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
Conditions: Prematurity
Sponsor: University of Turku

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ClinicalTrials.gov registration title page 
 
Official title of the study: 
The effect of the Close Collaboration with Parents-training program and single-family 
room architecture on length of stay and growth parameters in Finland  
 
Research group 
Ryo Itoshima, MD, research fellow1, Suvi Lähteenmäki, MSc (Econ)1, Kjell Helenius, MD, post-doctoral 
researcher1, Anna Axelin, PhD (Nurs), assistant professor2, Sari Ahlqvist-Björkroth, PhD, clinical 
lecturer3, Liisa Lehtonen, MD, PhD, professor in paediatrics1,4 
1Turku University Hospital, Department of Paediatrics and Adolescent Medicine 
2University of Turku, Department of Nursing Sciences 
3University of Turku, Department of Psychology 
4University of Turku, Department of Clinical Medicine, Paediatrics 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date of the document: November 30, 2020 

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Background 
In Europe, over 500,000 newborn infants are hospitalized each year. Infants are often separated from their 
parents during their hospitalization. One study showed that very preterm infants spent 80% of their time without 
any human contact (1). A European survey showed a large variation in parents’ presence between hospitals, 
starting from 2.6 hours per day (unpublished data). Even when present, the parents are often just 
bystanders.(2,3) Separating the child from the parents places the socio-emotional and cognitive development at 
risk.(4,5) Studies have shown that parental involvement during hospitalization facilitates growth, socio-
emotional, cognitive and linguistic development in preterm infants.(6-9) 
 
An intervention directed at empowering parents shortened the length of stay by 3.9 days in preterm infants.(10) 
Vohr et al. showed that in settings with single-family room architecture, the infants of actively participating 
mothers had on average 15 days shorter length of stay compared to infants of non-active mothers. Interventions 
aimed at family-centered care are heterogeneous and their effects vary. In a meta-analysis comprising seven 
studies on family-centered care interventions, the length of stay was unaffected, but on the other hand e.g. 
preterm subpopulations were not considered.(11)  
 
Parental presence can also be encouraged by hospital architecture. Even if modern hospitals nowadays include 
facilities also for parents based on the beneficial effects of single-family rooms (12,13), only 13.3% of 331 
neonatal units provided parents with the facilities needed to stay with their infant throughout a 24-hour day.(14) 
Single-family rooms shortened the length of stay by 10 days among very preterm infants born before 30 
gestational weeks in a randomized setting in Stockholm.(15) Also single-family room models are heterogeneous; 
according to a loose definition three solid walls suffices to qualify as single-family room, and does not necessarily 
include beds for the parents. A meta-analysis of 12 different single-family room studies did not show any 
significant benefit regarding length of stay compared to traditional hospital architecture.(16) However, in this 
meta-analysis most studies were observational studies without control groups; only one randomized study was 
included and no causal inferences could be drawn.  
 
The Close Collaboration with Parents training program has been developed in Turku University Hospital, Finland. 
It is a structured and comprehensive training program for neonatal staff aiming to support parenthood and 
parental involvement in neonatal intensive care. The program addresses staff attitudes by reflection and 
exercises. The program has been shown to improve implementation of family-centered care in the varying 
contexts of neonatal intensive care units in both regional hospitals and university hospitals. After the completion 
of the training program, parents spent more time with their child during hospitalization.(17) Nurses reported 
that the training program strengthened the family-centered care culture and that the program enforced the role 
of the parents as primary caregivers.(18,19) Breast feeding was commenced on average three weeks earlier than 
before the training program, skin-to-skin care was commenced earlier and the amount of skin-to-skin care 
increased. The weight gain of premature infants improved by 44.5%, and the mothers of very preterm infants 
suffered from fewer depressive symptoms.(20,21)  
 
It is imperative to study the economic impact of extensive, resource-demanding interventions that affect a whole 
neonatal unit. The Close Collaboration with Parents training program has so far been implemented in 11 neonatal 
units in Finland. In addition, four units have changed to single-family room architecture between 2014 and 2019. 
The national health care registers kept by the Institute for Health and Welfare contain a fully population-based 
dataset comprising all newborn infants (Medical Birth Register), hospitalizations and outpatient visits (Hospital 

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Discharge Register). These data are available since 1987, and enable retrospective research on the health and 
care of newborn infants. In Finland, we currently have a unique opportunity to study the effects of both a family-
centered care intervention and single-family room architecture in more controlled circumstances than in 
previous studies: the interventions have been performed systematically throughout the country; societal support 
such as paid parental leave and universal access to health care grant all parents the same opportunities to 
participate; the register data are comparable for all units; and preterm infants can be studied as a separate group.  
 
