Prospective Study of the Quality of Sleep of Parents of Premature Children Hospitalized in Neonatology Compared to Parents of Full-term Children in Maternity

University Hospital, Brest1 site in 1 country306 target enrollmentJune 14, 2018

ConditionsPrematurity Parenting Sleep Deprivation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prematurity
Sponsor: University Hospital, Brest
Enrollment: 306
Locations: 1
Primary Endpoint: Scale Pittsburgh Sleep Quality Index (PSQI)
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 14, 2018

End Date

March 2020

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University Hospital, Brest

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Scale Pittsburgh Sleep Quality Index (PSQI)

Time Frame: 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.