NCT04635150

Brief Summary

The aim of this study was to evaluate the effects of an educational intervention for neonatal staff on parent-infant physical closeness during their infant's stay in the Neonatal Intensive Care Unit (NICU) and parents' and staff perception on family centered care in the unit. This pre-post intervention study was carried out in nine hospitals in Finland in 2012 through 2018. Data was collected by using daily parental diaries, daily text message questions to parents and an audit interview for the staff.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
768

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2012

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

6.3 years

First QC Date

November 12, 2020

Last Update Submit

November 17, 2020

Conditions

Keywords

NICUFamily centered careParent-infant closenessSkin-to-skin

Outcome Measures

Primary Outcomes (4)

  • Parental Closeness Diary of parents' presence

    Daily Closeness Diary including space for both mothers and fathers to indicate their presence in the neonatal unit (minutes/per day in 5-minute accuracy) to be filled in during all hospital days of the infant (up to 3 months).

    During the time the infant was cared for in the neonatal unit (up to 3 months), applicable to both cohorts of infants: those recruited before and after the intervention.

  • Parental Closeness Diary of parent-infant skin-to-skin contact

    Daily Closeness Diary including space for both mothers and fathers to indicate skin-to-skin contact with their infant (minutes/per day in 5-minute accuracy) to be filled in during all hospital days of the infant (up to 3 months). Skin-to-skin contact is defined as the infant is lying naked on a parent's chest.

    During the time the infant was cared for in the neonatal unit (up to 3 months), applicable to both cohorts of infants: those recruited before and after the intervention. .

  • Daily text message questions to both mothers and fathers/partners about parents' satisfaction to family centered care

    Both parents received one question (randomly out of 9 questions) every evening at 9 pm to report their satisfaction about the specific issue during that day.

    During the time the infant was cared for in the neonatal unit (up to 3 months), applicable to both cohorts of infants: those recruited before and after the intervention.

  • Web questions for the staff about the quality of family centered care they have provided during their work shift

    Each staff member responded to one web question (randomly out of 8 questions) after each workshift about the quality of family centered care they had provided that day.

    Three months before and three months after the intervention.

Study Arms (1)

Post-intervention parents and staff

EXPERIMENTAL

An educational intervention for the multidisciplinary staff of a neonatal intensive care unit.

Behavioral: Close Collaboration with Parents

Interventions

Close Collaboration with Parents Training Program is an educational intervention for multidisciplinary NICU staff initially developed and implemented at Turku University Hospital to promote FCC. The intervention consists of four phases lasting 4 to 5 months each. First the healthcare staff learn to observe infant behavior. This phase aims at identifying the individual needs and features of each infant. After that, the staff observe infant behavior with the parents and learn to actively listen to parents' perceptions about their infant. During the phase III, staff learn to know the individual story of the family and their infant, which supports partnership between staff and parents. Finally, staff learn to integrate parents in decision-making and collaboratively plan the transition to home. The training is delivered through facilitator-network model in which local mentors are trained by the trainer mentors and supervisors.

Post-intervention parents and staff

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Every parent of an infant estimated to stay in the NICU longer than three days was approached.

You may not qualify if:

  • Infant had major congenital anomalies or syndromes,
  • Parents spoke neither Finnish or Swedish,
  • Family lived outside the catchment area of the hospital.
  • All staff members working at bedside and leadership.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • He FB, Axelin A, Ahlqvist-Bjorkroth S, Raiskila S, Loyttyniemi E, Lehtonen L. Effectiveness of the Close Collaboration with Parents intervention on parent-infant closeness in NICU. BMC Pediatr. 2021 Jan 11;21(1):28. doi: 10.1186/s12887-020-02474-2.

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Pre-post intervention study with different cohorts before and after the intervention.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 18, 2020

Study Start

May 30, 2012

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

November 18, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share