NCT05521620

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

December 1, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2015

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

3.2 years

First QC Date

August 24, 2022

Last Update Submit

August 30, 2022

Conditions

Keywords

FatherIntensive Care Units, NeonatalParental supportStressSelf-efficacyMothersNurseParticipatory reseachMasculinity

Outcome Measures

Primary Outcomes (4)

  • Stress (The Parental Stressor Scale: Neonatal Intensive Care Unit)

    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)

    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))

    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

    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).

Study Arms (2)

Father-friendly NICU

ACTIVE COMPARATOR

* 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

No Father-friendly NICU (baseline)

NO INTERVENTION

Baseline - before implementation of the intervention

Interventions

* 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

Father-friendly NICU

Eligibility Criteria

Sexall(Gender-based eligibility)
Gender Eligibility Detailsmother and father
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kolding, 6000, Denmark

Location

Related Publications (23)

  • Meberg A, Wataker H. [Family-focused neonatal care]. Tidsskr Nor Laegeforen. 2010 Sep 9;130(17):1730-1. doi: 10.4045/tidsskr.10.0293. No abstract available. Norwegian.

    PMID: 20835285BACKGROUND
  • Fegran L, Helseth S, Fagermoen MS. A comparison of mothers' and fathers' experiences of the attachment process in a neonatal intensive care unit. J Clin Nurs. 2008 Mar;17(6):810-6. doi: 10.1111/j.1365-2702.2007.02125.x.

    PMID: 18279284BACKGROUND
  • Lindberg B, Axelsson K, Ohrling K. Adjusting to being a father to an infant born prematurely: experiences from Swedish fathers. Scand J Caring Sci. 2008 Mar;22(1):79-85. doi: 10.1111/j.1471-6712.2007.00563.x.

    PMID: 18269426BACKGROUND
  • Sullivan JR. Development of father-infant attachment in fathers of preterm infants. Neonatal Netw. 1999 Oct;18(7):33-9. doi: 10.1891/0730-0832.18.7.33.

    PMID: 10808886BACKGROUND
  • Mackley AB, Locke RG, Spear ML, Joseph R. Forgotten parent: NICU paternal emotional response. Adv Neonatal Care. 2010 Aug;10(4):200-3. doi: 10.1097/ANC.0b013e3181e946f0.

    PMID: 20697219BACKGROUND
  • Pohlman S. Fathering premature infants and the technological imperative of the neonatal intensive care unit: an interpretive inquiry. ANS Adv Nurs Sci. 2009 Jul-Sep;32(3):E1-16. doi: 10.1097/ANS.0b013e3181b0d68c.

    PMID: 19707083BACKGROUND
  • Lundqvist P, Westas LH, Hallstrom I. From distance toward proximity: fathers lived experience of caring for their preterm infants. J Pediatr Nurs. 2007 Dec;22(6):490-7. doi: 10.1016/j.pedn.2007.04.008.

    PMID: 18036470BACKGROUND
  • Kaaresen PI, Ronning JA, Ulvund SE, Dahl LB. A randomized, controlled trial of the effectiveness of an early-intervention program in reducing parenting stress after preterm birth. Pediatrics. 2006 Jul;118(1):e9-19. doi: 10.1542/peds.2005-1491.

    PMID: 16818541BACKGROUND
  • Pohlman S. The primacy of work and fathering preterm infants: findings from an interpretive phenomenological study. Adv Neonatal Care. 2005 Aug;5(4):204-16. doi: 10.1016/j.adnc.2005.03.002.

    PMID: 16084478BACKGROUND
  • Franck LS, Spencer C. Parent visiting and participation in infant caregiving activities in a neonatal unit. Birth. 2003 Mar;30(1):31-5. doi: 10.1046/j.1523-536x.2003.00214.x.

    PMID: 12581037BACKGROUND
  • Lundqvist P, Jakobsson L. Swedish men's experiences of becoming fathers to their preterm infants. Neonatal Netw. 2003 Nov-Dec;22(6):25-31. doi: 10.1891/0730-0832.22.6.25.

