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

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Seoul National University

Status

Invitation-only

Conditions

Very Low Birth Weight Infants
Premature Infants

Treatments

Other: Parent-centered developmental training

Study type

Interventional

Funder types

Other

Identifiers

NCT06965842
0420222050

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

Under 1 month old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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)

Exclusion criteria

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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

intervention
Experimental group
Treatment:
Other: Parent-centered developmental training

Trial contacts and locations

1

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Central trial contact

Soohyun Wi, PhD

Data sourced from clinicaltrials.gov

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