Research questions 
• 
Does the Close Collaboration with Parents training program affect the length of stay in neonatal units? 
• 
Does single-family room architecture affect the length of stay in neonatal units? 
• 
Do the interventions affect the need for outpatient visits after discharge during the first year of life? 
• 
Are the interventions cost-effective? 
• 
Do the interventions affect early postnatal growth in preterm infants? 
 
Our hypotheses are that the length of stay will be shorter, outpatient visits fewer and early postnatal growth 
better in units where either or both of these interventions have been implemented.  
 
Methods 
The study population will consist of all newborn infants born from January 1st 2006 to December 31st 2020, who 
have needed care in a neonatal unit immediately after birth. These infants will be identified from the Hospital 
Discharge Register. Data on vital background data, birth details, diagnoses, length of stay, growth parameters 
and outpatient visits will be obtained from the Hospital Discharge Register and the Medical Birth Register. These 
data will be linked through the infants’ personal identification codes, which will be replaced by a pseudonymized 
ID-number before delivering the data to the research group. Planned subgroup analyses will be done for preterm 
infants and for infants with significant congenital anomalies. 
 
Description of the interventions: Two interventions are studied (Figure 1) 
 
• 
Close Collaboration with Parents-training program in 11 neonatal units 
• 
Adoption of single-family room architecture in 4 neonatal units 
• 
Control group: Infants cared for in the 10 neonatal units where neither of the 
interventions have been implemented. 
 

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Outcomes: 
The primary outcome is the length of stay during the initial hospitalization to neonatal care. Comparisons will be 
made between infants cared for in intervention units and those cared for in non-intervention units.  
 
Secondary outcomes are: 
Corrected gestational age at discharge 
The amount of outpatient visits after discharge during the first year of life 
Growth parameters (weight, length, head circumference) at discharge compared to national standards 
Change in growth parameters from birth to discharge 
Cost effectiveness (according to hospitalization cost analyses carried out by the Institute for Health and Welfare) 
 
Statistical analysis: 
The planned analyses include a linear mixed model-approach to account for the effect of unit, degree of 
prematurity and intervention. Variables that will be considered for inclusion into the model are gestational age 
at birth, mode of delivery, birth weight z-score, plurality, neonatal morbidities, and receipt of antenatal steroids. 
 
Timeline 
During the year 2020 the research group has applied for funding, and research data permit from the Institute for 
Health and Welfare. Processing of the pseudonymized data will be initiated during the autumn of 2021. The 
analyses of the data and calculating of cost effectiveness will be done during 2021-2022. The manuscripts for 
scientific publishing will be drafted and submitted for publication during 2022-2023.  
 
 
Members of the research group and roles 
 
- 
Ryo Itoshima: Drafting of research plan, data application and analysis, drafting of research manuscripts 
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Suvi Lähteenmäki: Funding, drafting of research plan, data analysis and drafting of research 

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manuscripts, reporting of funding  
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Kjell Helenius: Drafting of research plan, data application and management, study supervision, editing 
of manuscripts  
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Anna Axelin: Funding, study supervision, editing of manuscripts 
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Sari Ahlqvist-Björkroth: Funding, study supervision, editing of manuscripts  
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Liisa Lehtonen: Principal investigator, funding, study supervision, editing of manuscripts 
 
Meaning and potential implications  
Costly interventions are done in neonatal care to enable parental involvement. The effects of these interventions 
are important for future resource allocation, so that investments can be planned based on scientific evidence. 
Also other fields of medicine nationally and internationally, both in pediatrics and adult medicine, could benefit 
from interventions that advance care practices and family centered care culture.  

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