ePIPARI: Evaluation of Digital Follow up of Preterm Infants

• Sponsor: Turku University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05238168
• Collaborator: University of Turku (Other), University of Helsinki (Other)
• Enrollment: 70
• Location: 1
• Anticipated Duration (Months): 75.9
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth; Development Delay; Sensory Disorder; Growth Disorders; Family Relations	Other: ePIPARI digital follow up tool

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 Design

• Study Type: Observational
• Anticipated Enrollment: 70 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: ePIPARI - Digital Follow-up of Preterm Infants During First Two Years
• Actual Study Start Date: Jan 1, 2019
• Anticipated Primary Completion Date: Apr 30, 2025
• Anticipated Study Completion Date: Apr 30, 2025

Outcome Measures

Primary Outcome Measures

1. 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

2. Response rate [0-28 months]

   How many families responded at each time point

Secondary Outcome Measures

1. Parent satisfaction Questionnaire [0-28 months]

   Questionnaire at each time point after the digital follow up and anonymous once yearly

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 28 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NICU/Pediatrics	Turku		Finland	20500

Sponsors and Collaborators

• Turku University Hospital
• University of Turku
• University of Helsinki

Investigators

• Principal Investigator: Liisa Lehtonen, MD, Turku University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Liisa Lehtonen, Professor, Turku University Hospital
• ClinicalTrials.gov Identifier: NCT05238168
• Other Study ID Numbers: T200/2018
• First Posted: Feb 14, 2022
• Last Update Posted: Apr 19, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Liisa Lehtonen, Professor, Turku University Hospital: Preterm infant; Digital follow up; Electronic health monitoring
• Additional relevant MeSH terms: Sensation Disorders; Premature Birth; Disease; Growth Disorders

Study Results

No Results Posted as of Apr 19, 2022