NCT03046602

Brief Summary

The transfer of newborn child from Intensive Care Unit to maternity is very stressfull for parents.This anxiety could have repercussion on parents adaptation on their new environment, on parent's role and also on their relaional interaction with the baby. As StJoseph hospital receives an important number of premature babies, the neonatology service aim to evaluate the real life experience of mothers during the transfer to set up improvement axes with hospital departments upstream.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

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

March 7, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

10 months

First QC Date

February 5, 2017

Last Update Submit

August 8, 2018

Conditions

Neonatology

Outcome Measures

Primary Outcomes (1)

  • mother's real life experience assessment during the transfer of new born child from intensive care unit to neonatology

    day 3 to 5

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Every new born child transfered to St Joseph neonatology service

You may qualify if:

  • new born child transfered to St Joseph neonatology service
  • Having stayed at least five days Intensive Care Unit
  • Regardless of the term
  • have to stay at least five days in neonatology

You may not qualify if:

  • Non francophones parents
  • Duration of predictable hospitalization of less than 5 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

  • Hélène BEAUSSIER, Pharm-D

    CRC- GHPSJ

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 5, 2017

First Posted

February 8, 2017

Study Start

March 7, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

August 10, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)