Impact of Parent's Presence in Neonatology | NCT03344939

Studies
Impact of Parent's Presence in Neonatology

NCT03344939

Sponsor

Fondation Hôpital Saint-Joseph

Status

Completed

Last Update Posted

Feb 22, 2018Actual

Enrollment

38Actual

Phase

Not provided

Conditions

Newborn; Vitality

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2016Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Nov 13, 2017

First Submission Date that Met QC Criteria

Nov 15, 2017

First Posted Date

Nov 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2018

Last Update Posted Date

Feb 22, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of hours spent with the newborn baby the night.		Day 5

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

every newborn baby hospitalized in neonatology yard

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

7 Days

Standard Ages

Child

Study Population

every newborn baby hospitalized in neonatology yard

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Paris Saint Joseph		Paris	Île-de-France Region	75014	France