Study of the Quality of Sleep of Parents of Premature Children Compared to Parents of Full-term Children
Sponsor:
University Hospital, Brest
Collaborators:
Information provided by (Responsible Party):
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| Tracking Information | |||
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| First Submitted Date ICMJE | August 23, 2018 | ||
| First Posted Date ICMJE | October 3, 2018 | ||
| Last Update Posted Date | October 3, 2018 | ||
| Actual Study Start Date ICMJE | June 14, 2018 | ||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Study of the Quality of Sleep of Parents of Premature Children Compared to Parents of Full-term Children |
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| Official Title ICMJE | Prospective Study of the Quality of Sleep of Parents of Premature Children Hospitalized in Neonatology Compared to Parents of Full-term Children in Maternity |
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| 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. |
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| Detailed Description | |||
| Study Type ICMJE | Observational | ||
| Study Phase | |||
| Study Design ICMJE | Allocation: Intervention Model: Intervention Model Description: Masking: Observational Masking Description: Primary Purpose: |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Recruiting | ||
| Estimated Enrollment ICMJE |
276 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | December 2019 | ||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | 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. | ||
| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | France | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | ， | ||
| Study Sponsor ICMJE | University Hospital, Brest | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | |||
| Verification Date | June 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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