges from a minimum of 0 to a maximum of 100. Higher scores indicate better health-related quality of life and a better outcome.
Measured: corrected age 6 weeks
Parent Health Questionnaire-9
This instrument measures health-related quality of life in infants. The item responses are linearly transformed to a 0 to 100 scale. The total score ranges from a minimum of 0 to a maximum of 100. Higher scores indicate better health-related quality of life and a better outcome.
Measured: corrected age 3 months
Parent Health Questionnaire-9
This instrument measures health-related quality of life in infants. The item responses are linearly transformed to a 0 to 100 scale. The total score ranges from a minimum of 0 to a maximum of 100. Higher scores indicate better health-related quality of life and a better outcome.
Measured: corrected age 6 months
Parent Health Questionnaire-9
This instrument measures health-related quality of life in infants. The item responses are linearly transformed to a 0 to 100 scale. The total score ranges from a minimum of 0 to a maximum of 100. Higher scores indicate better health-related quality of life and a better outcome.
Measured: corrected age 18 months
Parent Health Questionnaire-9
This instrument measures health-related quality of life in infants. The item responses are linearly transformed to a 0 to 100 scale. The total score ranges from a minimum of 0 to a maximum of 100. Higher scores indicate better health-related quality of life and a better outcome.
Measured: corrected age 24 months
Parent Health Questionnaire-9
This instrument measures health-related quality of life in infants. The item responses are linearly transformed to a 0 to 100 scale. The total score ranges from a minimum of 0 to a maximum of 100. Higher scores indicate better health-related quality of life and a better outcome.
Measured: corrected age 36 months
Parenting Sense of Competence
This scale evaluates parents' self-efficacy and satisfaction with their parenting role. It consists of 17 items rated on a 6-point scale. The total score ranges from a minimum of 17 to a maximum of 102. Higher scores indicate a greater sense of parenting competence and satisfaction, representing a better outcome.
Measured: baseline
Parenting Sense of Competence
This scale evaluates parents' self-efficacy and satisfaction with their parenting role. It consists of 17 items rated on a 6-point scale. The total score ranges from a minimum of 17 to a maximum of 102. Higher scores indicate a greater sense of parenting competence and satisfaction, representing a better outcome.
Measured: corrected age 6 weeks
Parenting Sense of Competence
This scale evaluates parents' self-efficacy and satisfaction with their parenting role. It consists of 17 items rated on a 6-point scale. The total score ranges from a minimum of 17 to a maximum of 102. Higher scores indicate a greater sense of parenting competence and satisfaction, representing a better outcome.
Measured: corrected age 3 months
Parenting Sense of Competence
This scale evaluates parents' self-efficacy and satisfaction with their parenting role. It consists of 17 items rated on a 6-point scale. The total score ranges from a minimum of 17 to a maximum of 102. Higher scores indicate a greater sense of parenting competence and satisfaction, representing a better outcome.
Measured: corrected age 6 months
Parenting Sense of Competence
This scale evaluates parents' self-efficacy and satisfaction with their parenting role. It consists of 17 items rated on a 6-point scale. The total score ranges from a minimum of 17 to a maximum of 102. Higher scores indicate a greater sense of parenting competence and satisfaction, representing a better outcome.
Measured: corrected age 9 months
Parenting Sense of Competence
This scale evaluates parents' self-efficacy and satisfaction with their parenting role. It consists of 17 items rated on a 6-point scale. The total score ranges from a minimum of 17 to a maximum of 102. Higher scores indicate a greater sense of parenting competence and satisfaction, representing a better outcome.
Measured: corrected age 18 months
Parenting Sense of Competence
This scale evaluates parents' self-efficacy and satisfaction with their parenting role. It consists of 17 items rated on a 6-point scale. The total score ranges from a minimum of 17 to a maximum of 102. Higher scores indicate a greater sense of parenting competence and satisfaction, representing a better outcome.
Measured: corrected age 24 months
Parenting Sense of Competence
This scale evaluates parents' self-efficacy and satisfaction with their parenting role. It consists of 17 items rated on a 6-point scale. The total score ranges from a minimum of 17 to a maximum of 102. Higher scores indicate a greater sense of parenting competence and satisfaction, representing a better outcome.
Measured: corrected age 36 months
Parent Stress Index
This instrument measures the magnitude of stress in the parent-child system. For the widely used Short Form, the total score ranges from a minimum of 36 to a maximum of 180. Higher scores indicate greater levels of parenting stress, representing a worse outcome.
Measured: baseline
Parent Stress Index
This instrument measures the magnitude of stress in the parent-child system. For the widely used Short Form, the total score ranges from a minimum of 36 to a maximum of 180. Higher scores indicate greater levels of parenting stress, representing a worse outcome.
Measured: corrected age 6 weeks
Parent Stress Index
This instrument measures the magnitude of stress in the parent-child system. For the widely used Short Form, the total score ranges from a minimum of 36 to a maximum of 180. Higher scores indicate greater levels of parenting stress, representing a worse outcome.
Measured: corrected age 3 months
Parent Stress Index
This instrument measures the magnitude of stress in the parent-child system. For the widely used Short Form, the total score ranges from a minimum of 36 to a maximum of 180. Higher scores indicate greater levels of parenting stress, representing a worse outcome.
Measured: corrected age 6 months
Parent Stress Index
This instrument measures the magnitude of stress in the parent-child system. For the widely used Short Form, the total score ranges from a minimum of 36 to a maximum of 180. Higher scores indicate greater levels of parenting stress, representing a worse outcome.
Measured: corrected age 9 months
Parent Stress Index
This instrument measures the magnitude of stress in the parent-child system. For the widely used Short Form, the total score ranges from a minimum of 36 to a maximum of 180. Higher scores indicate greater levels of parenting stress, representing a worse outcome.
Measured: corrected age 18 months
Parent Stress Index
This instrument measures the magnitude of stress in the parent-child system. For the widely used Short Form, the total score ranges from a minimum of 36 to a maximum of 180. Higher scores indicate greater levels of parenting stress, representing a worse outcome.
Measured: corrected age 24 months
Parent Stress Index
This instrument measures the magnitude of stress in the parent-child system. For the widely used Short Form, the total score ranges from a minimum of 36 to a maximum of 180. Higher scores indicate greater levels of parenting stress, representing a worse outcome.
Measured: corrected age 36 months
Pediatric Quality of Life Inventory
This instrument measures health-related quality of life in infants. The item responses are linearly transformed to a 0 to 100 scale. The total score ranges from a minimum of 0 to a maximum of 100. Higher scores indicate better health-related quality of life and a better outcome.
Measured: baseline
Pediatric Quality of Life Inventory
This instrument measures health-related quality of life in infants. The item responses are linearly transformed to a 0 to 100 scale. The total score ranges from a minimum of 0 to a maximum of 100. Higher scores indicate better health-related quality of life and a better outcome.
Measured: corrected age 6 weeks
Pediatric Quality of Life Inventory
This instrument measures health-related quality of life in infants. The item responses are linearly transformed to a 0 to 100 scale. The total score ranges from a minimum of 0 to a maximum of 100. Higher scores indicate better health-related quality of life and a better outcome.
Measured: corrected age 3 months
Pediatric Quality of Life Inventory
This instrument measures health-related quality of life in infants. The item responses are linearly transformed to a 0 to 100 scale. The total score ranges from a minimum of 0 to a maximum of 100. Higher scores indicate better health-related quality of life and a better outcome.
Measured: corrected age 6 months
Pediatric Quality of Life Inventory
This instrument measures health-related quality of life in infants. The item responses are linearly transformed to a 0 to 100 scale. The total score ranges from a minimum of 0 to a maximum of 100. Higher scores indicate better health-related quality of life and a better outcome.
Measured: corrected age 9 months
Pediatric Quality of Life Inventory
This instrument measures health-related quality of life in infants. The item responses are linearly transformed to a 0 to 100 scale. The total score ranges from a minimum of 0 to a maximum of 100. Higher scores indicate better health-related quality of life and a better outcome.
Measured: corrected age 18 months
Pediatric Quality of Life Inventory
This instrument measures health-related quality of life in infants. The item responses are linearly transformed to a 0 to 100 scale. The total score ranges from a minimum of 0 to a maximum of 100. Higher scores indicate better health-related quality of life and a better outcome.
Measured: corrected age 24 months
Pediatric Quality of Life Inventory
This instrument measures health-related quality of life in infants. The item responses are linearly transformed to a 0 to 100 scale. The total score ranges from a minimum of 0 to a maximum of 100. Higher scores indicate better health-related quality of life and a better outcome.