    PMID: 14700179BACKGROUND
  • Miles MS, Holditch-Davis D. Parenting the prematurely born child: pathways of influence. Semin Perinatol. 1997 Jun;21(3):254-66. doi: 10.1016/s0146-0005(97)80067-5.

    PMID: 9205979BACKGROUND
  • Ortenstrand A, Westrup B, Brostrom EB, Sarman I, Akerstrom S, Brune T, Lindberg L, Waldenstrom U. The Stockholm Neonatal Family Centered Care Study: effects on length of stay and infant morbidity. Pediatrics. 2010 Feb;125(2):e278-85. doi: 10.1542/peds.2009-1511. Epub 2010 Jan 25.

    PMID: 20100748BACKGROUND
  • Johnson AN. Engaging fathers in the NICU: taking down the barriers to the baby. J Perinat Neonatal Nurs. 2008 Oct-Dec;22(4):302-6. doi: 10.1097/01.JPN.0000341361.37822.34.

    PMID: 19011495BACKGROUND
  • Arockiasamy V, Holsti L, Albersheim S. Fathers' experiences in the neonatal intensive care unit: a search for control. Pediatrics. 2008 Feb;121(2):e215-22. doi: 10.1542/peds.2007-1005. Epub 2008 Jan 8.

    PMID: 18182470BACKGROUND
  • Novak JC. Facilitating nurturant fathering behavior in the NICU. J Perinat Neonatal Nurs. 1990 Sep;4(2):68-77. doi: 10.1097/00005237-199009000-00009.

    PMID: 2391649BACKGROUND
  • Levy-Shiff R, Hoffman MA, Mogilner S, Levinger S, Mogilner MB. Fathers' hospital visits to their preterm infants as a predictor of father-infant relationship and infant development. Pediatrics. 1990 Aug;86(2):289-93.

    PMID: 2371105BACKGROUND
  • Bogdan R, Brown MA, Foster SB. Be honest but not cruel: staff/parent communication on a neonatal unit. Hum Organ. 1982 Spring;41(1):6-16. doi: 10.17730/humo.41.1.03x7x4214201v7p2. No abstract available.

    PMID: 10254504BACKGROUND
  • Ammentorp J, Kofoed PE. Coach training can improve the self-efficacy of neonatal nurses. A pilot study. Patient Educ Couns. 2010 May;79(2):258-61. doi: 10.1016/j.pec.2009.08.015. Epub 2009 Sep 27.

    PMID: 19786336BACKGROUND
  • Reid M, Lloyd D, Campbell G, Murray K, Porter M. Scottish neonatal intensive care units; a study of staff and parental attitudes. Health Bull (Edinb). 1995 Sep;53(5):314-25.

    PMID: 7490204BACKGROUND
  • Noergaard B, Ammentorp J, Garne E, Fenger-Gron J, Kofoed PE. Fathers' Stress in a Neonatal Intensive Care Unit. Adv Neonatal Care. 2018 Oct;18(5):413-422. doi: 10.1097/ANC.0000000000000503.

  • Noergaard B, Ammentorp J, Fenger-Gron J, Kofoed PE, Johannessen H, Thibeau S. Fathers' Needs and Masculinity Dilemmas in a Neonatal Intensive Care Unit in Denmark. Adv Neonatal Care. 2017 Aug;17(4):E13-E22. doi: 10.1097/ANC.0000000000000395.

  • Noergaard B, Johannessen H, Fenger-Gron J, Kofoed PE, Ammentorp J. Participatory Action Research in the Field of Neonatal Intensive Care: Developing an Intervention to Meet the Fathers' Needs. A Case Study. J Public Health Res. 2016 Dec 21;5(3):744. doi: 10.4081/jphr.2016.744. eCollection 2016 Dec 9.

MeSH Terms

Conditions

Masculinity

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Betty Noergaard, Ph.d

    Department of Paediatrics and Adolescent Medicine, Lillebaelt Hospital,Kolding

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: A before- and-after intervention study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 24, 2022

First Posted

August 30, 2022

Study Start

December 1, 2011

Primary Completion

January 31, 2015

Study Completion

February 11, 2021

Last Updated

August 31, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
SAP
Time Frame
Ending 5 years following article publication.

Locations