Back to resultsEffectiveness of Home Based Early Intervention of Extremely Premature Infant by Parent
Primary Purpose
Preterm, Extreme Prematurity, Early Intervention
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home Based Early Intervention by Parent
Sponsored by
About this trial
This is an interventional treatment trial for Preterm
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Allocated to intervention group through randomization process.
Allocated to control group through randomization process.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05334550
Brief Title
Effectiveness of Home Based Early Intervention of Extremely Premature Infant by Parent
Official Title
Effectiveness of Home Based Early Intervention of Extremely Premature Infant by Parent
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2, 2022 (Anticipated)
Primary Completion Date
March 2, 2023 (Anticipated)
Study Completion Date
March 2, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm, Extreme Prematurity, Early Intervention, Developmental Delay, Motor Outcome, Home Exercise, Parents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Allocated to intervention group through randomization process.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Allocated to control group through randomization process.
Intervention Type
Other
Intervention Name(s)
Home Based Early Intervention by Parent
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Test of infant motor performance at 3 months
Description
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.
Time Frame
around the start of intervention(up to 1 week), 3 months after the start of intervetion
Secondary Outcome Measure Information:
Title
Change from baseline Edinburgh postnatal depression scale at 3 months
Description
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.
Time Frame
around the start of intervention(up to 1 week), 3 months after the start of intervetion
Title
Alberta infant motor scale
Description
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.
Time Frame
6 months and 12 months after the start of intervetion
Title
Peabody Developmental Motor Scales 2nd edition
Description
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.
Time Frame
12 months after the start of intervetion
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lee Jinuk, resident
Phone
+8210-4555-3349
Email
jinuk8780.lee@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kwon Jeong-Yi, PhD
Phone
+82-2-3410-2818
Email
jeongyi.kwon@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwon Jeong-Yi, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Home Based Early Intervention of Extremely Premature Infant by Parent
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