- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06243861
Attachment Bonding and Neonatal Hospitalization: the Impact of Hospitalization in a Kangaroo Unit (UKLA)
June 20, 2026 updated by: Centre Hospitalier Régional Metz-Thionville
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
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
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-
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.