Evaluation of Digital Follow up of Preterm Infants

Recruiting

• Conditions: Growth Disorders; Family Relations; Preterm Birth; Development Delay; Sensory Disorder

• Registration Number: NCT05238168
• Lead Sponsor: Turku University Hospital

Brief Summary

The aim is to study how a digital follow up tool can identify the preterm born children and their families who need further support or clinical interventions

Detailed Description

This study runs a digital follow up parallel to clinical follow up, up to 2 years of corrected age of the child. It evaluates the ability of the digital follow up tool to identify the problems in growth and health, eating and feeding, neurodevelopment and parental wellbeing which require further support or interventions. This study includes all infants born under 34 weeks of gestation in Turku University Hospital during years 2019-2022 and those preterm children born under 32 weeks of gestation who turn to 2 years during years 2019-2021.

Parent satisfaction about the digital follow up tool is asked at each time point and anonymously once per year. The follow up age points are the expected day of birth, 1 month, 2 months, 4 months, 8 months, 12 months, 18 months and 24 months after the expected birth date.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-11
• Study First Posted: 2022-02-14
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-19
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Children born before 34 weeks fo gestation and their parents
• Clinical follow up at Turku University Hospital

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Exclusion Criteria

• Parents do not speak Finnish, Swedish or English

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate	0-28 months	How many families responded at each time point
Ability to identify children and parents in need for further support/interventions questionnaire	0-28 months	Digital follow up tool is compared to clinical follow up

Secondary Outcome Measures

Name	Time	Method
Parent satisfaction Questionnaire	0-28 months	Questionnaire at each time point after the digital follow up and anonymous once yearly

Trial Locations

Locations (1)

NICU/Pediatrics; 🇫🇮 Turku, Finland