Clinical trial NCT05334550: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm
Extreme Prematurity
Early Intervention
Developmental Delay
Motor Outcome
Home Exercise
Parents
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change from baseline Test of infant motor performance at 3 months
timeFrame: around the start of intervention(up to 1 week), 3 months after the start of intervetion
Secondary outcomes:
measure: Change from baseline Edinburgh postnatal depression scale at 3 months
timeFrame: around the start of intervention(up to 1 week), 3 months after the start of intervetion
measure: Alberta infant motor scale
timeFrame: 6 months and 12 months after the start of intervetion
measure: Peabody Developmental Motor Scales 2nd edition
timeFrame: 12 months after the start of intervetion
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center
name: Kwon Jeong-Yi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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