Attachment Bonding and Neonatal Hospitalization: the Impact of Hospitalization in a Kangaroo Unit (UKLA)

The Kangaroo Unit (UK) takes care of newborns requiring special care or monitoring for a pathology whose clinical situation is stable and whose prognosis is favorable. In order to avoid separating mother and child, these units were created with a care pathway somewhere between that requiring hospitalization in a neonatal unit and that of pathology-free newborns in post-natal care. Theoretically, the mother-child bond created in the UK is as good as that created in conventional post-natal care. However, studies show that there are limits to the quality of the bond in the UK. This study aims to assess whether the mother-child bond is degraded in the UK, in comparison with that of mothers in post-natal care.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

34

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

      • Metz, France, 57085
        • CHR Metz-Thionville/Hopital Mercy

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patient hospitalized in a Kangaroo Unit or in a post-natal unit

Description

Inclusion Criteria:

  • Patient over 18 years of age, hospitalized in a Kangaroo Unit or in a post-natal unit,
  • Affiliated to a social security scheme,
  • fluent in French
  • no objection of participation

Exclusion Criteria:

  • Patient who :

    • given birth to a child who was stillborn or died at birth
    • difficulty understanding written French
    • psychological incapacity (psychiatric disorder, too great a vulnerability) or physical incapacity (physical/motor disability) to answer questionnaires,
  • Patient under court protection, guardianship or curatorship.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
kangaroo unit
assessing whether the mother-child bond is degraded in the UK, in comparison with that of mothers in post-natal care
postnatal care
assessing whether the mother-child bond is degraded in the UK, in comparison with that of mothers in post-natal care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mother-infant bonding
Time Frame: Up to 3 days after delivery
Mother-infant bonding score from Taylor's Mother to Infant Bonding Scale (MIBS)
Up to 3 days after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of mothers' state and trait anxiety levels
Time Frame: Up to 3 days after delivery
using Spielberger's STAY form Y1 and Y2: a self-reported questionnaire with 20 items assessed on a 4 points scale
Up to 3 days after delivery
Assessment of perceived parenting competence
Time Frame: Up to 3 days after delivery
using Gibaud-Wallston's Parenting Sense of Competence Scale (PSOC). The PSOC is a 17 item scale, with 2 subscales. Each item is rated on a 6 point Likert scale anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree".
Up to 3 days after delivery
Assessment of patients' quality of life
Time Frame: Up to 3 days after delivery
using the McGill Quality of Life Questionnaire (MQOL). consists of 14 items divided into four domains: The Single-Item Scale (SIS), physical symptoms (three items), feelings and thoughts (seven items), and social (three items).
Up to 3 days after delivery

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Marie-Laure BOYE, CHR Metz Thionville

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)

April 10, 2024

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 20, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2023-08Obs-CHRMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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