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

• Conditions: Parenting; Prematurity; Sleep Deprivation

• Registration Number: NCT03693651
• Lead Sponsor: University Hospital, Brest

Brief Summary

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

Not available

Study Timeline

• Study Start: 2018-06-14
• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-03
• Status Verified: 2020-01
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17
• Primary Completion: 2020-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 306

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scale Pittsburgh Sleep Quality Index (PSQI)	6 months from child Birth	Online self-report questionnaire that assesses sleep quality filled at 1 month, 3 months and 6 months from child birth.; This questionnaire has been validated to assess the presence of sleep disorders.; It includes 19 questions that combine to evaluate 7 components of sleep, each evaluated from 0 to 3 (0 = no difficulty, 3 = severe difficulty).; A total score greater than 5 indicates a sleep disorder.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHRU Brest; 🇫🇷 Brest, France