Preterm BirthePIPARINCT05238168
Evaluation of Digital Follow up of Preterm Infants
An observational study of Preterm Birth and Development Delay, run by Turku University Hospital at 1 site in Finland.
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 Read more about this study
- Who is it for?
- Ages 1 month to 28 months
- Conditions the study is for
- Preterm Birth, Development Delay, Sensory Disorder
- What is being tested?
- ePIPARI digital follow up tool
- How many people
- 70 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2019to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 28 months
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants treated in a neonatal intensive care unit and their parents.
Who may be able to join
- Children born before 34 weeks fo gestation and their parents
- Clinical follow up at Turku University Hospital
Who cannot join
- Parents do not speak Finnish, Swedish or English
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
NICU/Pediatrics
Turku, 20500
NICU/Pediatrics, +358408318322, liisa.lehtonen@tyks.fi
About this study
Official title: 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
Read the 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.
- Being tested
- ePIPARI digital follow up tool
- Keywords
- Preterm infant, Digital follow up, Electronic health monitoring
- Medical subject headings
- Premature Birth, Learning Disabilities, Sensation Disorders, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePIPARI digital follow up toolOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to identify children and parents in need for further support/interventions questionnaire
Digital follow up tool is compared to clinical follow up
Measured: 0-28 months
Response rate
How many families responded at each time point
Measured: 0-28 months
Secondary outcomes (1)
Parent satisfaction Questionnaire
Questionnaire at each time point after the digital follow up and anonymous once yearly
Measured: 0-28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Jan 2019
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku, University of Helsinki
- Responsible party
- Principal investigator, Liisa Lehtonen, Turku University Hospital
- Investigators
- Liisa Lehtonen, MD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238168
- Sponsor's protocol ID
- T200/2018
- Acronym
- ePIPARI
- Status last verified
- Apr 2022
- First submitted
- 3 Feb 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37612695
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ePIPARI - Digital Follow-up of Preterm Infants During First Two Years
- ClinicalTrials.gov ID
- NCT05238168
- Acronym / sponsor ID
- ePIPARI / T200/2018
- Keywords
- Preterm infant, Digital follow up, Electronic health monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Turku, University of Helsinki
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 28 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants treated in a neonatal intensive care unit and their parents.
Key inclusion criteria (2 listed)
- Children born before 34 weeks fo gestation and their parents
- Clinical follow up at Turku University Hospital
Key exclusion criteria (1 listed)
- Parents do not speak Finnish, Swedish or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ePIPARI digital follow up toolA 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. | Other | – |
Primary outcome
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
Response rate
Time frame: 0-28 months
How many families responded at each time point
1 secondary outcome
Parent satisfaction Questionnaire
Time frame: 0-28 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Derived from this study: PubMed 37612695Saarinen 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.
Related trials for Preterm Birth
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liisa Lehtonen, MD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Development Delay, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liisa Lehtonen, MD (+358408318322, lianle@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to identify children and parents in need for further support/interventions questionnaire (time frame: 0-28 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05238168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.