A Father-friendly Neonatal Intensive Care Unit

August 30, 2022 updated by: Betty Nørgaard, Kolding Sygehus

What Effect Does a Father-friendly NICU Have on Children, Parents, and Staff?

An early parent-child relationship is important for a child's development, both intellectually and socially. The admission of premature or ill newborns to neonatal intensive care units (NICUs) may make the establishment of the parent-child relationship challenging due to parents' anxiety and despair.

Traditionally, most healthcare professionals have mainly focused on infants and mothers, even though fathers often feel stressed, powerless, and helpless, and find it difficult to establish a father-child relationship. The aim of this study is to investigate the effect of a father-friendly NICU on infants, parents and staff.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An early parent-child relationship is important for a child's development, both intellectually and socially. The admission of premature or ill newborns to neonatal intensive care units (NICUs) may make the establishment of the parent-child relationship challenging due to parents' anxiety and despair.

Traditionally, most healthcare professionals have mainly focused on infants and mothers, even though fathers often feel stressed, powerless, and helpless, and find it difficult to establish a father-child relationship. The aim of this study is to investigate the effect of a father-friendly NICU on infants, parents and staff.

The study was conducted in 3 steps

  1. A baseline measurement
  2. Development and implementation of the intervention a father friendly NICU
  3. After measurement

Different questionnaires were used:

  • The Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU)
  • The Nurse Parent Support Tool (NPST)
  • A questionnaire intended to measure nurses self-efficacy (SE).

The study was approved by the Danish Data Protection Agency (No 19/20297) and the procedures were in accordance with the Helsinki Declaration. In accordance with the Danish law, this study did not need to be reviewed by an ethics committee.

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Kolding, Denmark, 6000
        • Department of Paediatrics and Adolescent Medicine at the University Hospital of Southern Denmark, Kolding

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • fathers/mothers with infants admitted to the NICU were eligible
  • nurses who work in Danish NICUs

Exclusion Criteria:

  • fathers/mothers who did not understand verbal and written Danish
  • fathers/mothers of critically ill newborn infants
  • fathers of newborn infants whose mother was critically ill
  • fathers/mothers of newborn infants admitted to the NICU from home.
  • nurses without patient-contact, on maternity- or long-term sickness-leave

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Father-friendly NICU
  • Fathers have skin-to-skin contact with their infants
  • Fathers participate in important situations
  • Fathers receive information and guidance directly
  • Both parents participate in meaningful conversations
  • The department organize mother and father groups
  • The families have the opportunity to have a close family member to support them
  • Older siblings have the opportunity to stay overnight.
  • The department offer counseling by a social worker
Behavioral: The father-friendly NICU
  • Fathers have skin-to-skin contact with their infants
  • Fathers participate in important situations
  • Fathers receive information and guidance directly
  • Both parents participate in meaningful conversations
  • The department organize mother and father groups
  • The families have the opportunity to have a close family member to support them
  • Older siblings have the opportunity to stay overnight.
  • The department offer counseling by a social worker
No Intervention: No Father-friendly NICU (baseline)
Baseline - before implementation of the intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress (The Parental Stressor Scale: Neonatal Intensive Care Unit)
Time Frame: Measured on admission to the NICU (during the first 3 days of hospitalization), at the 14th day of hospitalization , and at the day of discharge from the NICU (up to 1/2 year)

The primary outcome was the difference in the overall stress score, determined using the Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) score in both the control and intervention groups.

Fathers were asked to rate their stress related to particular situations on a 5-point Likert scale, ranging from 1 (not at all stressful) to 5 (extremely stressful). Fathers who had not experienced a particular situation on an item indicated this with a "not relevant" response. The maximal score was 5, a high score indicating a high level of paternal stress.
Measured on admission to the NICU (during the first 3 days of hospitalization), at the 14th day of hospitalization , and at the day of discharge from the NICU (up to 1/2 year)
Parental Support (The Nurse Parent Support Tool)
Time Frame: Measured on admission to the NICU (during the first 3 days of hospitalization), and at the day of discharge from the NICU (up to 1/2 year)

The primary outcome was the difference in fathers' perception of received staff support in the control group compared to the intervention group.

The questionnaire included four dimensions of nurse support: 1) communication of information related to the infant's condition and care (nine items), 2) support mainly directed to enhance parental role (four items), 3) emotional support to help parents cope with their infant's sickness (three items), and 4) caregiving support concerning the quality of care provided to the infant (five items).

For each item, the parents indicated the degree of support on a 5-point Likert scale ranging from 1 (never) to 5 (always) 19.
Measured on admission to the NICU (during the first 3 days of hospitalization), and at the day of discharge from the NICU (up to 1/2 year)
Nurses self-efficacy (Self-efficacy (SE))
Time Frame: Before the start of the development of the intervention (August 2011) till 18 months after the implementation of the intervention (January 2015)

The primary outcome was the difference between the nurses' SE scores for father and mother questions in the intervention group in comparison with the control group

The nurses were asked to evaluate own ability to guide and support the parents in different situations (Self-efficacy score). The SE score was rated on a scale ranging from 1, indicating "Not at all sure," to 10, indicating "Definitely sure".
Before the start of the development of the intervention (August 2011) till 18 months after the implementation of the intervention (January 2015)
Self-efficacy follow-up
Time Frame: After the implementation of the intervention (January 2015) to five years after (February 2021).

The primary outcome was the difference between the nurses' SE score on father and mother questions from after the implementation of the intervention to five years after.

The nurses were asked to evaluate own ability to guide and support the parents in different situations (Self-efficacy score). The SE score was rated on a scale ranging from 1, indicating "Not at all sure," to 10, indicating "Definitely sure".
After the implementation of the intervention (January 2015) to five years after (February 2021).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kolding Sygehus

Investigators

  • Principal Investigator: Betty Noergaard, Ph.d, Department of Paediatrics and Adolescent Medicine, Lillebaelt Hospital,Kolding

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2011

Primary Completion (Actual)

January 31, 2015

Study Completion (Actual)

February 11, 2021

Study Registration Dates

First Submitted

August 24, 2022

First Submitted That Met QC Criteria

August 26, 2022

First Posted (Actual)

August 30, 2022

Study Record Updates

Last Update Posted (Actual)

August 31, 2022

Last Update Submitted That Met QC Criteria

August 30, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 19/20297

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all individual patient data (IPD) that underlie results in a publication

IPD Sharing Time Frame

Ending 5 years following article publication.

IPD Sharing Supporting Information Type

  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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