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Premature InfantsNCT06965842

The Video System to Provide a Developmental Training Guide for Preterm Infants

A study testing Parent-centered developmental training in people with Premature Infants and Very Low Birth Weight Infants, run by Seoul National University Hospital at 1 site in South Korea.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This study aimed to establish a systematic developmental training guide protocol for parent-centered early intervention and verify the concept and feasibility of a video system for parent-centered in-home developmental therapy under the monitoring of a therapist. Read more about this study

Who is it for?
Ages Up to 1 month
What is being tested?
Parent-centered developmental training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSouth Korea
Study dates
24 Jun 2025to 30 Jan 2028
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 Up to 1 month
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Premature infants less than 32 weeks of gestation or extremely low birth weight infants less than 1500 g
  • Premature infants with a corrected age of less than 1 month
  • Brain damage through brain imaging (e.g. cranial USG, brain MRI)

Who cannot join

  • Multiple malformations or genetic abnormalities
  • Severe visual or hearing impairment
  • Loss of consciousness
  • Tracheostomy
  • Medically unstable condition

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site

  • Seoul National University Hospital

    Seoul, Jongno-gu, 03080

Other trials in South Korea

About this study

Official title: The Video System to Provide a Developmental Training Guide for In-home, Parent-centered, Early Intervention in Preterm Infants: A Proof of Concept and Feasibility Study

This study aimed to establish a systematic developmental training guide protocol for parent-centered early intervention and verify the concept and feasibility of a video system for parent-centered in-home developmental therapy under the monitoring of a therapist. The target group is premature infants under 32 weeks of gestation or very low birth weight infants under 1500 g with brain damage. A single-arm intervention group of 10 people was recruited, and considering a dropout rate of 20%, the total number of participants was calculated to be 12. 1:1 monitoring to provide parent-centered early intervention at home after discharge from the neonatal intensive care unit is conducted twice a week for 30 minutes per session using a video platform (Zoom) until the corrected age of 6 months. Parents record the developmental training process using a smartphone and transmit it to the therapist, who analyzes the video data to provide new treatment goals and guidelines. Feasibility assessment included: 1) Exercise diary: Number of total and average sessions performed (N) and percentage (%), number of total and average sessions completed (N) and percentage (%) 2) Parent questionnaire 3) Video analysis: Periodic video education and developmental training video acquisition and analysis 4) Heart rate analysis: Analysis of average heart rate during and after rest and developmental training 5) Safety analysis: Number of times (N) and reasons for exercise interruption during developmental training 6) Developmental assessment: Implementation of developmental assessments such as GMOS, MOS-R, HINE, GMFM, and BSID. For safety assessment, if the following symptoms appear during development training, stop exercising and rest until stable. If oxygen saturation drops by more than 10% compared to resting, causing cyanosis and dyspnea, or if heart rate increases by more than 150 beats/min.

Being tested
Parent-centered developmental training
Keywords
developmental training, premature infants, very low birth weight infants, early 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.

  • Parent-centered developmental trainingOther

    After discharge from the neonatal intensive care unit, 1:1 monitoring is conducted at home for 30 minutes twice a week using a video conferencing platform (Zoom) until the corrected age of 6 months to provide parent-centered early intervention. Parents film the developmental training process using a smartphone and send the video to the therapist, who analyzes the video data to provide new treatment goals and guidelines.

Study groups in NCT06965842
Study groupRoleWhat they receive
interventionExperimentalNot described
Receives: Other: Parent-centered developmental training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of total and average sessions performed (N)

    Measured: up to corrected age 6 months

  2. Percentage of total and average sessions performed (%)

    Measured: up to corrected age 6 months

  3. Number of total and average sessions completed (N)

    Measured: up to corrected age 6 months

  4. Percentage of total and average sessions completed (%)

    Measured: up to corrected age 6 months

  5. Parent questionnaire

    Measured: at corrected age 6 months

  6. General Movement Optimality Score

    Minimum score: 5 Maximum score: 42 Assessing the quality of writhing movements in infants (typically from term age to 6-9 weeks post-term). Higher scores reflect more optimal general movements - smooth, variable, and age-appropriate. Lower scores may suggest abnormal or poor-quality movements, which are associated with neurological risk.

    Measured: corrected age 0, 1.5months

  7. Motor Optimality Score-Revised

    Minimum score: 5 Maximum score: 28

    Evaluating fidgety movements and other spontaneous motor patterns in infants (typically from 9 to 20 weeks post-term). Higher scores indicate better motor repertoire and neurological function, and are associated with typical development. Lower scores are often seen in infants at risk for motor disorders, such as cerebral palsy.

    Measured: corrected age 4months

  8. Hammersmith Infant Neurological Examination

    Total Score Range:

    Minimum: 0 Maximum: 78

    The total score is the sum of scores across 26 items, each scored from 0 to 3:

    0 = severely abnormal

    1. = moderately abnormal
    2. = mildly abnormal
    3. = normal Higher HINE scores (closer to 78) indicate better neurological function. Lower scores may suggest neurological impairment or risk for conditions such as cerebral palsy.

    Measured: corrected age 4, 6, 9 months

  9. Gross Motor Function Measure

    GMFM-88

    Items: 88 items across 5 dimensions:

    Lying and Rolling Sitting Crawling and Kneeling Standing Walking, Running, and Jumping Scoring per item: 0 to 3

    Total Score Range:

    Minimum: 0% Maximum: 100% (Expressed as a percentage of the maximum possible score) Higher scores represent better gross motor function.

    Measured: corrected age 6, 9 months

  10. Bayley Scales of Infant and Toddler Development

    1. Scaled Scores (for subtests like Fine Motor, Expressive Language, etc.): Range: Minimum: 1 Maximum: 19 Mean: 10 Standard Deviation (SD): 3
    2. Composite Scores (for broader domains like Cognitive, Motor, etc.):

    Range:

    Minimum: 40 Maximum: 160 Mean: 100 Standard Deviation (SD): 15 130 and above Very Superior 120-129 Superior 110-119 High Average 90-109 Average 80-89 Low Average 70-79 Borderline Below 70 Extremely Low / Delayed

    Measured: corrected age 9 months

  11. Number of exercise interruption (N)

    Measured: up to corrected age 6 months

  12. Number of adverse event (N)

    Measured: up to corrected age 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2025
  2. Study start24 Jun 2025
  3. Primary completion30 Jan 2026 (estimated)
  4. Study completion30 Jan 2028 (estimated)

Resources

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
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06965842
Sponsor's protocol ID
0420222050
Status last verified
Sep 2025
First submitted
21 Apr 2025
Last updated
17 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Parent-centered developmental training in people with Premature Infants and Very Low Birth Weight Infants, run by Seoul National University Hospital at 1 site in South Korea.

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 3 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Number of total and average sessions performed (N) (time frame: up to corrected age 6 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06965842.

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 17 Sep 2025.

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