Early Detection and Prevention of Health Complications in Premature Infants - Early Detection of Developmental Abnormalities of Preterm Infants at 5 Years of Age
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Institute of Health Information and Statistics of the Czech Republic
- Enrollment
- 210
- Locations
- 4
- Primary Endpoint
- Proportion of premature infants with identified pathology at 5 years (overall, by detected pathology)
Overview
Brief Summary
The project is a national, prospective, multicenter, interventional pilot project focused on the follow up of 5 year old children that were born prematurely.
The primary aim of the project is to prepare, test, and develop a proposal for a national methodology for the care of children born prematurely. This will minimize the negative impacts on the overall development of the child and the family of the prematurely born children.
Detailed Description
The project is a national, prospective, multicenter, interventional pilot project focused on the follow up of 5 year old children that were born prematurely.
The main goal of the project is establishing a methodology for the long-term monitoring of premature infants (in the area of developmental anomalies) and their evaluation at the age of 5 years.
The main objective of this activity is to validate this screening process, which will benefit 210 patients in 2 perinatal and 2 intermediate centers. The child will undergo a comprehensive pediatric examination, including basic vision, speech, and psychomotoric assessments (MABC-2 and IDS-P). If any concerns are identified, the child will be referred to an appropriate specialist. The timeliness of this check-up has significant positive impact on both the patient and their family.
The project is supported by the European Social Fund (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0002020.
The study has been reviewed and approved by multiple local ethical committees. The listed IRB represents the lead national ethical committee overseeing the trial.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed consent for participation in the project and consent for the processing of personal data.
- •Children born before 37 weeks of gestation, aged 5 years, growing up in a Czech-speaking environment.
- •To ensure valid linkage of all data sources, the children must have been born to parents with Czech citizenship.
Exclusion Criteria
- •Unsigned consent for participation in the project and consent for the processing of personal data.
- •Severe psychomotor retardation .
- •Severe congenital malformations.
Arms & Interventions
5 year old children born prematurely
Intervention: Pediatric check-up (Other)
Outcomes
Primary Outcomes
Proportion of premature infants with identified pathology at 5 years (overall, by detected pathology)
Time Frame: During study participation (up to 3 days)
Proportion of premature infants referred to a specialized center (overall, by detected pathology)
Time Frame: During study participation (up to 3 days)
Secondary Outcomes
No secondary outcomes reported