NCT03344939

Brief Summary

Every year 75000 new-born babies are hospitalized in neonatology yard in France with about 60000 born prematurely. Studies showed that parents presence is good for the baby development , decrease the stress due to hospitalization.It's also efficient for the attachment between the baby and parents. Although the team try to settle a good atmosphere to establish this link and let parents take their position,it seems that the time taken to stay with the baby is less moreover the night. The aim of the study is to evaluate the time of presence to find tools to increase this time in the neonatotology yard

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 22, 2018

Status Verified

November 1, 2017

Enrollment Period

12 months

First QC Date

November 13, 2017

Last Update Submit

February 20, 2018

Conditions

Newborn; Vitality

Outcome Measures

Primary Outcomes (1)

  • number of hours spent with the newborn baby the night.

    Day 5

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

every newborn baby hospitalized in neonatology yard

You may qualify if:

  • every newborn baby hospitalized in neonatology yard

You may not qualify if:

  • no french speaking parents
  • duration of hospitalization less than 1 week.

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 Design

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

Study Record Dates

First Submitted

November 13, 2017

First Posted

November 17, 2017

Study Start

December 5, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 22, 2018

Record last verified: 2017-11

Locations

FR(1)