PrematurityNCT05765136
Care Outcomes in Preterm Infants Following the Implementation of Family-centered Interventions
An observational study of Prematurity, run by University of Turku at 1 site in Finland.
Trial summary
The proposed study evaluates the effects of two family-centered interventions on the length of stay and outpatient visits and growth of preterm infants.The interventions are 1) the Close Collaboration with Parents training for the staff and 2) moving from traditional neonatal intensive care unit architecture to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prematurity
- How many people
- 30,000 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2021to May 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Complete preterm birth cohort included in the national Medical Birth Register
Who may be able to join
- Preterm infants (gestational age <35 weeks) born in Finland between 2006 and 2020
Who cannot join
- Missing data on key variables (gestational age, place of birth, length of stay)
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
University of Turku
Turku, 20521
Liisa Lehtonen, Professor, +35823130253, lianle@utu.fi
Kjell Helenius, MD, PhD, +35823133422, kkhele@utu.fi
About this study
Official title: The Effects of the Close Collaboration With Parents Training and Single-family Room Architecture on the Length of Stay and Growth Parameters of Preterm Infants - a National Multicenter Study in Finland
The proposed study evaluates the effects of two family-centered interventions on the length of stay and outpatient visits and growth of preterm infants.The interventions are 1) the Close Collaboration with Parents training for the staff and 2) moving from traditional neonatal intensive care unit architecture to single-family room architecture.
Read the detailed description
The Close Collaboration with Parents training targeted to the health care team of neonatal intensive care units to facilitate parental involvement in infant care and to support parenting. The training program involves a structured education process, where trained mentors educate staff in neonatal units. The duration of the training program is 18 months per unit. The training program has been implemented in eleven neonatal units in Finland since 2009; another 12 units haver not gone through the training.
The other intervention, single-family room architecture, provides facilities for parents to stay in the room of their infant throughout there 24 hour day. This intervention has been carried out in four neonatal units in Finland since 2014; in one by restructuring the existing unit, and in three by building a new unit/hospital.
In this study, the investigators are going to use national, population-based registers (the Medical Birth Register, the small Preterm Infant Register and the Hospital Discharge Register) governed by the Finnish National Institute for Health and Welfare. These registers have been widely used for observational studies, and contain data on all newborn infants in the country.
There are currently 23 neonatal units in Finland. Three units have undergone both interventions, nine units have undergone one intervention, and 12 units have undergone neither. Preterm infants (born before 35 gestational weeks) discharged from any unit will be divided into those who have been cared for all, part or no time in a hospital with an intervention, separately for each intervention. The outcome measures of interest will be related to health care utilization such as the length of stay and unscheduled outpatient visits, and to clinical outcomes such as postnatal growth parameters.
- Conditions
- Prematurity
- Keywords
- Infant, preterm, Length of stay, Neonatal intensive care, Postnatal growth
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Close collaboration group | Preterm infants born in hospitals where the Close Collaboration with Parents training program has been successfully implemented | |
| Single-family room group | Preterm infants born in hospitals that have implemented an architectural change to single-family room design | |
| Control group | Preterm infants born in hospitals that have not gone through any of the two aforementioned interventions (single-family room architecture or Close Collaboration with Parents training program) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
The length in days on the initial hospitalization following preterm birth
Measured: Immediately after discharge
Secondary outcomes (6)
Weight
Kilograms
Measured: Immediately after discharge
Length
Centimeters
Measured: Immediately after discharge
Head circumference
Centimeters
Measured: Immediately after discharge
Postnatal emergency visits
Amount of unplanned emergency outpatient visits after discharge from initial hospitalization
Measured: Within the first year of life (corrected gestational age) after discharge home
Postnatal emergency hospitalizations
Duration of unplanned emergency outpatient hospitalizations after discharge from initial hospitalization
Measured: Within the first year of life (corrected gestational age) after discharge home
Gestational age at discharge
The corrected gestational age of the infant at final discharge from neonatal care
Measured: Immediately after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 Sep 2021
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Liisa Lehtonen, University of Turku
- Investigators
- Liisa Lehtonen, Professor, Principal investigator, Turku University Hospital and University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765136
- Sponsor's protocol ID
- VVM_LOS_2021
- Status last verified
- Feb 2023
- First submitted
- 1 Sep 2021
- Last updated
- 13 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Close Collaboration With Parents Training and Single-family Room Architecture on the Length of Stay and Growth Parameters of Preterm Infants - a National Multicenter Study in Finland
- ClinicalTrials.gov ID
- NCT05765136
- Acronym / sponsor ID
- VVM_LOS_2021
- Conditions
- Prematurity
- Keywords
- Infant, preterm, Length of stay, Neonatal intensive care, Postnatal growth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 13 Mar 2023 (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 proposed study evaluates the effects of two family-centered interventions on the length of stay and outpatient visits and growth of preterm infants.The interventions are 1) the Close Collaboration with Parents training for the staff and 2) moving from traditional neonatal intensive care unit architecture to single-family room architecture.
Detailed description
The Close Collaboration with Parents training targeted to the health care team of neonatal intensive care units to facilitate parental involvement in infant care and to support parenting. The training program involves a structured education process, where trained mentors educate staff in neonatal units. The duration of the training program is 18 months per unit. The training program has been implemented in eleven neonatal units in Finland since 2009; another 12 units haver not gone through the training.
The other intervention, single-family room architecture, provides facilities for parents to stay in the room of their infant throughout there 24 hour day. This intervention has been carried out in four neonatal units in Finland since 2014; in one by restructuring the existing unit, and in three by building a new unit/hospital.
In this study, the investigators are going to use national, population-based registers (the Medical Birth Register, the small Preterm Infant Register and the Hospital Discharge Register) governed by the Finnish National Institute for Health and Welfare. These registers have been widely used for observational studies, and contain data on all newborn infants in the country.
There are currently 23 neonatal units in Finland. Three units have undergone both interventions, nine units have undergone one intervention, and 12 units have undergone neither. Preterm infants (born before 35 gestational weeks) discharged from any unit will be divided into those who have been cared for all, part or no time in a hospital with an intervention, separately for each intervention. The outcome measures of interest will be related to health care utilization such as the length of stay and unscheduled outpatient visits, and to clinical outcomes such as postnatal growth parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Close collaboration group | – | –Preterm infants born in hospitals where the Close Collaboration with Parents training program has been successfully implemented |
| Single-family room group | – | –Preterm infants born in hospitals that have implemented an architectural change to single-family room design |
| Control group | – | –Preterm infants born in hospitals that have not gone through any of the two aforementioned interventions (single-family room architecture or Close Collaboration with Parents training program) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Complete preterm birth cohort included in the national Medical Birth Register
Key inclusion criteria (1 listed)
- Preterm infants (gestational age <35 weeks) born in Finland between 2006 and 2020
Key exclusion criteria (1 listed)
- Missing data on key variables (gestational age, place of birth, length of stay)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of stay
Time frame: Immediately after discharge
The length in days on the initial hospitalization following preterm birth
6 secondary outcomes
Weight
Time frame: Immediately after discharge
Length
Time frame: Immediately after discharge
Head circumference
Time frame: Immediately after discharge
Postnatal emergency visits
Time frame: Within the first year of life (corrected gestational age) after discharge home
Postnatal emergency hospitalizations
Time frame: Within the first year of life (corrected gestational age) after discharge home
Gestational age at discharge
Time frame: Immediately after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
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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, Professor principal investigator
Turku University Hospital and University of Turku
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 Prematurity, run by University of Turku 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 1 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 13 Mar 2023. 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 Kjell Helenius, MD, PhD (+358405597347, kkhele@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (time frame: Immediately after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2023.