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

Prematurity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05765136
• Other study ID #: VVM_LOS_2021
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: May 2023

Study information

• Verified date: February 2023
• Source: University of Turku
• Contact: Kjell Helenius, MD, PhD
• Phone: +358405597347
• Email: kkhele[@]utu.fi
• Is FDA regulated: No
• Study type: Observational

Clinical 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 single-family room architecture.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

Locations

Country	Name	City	State
Finland	University of Turku	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay	The length in days on the initial hospitalization following preterm birth	Immediately after discharge
Secondary	Weight	Kilograms	Immediately after discharge
Secondary	Length	Centimeters	Immediately after discharge
Secondary	Head circumference	Centimeters	Immediately after discharge
Secondary	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
Secondary	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
Secondary	Gestational age at discharge	The corrected gestational age of the infant at final discharge from neonatal care	Immediately after discharge