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

Study Overview
=================
Brief Summary
-----------------
This study is to prove the effectiveness of home based early intervention of extremely premature infant by Parent.

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

Official Title
-----------------
Effectiveness of Home Based Early Intervention of Extremely Premature Infant by Parent

Conditions
-----------------
Preterm, Extreme Prematurity, Early Intervention, Developmental Delay, Motor Outcome, Home Exercise, Parents

Intervention / Treatment
-----------------
* Other: Home Based Early Intervention by Parent


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Allocated to intervention group through randomization process. | Other: Home Based Early Intervention by Parent<br>* 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.<br>|
| No Intervention: Control group<br>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 | 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 | 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 | 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 | 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 |