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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03693651

Acronym

SLEEP-PP

Enrollment

306

Registered

2018-10-03

Start date

2018-06-14

Completion date

2020-03-31

Last updated

2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parenting, Prematurity, Sleep Deprivation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Contacts

Primary ContactJacques SIZUN, Pr

jacques.sizun@chu-brest.fr02 98 22 36 67

Backup ContactJean-Michel ROUE, Dr

jean-michel.roue@chu-brest.fr02 98 22 36 67

Outcome results