Evaluation of Digital Follow up of Preterm Infants

Preterm Birth Clinical Trial

— ePIPARI  

Official title:

ePIPARI - Digital Follow-up of Preterm Infants During First Two Years

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05238168
• Other study ID #: T200/2018
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2022
• Source: Turku University Hospital
• Contact: Liisa Lehtonen, MD
• Phone: +358408318322
• Email: lianle[@]utu.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 28 Months

Eligibility

Inclusion Criteria:

• Children born before 34 weeks fo gestation and their parents

• Clinical follow up at Turku University Hospital

Exclusion Criteria:

• Parents do not speak Finnish, Swedish or English

Related Conditions & MeSH terms

• Development Delay
• Disease
• Family Relations
• Growth Disorders
• Premature Birth
• Preterm Birth
• Sensation Disorders
• Sensory Disorder

Intervention

Other:
• ePIPARI digital follow up tool
A digital platform includes questions to parents about child wellbeing and development and parent wellbeing. A notification by email or app comes two weeks before the follow up time point. The parents respond via a link to a webpage or via an app.They also receive information (text and video) about age-appropriate child development. ePIPARI includes 8 assessment points from term age until 2 years of corrected age.

Locations

Country	Name	City	State
Finland	NICU/Pediatrics	Turku

Sponsors (3)

Lead Sponsor	Collaborator
Turku University Hospital	University of Helsinki, University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to identify children and parents in need for further support/interventions questionnaire	Digital follow up tool is compared to clinical follow up	0-28 months
Primary	Response rate	How many families responded at each time point	0-28 months
Secondary	Parent satisfaction Questionnaire	Questionnaire at each time point after the digital follow up and anonymous once yearly	0-28 months