Study of the Quality of Sleep of Parents of Premature Children Compared to Parents of Full-term Children

NCT ID: NCT03693651

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

306 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-14

Study Completion Date

2020-03-31

Brief Summary

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This study evaluate the incidence of sleep disorders in parents of premature children hospitalized in unit care of neonatalogy or intensive unit care of neonatalogy, compared to parents of full-term child in maternity.

Detailed Description

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Conditions

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Prematurity Parenting Sleep Deprivation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Parent of a Premature infant / PP

self-report questionnaire that assesses sleep quality (The Pittsburgh Sleep Quality Index (PSQI)) filled at 1 month, 3 months and 6 months from child birth.

No interventions assigned to this group

Parent of a baby born on time / PT

self-report questionnaire that assesses sleep quality (The Pittsburgh Sleep Quality Index (PSQI)) filled at 1 month, 3 months and 6 months from child birth.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Couple of parents of children born before term (between 25 and 36 weeks) and hospitalized at the CHRU de Brest.
* Parents of healthy full-term children born at Brest CHRU (\> 37 weeks) without neonatal hospitalization.
* Having formulated their agreement

Exclusion Criteria

* Parents whose child died in the neonatal period.
* Couple whose one parents are minors at the birth of the child.
* Parents of children with malformation and /or genetic anomaly.
* Parents with known addiction, depressive syndrome or known psychiatric condition before birth.
* Single parent family.
* Non-French speaking parents.
* Refusal of participation of one of the parents.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU Brest

Brest, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jacques SIZUN, Pr

Role: CONTACT

02 98 22 36 67

Jean-Michel ROUE, Dr

Role: CONTACT

02 98 22 36 67

Facility Contacts

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Jacques SIZUN

Role: primary

02 98 22 36 67

Jean-Michel ROUE

Role: backup

02 98 22 36 67

Other Identifiers

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SLEEP-PP (29BRC18.0079)

Identifier Type: -

Identifier Source: org_study_id

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