Care Outcomes in Preterm Infants Following the Implementation of Family-centered Interventions

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.

Study Overview

• Status: Recruiting
• Conditions: Prematurity

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 Type: Observational
• Enrollment (Anticipated): 30000

Contacts and Locations

• Study Contact: Name: Kjell Helenius, MD, PhD; Phone Number: +358405597347; Email: kkhele@utu.fi

Study Locations

• Finland
  • Turku, Finland, 20521
    • Recruiting
    • University of Turku
    • Contact: Liisa Lehtonen, Professor; Phone Number: +35823130253; Email: lianle@utu.fi
    • Contact: Kjell Helenius, MD, PhD; Phone Number: +35823133422; Email: kkhele@utu.fi
    • Sub-Investigator: Kjell Helenius, PhD, MD
    • Sub-Investigator: Sari Ahlqvist-Björkroth, PhD
    • Sub-Investigator: Anna Axelin, Professor
    • Sub-Investigator: Ryo Itoshima, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Complete preterm birth cohort included in the national Medical Birth Register

Description

Inclusion Criteria:

• Preterm infants (gestational age <35 weeks) born in Finland between 2006 and 2020

Exclusion Criteria:

• Missing data on key variables (gestational age, place of birth, length of stay)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	The length in days on the initial hospitalization following preterm birth	Immediately after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Kilograms	Immediately after discharge
Length	Centimeters	Immediately after discharge
Head circumference	Centimeters	Immediately after discharge
Postnatal emergency visits	Amount of unplanned emergency outpatient visits after discharge from initial hospitalization	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	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	Immediately after discharge

Collaborators and Investigators

• Sponsor: University of Turku
• Investigators: Principal Investigator: Liisa Lehtonen, Professor, Turku University Hospital and University of Turku

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Postnatal growth; Length of stay; Neonatal intensive care; Infant, preterm
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: VVM_LOS_2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No