Evaluation of Digital Follow up of Preterm Infants

NCT05238168 | Unknown

• 1 other identifier: T200/2018
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Preterm Birth; Development Delay; Sensory Disorder; Growth Disorders; Family Relations

Keywords

Preterm infant; Digital follow up; Electronic health monitoring

Outcome Measures

Primary Outcomes (2)

• 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

• Response rate

  How many families responded at each time point

  0-28 months

Secondary Outcomes (1)

• Parent satisfaction Questionnaire

  0-28 months

Interventions

ePIPARI digital follow up tool OTHER

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.

Eligibility Criteria

• Age: 1 Month - 28 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Parents do not speak Finnish, Swedish or English

Sponsors & Collaborators

• Turku University Hospital: lead
• University of Turku: collaborator
• University of Helsinki: collaborator

Study Sites (1)

NICU/Pediatrics

Turku, 20500, Finland

RECRUITING

Related Publications (1)

• Saarinen T, Ylijoki M, Lehtonen L, Munck P, Stolt S, Lapinleimu H, Rautava P, Haataja L, Setanen S, Leppanen M, Huhtala M, Saarinen K, Gronroos L, Korja R; PIPARI Study group. Web-based follow-up tool (ePIPARI) of preterm infants-study protocol for feasibility and performance. BMC Pediatr. 2023 Aug 23;23(1):413. doi: 10.1186/s12887-023-04226-4.

  PMID: 37612695 DERIVED

MeSH Terms

Conditions

Premature Birth; Learning Disabilities; Sensation Disorders; Growth Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Pathologic Processes

Study Officials

• Liisa Lehtonen, MD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liisa Lehtonen, MD

CONTACT

+358408318322; lianle@utu.fi

Milla Ylijoki, MD

CONTACT

+358440781455; mikare@utu.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: January 1, 2019
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: April 19, 2022

Record last verified: 2022-04

Locations

FI (1)