Measured: corrected age 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- UNIST (Ulsan National Institute of Science and Technology), Samsung Medical Center, Kangbuk Samsung Hospital, Asan Medical Center, Pusan National University Yangsan Hospital, Chungnam National University Hospital, Chung-Ang University Hospital, Seoul National University Bundang Hospital
- Responsible party
- Principal investigator, Woo Hyung Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882199
- Sponsor's protocol ID
- 2607-151-1770
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Video-based, Parent-centered Home Developmental Intervention for Infants at High Risk for Developmental Delay: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07882199
- Acronym / sponsor ID
- 2607-151-1770
- Conditions
- Preterm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- UNIST (Ulsan National Institute of Science and Technology), Samsung Medical Center, Kangbuk Samsung Hospital, Asan Medical Center, Pusan National University Yangsan Hospital, Chungnam National University Hospital, Chung-Ang University Hospital, Seoul National University Bundang Hospital
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the Motor Composite Score on the Bayley-III (administered at 6 months of corrected age) shows significant improvement in an intervention group-receiving usual care combined with a video-based home developmental intervention-compared to a control group receiving only usual care, among infants at high risk for developmental delay. The study subjects are infants discharged from the Neonatal Intensive Care Unit (NICU) who were born prematurely at a gestational age of less than 32 weeks or who sustained brain injury. The control group receives usual care only, while the intervention group receives usual care plus a parent-centered developmental training intervention. Parent education for this intervention involves 1:1 monitoring via video conferencing platforms to facilitate parent-centered early intervention at home; sessions last 30 minutes and are conducted once weekly from 0 to 3 months of corrected age and twice weekly from 4 to 6 months of corrected age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | – |
| Usual care + Family-centered developmental training intervention | Experimental | Other: Family-centered developmental training intervention |
Who may qualify
- Ages
- 0 weeks to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm infants born at less than 32 weeks of gestation
- Presence of brain injury confirmed via brain imaging (e.g., cranial ultrasound, brain MRI)
Key exclusion criteria (7 listed)
- Premature infants with a corrected age exceeding one month
- Presence of seizures uncontrolled by medication
- Presence of multiple or genetic malformations
- Presence of severe visual or auditory impairment
- Impaired level of consciousness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-centered developmental training interventionIn parent-centered developmental training interventions, parents administer developmental training to their infants at home, focusing on specific tasks selected by a therapist from a range of activities-such as motor play, look and see play, tactile play, and verbal play. Up to four tasks may be selected per day, with specific parameters regarding sessions, sets, and repetitions determined by medical staff or therapists based on the infant's performance. The program is implemented seven days a week. | Other | Usual care + Family-centered developmental training intervention |
Primary outcome
Bayley-III Motor Composite Score
Time frame: corrected 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.
56 secondary outcomes
General Movement Optimality Score-Revised
Time frame: baseline
General Movement Optimality Score-Revised
Time frame: corrected age 6 weeks
Bayley-III Cognitive Composite Score
Time frame: corrected age 6 months
Bayley-III Cognitive Composite Score
Time frame: corrected age 9 months
Bayley-III Cognitive Composite Score
Time frame: corrected age 18 months
Bayley-III Cognitive Composite Score
Time frame: corrected age 24 months
Bayley-III Cognitive Composite Score
Time frame: corrected age 36 months
Motor Optimality Score-Revised
Time frame: corrected age 3 months
Gross Motor Function Measure
Time frame: corrected age 6 months
Gross Motor Function Measure
Time frame: corrected age 9 months
Gross Motor Function Measure
Time frame: corrected age 18 months
Gross Motor Function Measure
Time frame: corrected age 24 months
Gross Motor Function Measure
Time frame: corrected age 36 months
Hammersmith Infant Neurological Examination
Time frame: corrected age 3 months
Hammersmith Infant Neurological Examination
Time frame: corrected age 6 months
Hammersmith Infant Neurological Examination
Time frame: corrected age 9 months
Hammersmith Infant Neurological Examination
Time frame: corrected age 18 months
Infant Sensory Profile
Time frame: baseline
Infant Sensory Profile
Time frame: corrected age 6 weeks
Infant Sensory Profile
Time frame: corrected age 3 months
Infant Sensory Profile
Time frame: corrected age 6 months
Toddler Sensory Profile
Time frame: corrected age 9 months
Toddler Sensory Profile
Time frame: corrected age 18 months
Toddler Sensory Profile
Time frame: corrected age 24 months
Child Sensory Profile
Time frame: corrected age 36 months
Parent Health Questionnaire-9
Time frame: baseline
Parent Health Questionnaire-9
Time frame: corrected age 6 weeks
Parent Health Questionnaire-9
Time frame: corrected age 3 months
Parent Health Questionnaire-9
Time frame: corrected age 6 months
Parent Health Questionnaire-9
Time frame: corrected age 18 months
Parent Health Questionnaire-9
Time frame: corrected age 24 months
Parent Health Questionnaire-9
Time frame: corrected age 36 months
Parenting Sense of Competence
Time frame: baseline
Parenting Sense of Competence
Time frame: corrected age 6 weeks
Parenting Sense of Competence
Time frame: corrected age 3 months
Parenting Sense of Competence
Time frame: corrected age 6 months
Parenting Sense of Competence
Time frame: corrected age 9 months
Parenting Sense of Competence
Time frame: corrected age 18 months
Parenting Sense of Competence
Time frame: corrected age 24 months
Parenting Sense of Competence
Time frame: corrected age 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Family-centered developmental training intervention in people with Preterm, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley-III Motor Composite Score (time frame: corrected age 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.