Effectiveness of Home Based Early Intervention of Extremely Premature Infant by Parent

June 3, 2022 updated by: Jeong Yi Kwon, Samsung Medical Center
This study is to prove the effectiveness of home based early intervention of extremely premature infant by Parent.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The perpose of this study to prove the significance of the hypothesis that there will be a significant improvement in motor development when remote tele-rehabilitation treatment is performed for extremely premature infants. The investigators plan to recruit subjects who meet the inclusion criteria and do not meet the exclusion criteria from among extremely premature infants born at Samsung Hospital, Seoul, Korea, whose gestational age is from 23 weeks to 28 weeks. The target number of n is 110, 55 per group. After randomization into an intervention group and a control group, the intervention group get the intervention starting at 0 months of correctional age and runs for 3 months. In both groups, motor outcomes are measured at the time of enrollment, at 3 months of correction age, 6 months of correction age and 12 months of correction age

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Extreme premature baby (gestationl age 23~28 weeks)
  • Corrected age under one month at the time of enroll of this study
  • Children of those who voluntarily decided to participate after hearing detailed explanations about this study and gave their written consent.
  • Children whose parents are Korean

Exclusion Criteria:

  • Congenital anomalies in the central nervous system
  • Hereditary diseases
  • Chromosomal abnormalities (Down syndrome, etc.)
  • Stage 3 or more intraventricular hemorrhage
  • If surgery was performed for hydrocephalus
  • Leukomalacia confirmed by ultrasound examination (not applicable to increase in white matter shading)
  • Neonatal asphyxia
  • Other central nervous system diseases
  • If taking medications for convulsions or epilepsy
  • Metabolic disease
  • In the case of premature infants undergoing surgery for retinal disease
  • Hearing loss
  • In case of surgery due to complex congenital anomaly or planned operation (not excluded if surgery is not required)
  • In case of oxygen dependence due to lung disease in premature infants
  • Musculoskeletal disorders (hip dislocation, polyarthrosis, etc.)
  • Neuromuscular disease, etc.
  • Those whose family has social problems
  • Those whose parents cannot participate in this study
  • Those who have other serious complications that cannot proceed with the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Allocated to intervention group through randomization process.
Other: Home Based Early Intervention by Parent
Through a video communication program called ZOOM, the parents of intervention group are educated once every two weeks for three months. Parent education consists of a program developed by our pediatric rehabilitation therapist to help premature infants develop motor skills. Parents provide daily exercise training to their children as educated.
No Intervention: Control group
Allocated to control group through randomization process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Test of infant motor performance at 3 months
Time Frame: around the start of intervention(up to 1 week), 3 months after the start of intervetion
The Test of infant motor performance (TIMP) is conducted on infants under 4 months of age to perform functions in daily life. It is performed to evaluate the selective control of postures and movements that infants need in daily life, and takes an average of 25-35 minutes. The TIMP was developed to 1) identify infants with delayed motor development, 2) differentiate between infants with varying degrees of risk for measurement outcomes, and 3) measure changes due to interventions. Because it can be used in both early intervention programs, it can aid in communication between parents and health care providers in a variety of settings. The range of test score is from 0 to 142. The higher score means the better motor performance.
around the start of intervention(up to 1 week), 3 months after the start of intervetion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Edinburgh postnatal depression scale at 3 months
Time Frame: around the start of intervention(up to 1 week), 3 months after the start of intervetion
Edinburgh postnatal depression scale is a 10-item scale for screening for maternal depression. Each item is scored from 0 to 3; the higher score indicates the possibility of depressed status. Total score is from 0 to 30. A score of 13 or higher indicates a possible postpartum depression. It has been validated by several studies confirming that EPDS is a reliable and sensitive indicator of depression.
around the start of intervention(up to 1 week), 3 months after the start of intervetion
Alberta infant motor scale
Time Frame: 6 months and 12 months after the start of intervetion
Alberta infant motor scale is a validated and reliable observational tool for use in infants from full term to 18 months of age. Alberta infant motor scale can evaluate the qualitative aspects of movement and sensitively measure the change in infant's motor performance. Assessment of Alberta infant motor scale is scored based on the number of gross motor postures and movements the infant has demonstrated while prone, supine, and sitting or standing. The range of scores of each item are as followed; prone is from 0 to 21, supine is from 0 to 9, sitting is from 0 to 12, standing is from 0 to 16. The range of total score is from 0 to 58. The higher score means the better motor performance. The evaluation score can be converted to a percentile rank that can be compared with the percentile rank of a standard age-matched infant sample.
6 months and 12 months after the start of intervetion
Peabody Developmental Motor Scales 2nd edition
Time Frame: 12 months after the start of intervetion
Peabody Developmental Motor Scales 2nd edition evaluates both fine motor and macromotor function. It can be evaluated from newborn to 5 years old. It consists of six subtests: reflex, stationary, locomotion, object manipulation, grasping, and visual motor integration. Range of score of each items are as followed; reflex is from 0 to 16, stationary is from 0 to 60, locomotion is from 0 to 198, objective manipulation is from 0 to 48, grasping is from 0 to 26, visual-motor integration is from 0 to 72. The summation of scores is converted into age-matched percentile that can be ranked. The higher scores is matched to better ranked percentile. Peabody Developmental Motor Scales 2nd edition is a test whose reliability and validity have been verified in various conditions such as autism, cerebral palsy, and premature infants.
12 months after the start of intervetion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Kwon Jeong-Yi, PhD, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 2, 2022

Primary Completion (Anticipated)

March 2, 2023

Study Completion (Anticipated)

March 2, 2024

Study Registration Dates

First Submitted

March 2, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

June 8, 2022

Last Update Submitted That Met QC Criteria

June 3, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-02-28

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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