Evaluation of Digital Follow up of Preterm Infants (ePIPARI)

April 11, 2022 updated by: Liisa Lehtonen, Turku University Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Liisa Lehtonen, MD
  • Phone Number: +358408318322
  • Email: lianle@utu.fi

Study Contact Backup

  • Name: Milla Ylijoki, MD
  • Phone Number: +358440781455
  • Email: mikare@utu.fi

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Preterm infants treated in a neonatal intensive care unit and their parents.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent satisfaction Questionnaire
Time Frame: 0-28 months
Questionnaire at each time point after the digital follow up and anonymous once yearly
0-28 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Collaborators

University of Turku
University of Helsinki

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

April 30, 2025

Study Completion (Anticipated)

April 30, 2025

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

February 11, 2022

First Posted (Actual)

February 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 11, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T200/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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