Postnatal CareUKLANCT06243861
Attachment Bonding and Neonatal Hospitalization: the Impact of Hospitalization in a Kangaroo Unit
An observational study of Postnatal Care, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postnatal Care
- What is being tested?
- Mother-child bond
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2024to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patient hospitalized in a Kangaroo Unit or in a post-natal unit
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Postnatal Care
- Being tested
- Mother-child bond
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother-child bondBehavioural
assessing whether the mother-child bond is degraded in the UK, in comparison with that of mothers in post-natal care
| Study group | Role | What they receive |
|---|---|---|
| kangaroo unit | Not described Receives: Behavioral: Mother-child bond | |
| postnatal care | Not described Receives: Behavioral: Mother-child bond |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother-infant bonding
Mother-infant bonding score from Taylor's Mother to Infant Bonding Scale (MIBS)
Measured: Up to 3 days after delivery
Secondary outcomes (3)
Assessment of mothers' state and trait anxiety levels
using Spielberger's STAY form Y1 and Y2: a self-reported questionnaire with 20 items assessed on a 4 points scale
Measured: Up to 3 days after delivery
Assessment of perceived parenting competence
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".
Measured: Up to 3 days after delivery
Assessment of patients' quality of life
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).
Measured: Up to 3 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start10 Apr 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Why it stopped: Abandoned research due to the low participation rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Laure BOYE, Principal investigator, CHR Metz Thionville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243861
- Sponsor's protocol ID
- 2023-08Obs-CHRMT
- Acronym
- UKLA
- Status last verified
- Jun 2026
- First submitted
- 29 Jan 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attachment Bonding and Neonatal Hospitalization: the Impact of Hospitalization in a Kangaroo Unit
- ClinicalTrials.gov ID
- NCT06243861
- Acronym / sponsor ID
- UKLA / 2023-08Obs-CHRMT
- Conditions
- Postnatal Care
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Abandoned research due to the low participation rate
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| kangaroo unit | – | Behavioral: Mother-child bond |
| postnatal care | – | Behavioral: Mother-child bond |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient hospitalized in a Kangaroo Unit or in a post-natal unit
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Patient who :
- Patient under court protection, guardianship or curatorship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mother-child bondassessing whether the mother-child bond is degraded in the UK, in comparison with that of mothers in post-natal care | Behavioural | kangaroo unit, postnatal care |
Primary outcome
Mother-infant bonding
Time frame: Up to 3 days after delivery
Mother-infant bonding score from Taylor's Mother to Infant Bonding Scale (MIBS)
3 secondary outcomes
Assessment of mothers' state and trait anxiety levels
Time frame: Up to 3 days after delivery
Assessment of perceived parenting competence
Time frame: Up to 3 days after delivery
Assessment of patients' quality of life
Time frame: Up to 3 days after delivery
Results and safety
The study was stopped early (reason given: Abandoned research due to the low participation rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Laure BOYE principal investigator
CHR Metz Thionville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postnatal Care, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Abandoned research due to the low participation rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother-infant bonding (time frame: Up to 3 days after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.