PrematuritySLEEP-PPNCT03693651
Study of the Quality of Sleep of Parents of Premature Children Compared to Parents of Full-term Children
An observational study of Prematurity and Parenting, run by University Hospital, Brest at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prematurity, Parenting, Sleep Deprivation
- How many people
- 306 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2018to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Couple of Parents of child born at the CHRU of Brest (full-term in maternity or premature child (25-36 weeks) hospitalized in maternity, neonatalogy or unity of intensive neonatal care). Both Parents will be included, each of them will have to fill the PSQI at 1, 3 and 6 months from the child birth.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU Brest
Brest, 29200
Jacques SIZUN, 02 98 22 36 67, jacques.sizun@chu-brest.fr
Jean-Michel ROUE, 02 98 22 36 67, jean-michel.roue@chu-brest.fr
About this study
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
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.
- Conditions
- Prematurity, Parenting, Sleep Deprivation
- Medical subject headings
- Premature Birth, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parent of a Premature infant / PP | self-report questionnaire that assesses sleep quality (The Pittsburgh Sleep Quality Index (PSQI)) filled at 1 month, 3 months and 6 months from child birth. | |
| Parent of a baby born on time / PT | self-report questionnaire that assesses sleep quality (The Pittsburgh Sleep Quality Index (PSQI)) filled at 1 month, 3 months and 6 months from child birth. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months from child Birth
Secondary outcomes (2)
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.
Measured: 1 month from child birth
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.
Measured: 3 months from child birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start14 Jun 2018
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693651
- Sponsor's protocol ID
- SLEEP-PP (29BRC18.0079)
- Acronym
- SLEEP-PP
- Status last verified
- Jan 2020
- First submitted
- 23 Aug 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03693651
- Acronym / sponsor ID
- SLEEP-PP / SLEEP-PP (29BRC18.0079)
- Conditions
- Prematurity, Parenting, Sleep Deprivation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent of a Premature infant / PP | – | –self-report questionnaire that assesses sleep quality (The Pittsburgh Sleep Quality Index (PSQI)) filled at 1 month, 3 months and 6 months from child birth. |
| Parent of a baby born on time / PT | – | –self-report questionnaire that assesses sleep quality (The Pittsburgh Sleep Quality Index (PSQI)) filled at 1 month, 3 months and 6 months from child birth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Couple of Parents of child born at the CHRU of Brest (full-term in maternity or premature child (25-36 weeks) hospitalized in maternity, neonatalogy or unity of intensive neonatal care). Both Parents will be included, each of them will have to fill the PSQI at 1, 3 and 6 months from the child birth.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: 1 month from child birth
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: 3 months from child birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: No
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity and Parenting, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacques SIZUN, Pr (02 98 22 36 67, jacques.sizun@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale Pittsburgh Sleep Quality Index (PSQI) (time frame: 6 months from child Birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.