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

Samsung Medical Center

Status

Not yet enrolling

Conditions

Preterm

Parents

Developmental Delay

Extreme Prematurity

Home Exercise

Early Intervention

Motor Outcome

Treatments

Other: Home Based Early Intervention by Parent

Study type

Interventional

Funder types

Other

Identifiers

NCT05334550

2022-02-28

Details and patient eligibility

About

This study is to prove the effectiveness of home based early intervention of extremely premature infant by Parent.

Full 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

Enrollment

110 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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