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

Parenting Clinical Trial

— SLEEP-PP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03693651
• Other study ID #: SLEEP-PP (29BRC18.0079)
• Status: Recruiting
• Start date: June 14, 2018
• Est. completion date: March 2020

Study information

• Verified date: January 2020
• Source: University Hospital, Brest
• Contact: Jacques SIZUN, Pr
• Phone: 02 98 22 36 67
• Email: jacques.sizun[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 306
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parenting
• Prematurity
• Sleep Deprivation

Locations

Country	Name	City	State
France	CHRU Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

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