NCT03394443

Brief Summary

This study aims to understand parents' needs regarding social difficulties faced in a child's preterm birth context.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 28, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

December 28, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

2 months

First QC Date

December 28, 2017

Last Update Submit

January 8, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Social, environmental and economic difficulties encountered by parents

    Qualitative analysis of semi-structured interviews

    Month 1

Interventions

Semi-structured interviews of the parents of preterm infants. 3 weeks after their child has left hospital. They will be made either at the University Hospital of Besançon. They will take place in a dedicated hospital ward to ensure the confidentiality of the statements made between the investigator and the parent. They will follow a predefined questionnaire. They will be fully recorded on a dictaphone with note taking during the interview by the investigator and will be transcribed in writing anonymously and confidentially on Word. The content of the interviews will be analyzed: * As a first step, it will be a vertical analysis of the thematization of each interview * Then, in a second step, a transversal analysis between the contents of the different interviews.

Eligibility Criteria

AgeUp to 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Parents of a premature new-born baby (\< 37 SA)

You may qualify if:

  • Parents (father or mother ) of a premature new-born baby (\< 37 SA) hospitalised in Besancon University Hospital at birth.

You may not qualify if:

  • Parents \< 18 years old
  • Refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, France

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

December 28, 2017

First Posted

January 9, 2018

Study Start

December 28, 2017

Primary Completion

March 1, 2018

Study Completion

April 1, 2018

Last Updated

January 9, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations