NCT06243861

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

January 29, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 10, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2025

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

January 29, 2024

Last Update Submit

May 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mother-infant bonding

    Mother-infant bonding score from Taylor's Mother to Infant Bonding Scale (MIBS)

    Up to 3 days after delivery

Secondary Outcomes (3)

  • Assessment of mothers' state and trait anxiety levels

    Up to 3 days after delivery

  • Assessment of perceived parenting competence

    Up to 3 days after delivery

  • Assessment of patients' quality of life

    Up to 3 days after delivery

Study Arms (2)

kangaroo unit

Behavioral: Mother-child bond

postnatal care

Behavioral: Mother-child bond

Interventions

assessing whether the mother-child bond is degraded in the UK, in comparison with that of mothers in post-natal care

kangaroo unitpostnatal care

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsstudy conducted in mothers
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Metz-Thionville/Hopital Mercy

Metz, 57085, France

RECRUITING

Study Officials

  • Marie-Laure BOYE

    CHR Metz Thionville

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 6, 2024

Study Start

April 10, 2024

Primary Completion

April 10, 2025

Study Completion

April 10, 2025

Last Updated

May 17, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations