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Not yet recruitingNCT07882199Updated Oct 20, 2026

Efficacy of a Video-based, Parent-centered Home Developmental Intervention for Infants at High Risk for Developmental Delay: a Multicenter Randomized Controlled Trial

An interventional study of Family-centered developmental training intervention in Preterm, sponsored by Seoul National University Hospital. Not yet recruiting. Open to participants aged 0 Weeks to 1 Month. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

Updated Oct 20, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
0 Weeks to 1 Month
Sex
All
01

Study 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 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.

02

Conditions studied

  • Preterm

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03

In context

Premature Birth

2,610 studies on the registry are indexed under Premature Birth; 507 are open to participants now.

This study's planned enrollment of 170 is above the median of 84 across 1,722 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,897 studies on the registry; 273 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Weeks to 1 Month
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Preterm infants born at less than 32 weeks of gestation
  • Presence of brain injury confirmed via brain imaging (e.g., cranial ultrasound, brain MRI)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
170 participants (estimated)

Study arms

  • No intervention
    Usual Care
  • Experimental
    Usual care + Family-centered developmental training intervention

    Other: Family-centered developmental training intervention

Interventions

  • OtherFamily-centered developmental training intervention

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: corrected age 6 months

Secondary outcomes

  1. 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.

    Time frame: baseline

  2. 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.

    Time frame: corrected age 6 weeks

  3. 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.

    Time frame: corrected age 6 months

  4. 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.

    Time frame: corrected age 9 months

  5. 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.

    Time frame: corrected age 18 months

  6. 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.

    Time frame: corrected age 24 months

  7. 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.

    Time frame: corrected age 36 months

  8. 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.

    Time frame: corrected age 3 months

  9. 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.

    Time frame: corrected age 6 months

  10. 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.

    Time frame: corrected age 9 months

  11. 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.

    Time frame: corrected age 18 months

  12. 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.

    Time frame: corrected age 24 months

  13. 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.

    Time frame: corrected age 36 months

  14. 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.

    Time frame: corrected age 3 months

  15. 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.

    Time frame: corrected age 6 months

  16. 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.

    Time frame: corrected age 9 months

  17. 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.

    Time frame: corrected age 18 months

  18. 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).

    Time frame: baseline

  19. 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).

    Time frame: corrected age 6 weeks

  20. 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).

    Time frame: corrected age 3 months

  21. 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).

    Time frame: corrected age 6 months

  22. 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).

    Time frame: corrected age 9 months

  23. 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).

    Time frame: corrected age 18 months

  24. 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).

    Time frame: corrected age 24 months

  25. 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).

    Time frame: corrected age 36 months

  26. 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.

    Time frame: baseline

  27. 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.

    Time frame: corrected age 6 weeks

  28. 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.

    Time frame: corrected age 3 months

  29. 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.

    Time frame: corrected age 6 months

  30. 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.

    Time frame: corrected age 18 months

  31. 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.

    Time frame: corrected age 24 months

  32. 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.

    Time frame: corrected age 36 months

  33. 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.

    Time frame: baseline

  34. 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.

    Time frame: corrected age 6 weeks

  35. 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.

    Time frame: corrected age 3 months

  36. 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.

    Time frame: corrected age 6 months

  37. 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.

    Time frame: corrected age 9 months

  38. 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.

    Time frame: corrected age 18 months

  39. 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.

    Time frame: corrected age 24 months

  40. 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.

    Time frame: corrected age 36 months

  41. 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.

    Time frame: baseline

  42. 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.

    Time frame: corrected age 6 weeks

  43. 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.

    Time frame: corrected age 3 months

  44. 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.

    Time frame: corrected age 6 months

  45. 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.

    Time frame: corrected age 9 months

  46. 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.

    Time frame: corrected age 18 months

  47. 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.

    Time frame: corrected age 24 months

  48. 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.

    Time frame: corrected age 36 months

  49. 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.

    Time frame: baseline

  50. 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.

    Time frame: corrected age 6 weeks

  51. 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.

    Time frame: corrected age 3 months

  52. 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.

    Time frame: corrected age 6 months

  53. 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.

    Time frame: corrected age 9 months

  54. 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.

    Time frame: corrected age 18 months

  55. 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.

    Time frame: corrected age 24 months

  56. 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.

    Time frame: corrected age 36 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 21, 2026

Documents are hosted by the registry — open the source record to download them.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Nov 2027, 11 months later.

Of 753 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 11 months is below that.

Counting every sponsor, half of 775 studies reached it within 24 months; a quarter within 12 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2026
First posted
Oct 20, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Nov 30, 2027
CompletionEst.
Dec 30, 2027
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07882199
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
Woo Hyung Lee (Associate Professor, Seoul National University Hospital) — Principal investigator
First posted
Oct 20, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Nov 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Oct 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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