Preterm InfantsNCT03438071
Impact of Videoconference Updates in Neonatal Intensive Care Unit on Parental Stress of Preterm Infants (VISIO-NEONAT)
An observational study of Preterm Infants and Parent-Child Relations, run by Poitiers University Hospital at 1 site in France.
Trial summary
The aim of the study is to test the effect of daily videoconference updates between parents of preterm newborns and health care providers which also offer them the possibility of seeing their child on the parental stress in a neonatal intensive care unit (NICU). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preterm Infants, Parent-Child Relations, Parental Stress
- What is being tested?
- Videoconferencing
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2018to 7 Sep 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 30 preterm infants and their parents (15 in each group)
Who may be able to join
- Parents with a preterm child born between 24 weeks and 34 weeks and 6 days of gestational age, hospitalized in our NICU during recrutment period
- Which agreed participating to the study after having complete information about it and sign a consent.
Who cannot join
- Parents with a preterm child with another pathology than prematurity or with a lenght of stay in the NICU less than 7 days
- Parents refusing to participate to the study
- Parents not having videoconference equipment or internet access at home
- Parents not understanding or speaking good enough French.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Daily Videoconference Updates in Neonatal Intensive Care Unit on Parental Stress of Preterm Infants : a Pilot Study
The aim of the study is to test the effect of daily videoconference updates between parents of preterm newborns and health care providers which also offer them the possibility of seeing their child on the parental stress in a neonatal intensive care unit (NICU).
- Conditions
- Preterm Infants, Parent-Child Relations, Parental Stress, Post Partum Depression, Neonatal Intensive Care Units, Videoconferencing
- Being tested
- Videoconferencing
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoconferencingOther
Daily videoconference updates using Skype between parents of preterm infants hospitalized in NICU and the nurse taking care of their child, lasting 5 to 10 minutes, to check with her for the daily news and then see their child through the camera.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Not described | |
| Videoconference group | Not described Receives: Other: Videoconferencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of stress of the mothers
Mean score of the mothers of preterm infants hospitalized in NICU on the PSS-NICU (Parental Stressor Scale NICU), measured once a week during all the last of their child's hospitalization in the unit, in the 2 groups.
Measured: From date of inclusion until the date of discharge, assessed up to 1 month
Secondary outcomes (4)
Level of stress of the fathers
Mean score of the fathers of preterm infants hospitalized in NICU on the PSS-NICU, measured once a week during all the last of their child's hospitalization in the unit, in the 2 groups.
Measured: From date of inclusion until the date of discharge, assessed up to 1 month
Parental stress evolution
Evolution of the PSS-NICU score of both parents between the inclusion in the study and the last evaluation before their child's discharge of the NICU, in the 2 groups.
Measured: From the date of inclusion until the date of discharge, assessed up to 1 month
Post-partum depression rate of the mothers
Score of the mothers of preterm infants hospitalized in NICU on the EPDS (Edinburgh Post-natal Depression Scale), measured at the inclusion, at discharge and a month later, in the 2 groups.
Measured: Through study completion, an average of 2 months
Quality of the relationship between the parents and their child
Mean score of both parents of preterm infants hospitalized in NICU on the PBQ (Post-partum Bonding Questionnaire), measured once a week during all the last of their child's hospitalization in the unit and a month after his discharge, in the 2 groups.
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start21 Feb 2018
- Primary completion18 Aug 2018
- Study completion7 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Oriot, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438071
- Sponsor's protocol ID
- VISIO-NEONAT
- Status last verified
- May 2020
- First submitted
- 4 Feb 2018
- Last updated
- 1 Jun 2020
- Results posted
- 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 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Daily Videoconference Updates in Neonatal Intensive Care Unit on Parental Stress of Preterm Infants : a Pilot Study
- ClinicalTrials.gov ID
- NCT03438071
- Acronym / sponsor ID
- VISIO-NEONAT
- Conditions
- Preterm Infants, Parent-Child Relations, Parental Stress, Post Partum Depression, Neonatal Intensive Care Units, Videoconferencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 18 Aug 2018 (actual)
- Study completion
- 7 Sep 2018 (actual)
- First posted
- 19 Feb 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.
The aim of the study is to test the effect of daily videoconference updates between parents of preterm newborns and health care providers which also offer them the possibility of seeing their child on the parental stress in a neonatal intensive care unit (NICU).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | – |
| Videoconference group | – | Other: Videoconferencing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 30 preterm infants and their parents (15 in each group)
Key inclusion criteria (2 listed)
- Parents with a preterm child born between 24 weeks and 34 weeks and 6 days of gestational age, hospitalized in our NICU during recrutment period
- Which agreed participating to the study after having complete information about it and sign a consent.
Key exclusion criteria (4 listed)
- Parents with a preterm child with another pathology than prematurity or with a lenght of stay in the NICU less than 7 days
- Parents refusing to participate to the study
- Parents not having videoconference equipment or internet access at home
- Parents not understanding or speaking good enough French.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideoconferencingDaily videoconference updates using Skype between parents of preterm infants hospitalized in NICU and the nurse taking care of their child, lasting 5 to 10 minutes, to check with her for the daily news and then see their child through the camera. | Other | Videoconference group |
Primary outcome
Level of stress of the mothers
Time frame: From date of inclusion until the date of discharge, assessed up to 1 month
Mean score of the mothers of preterm infants hospitalized in NICU on the PSS-NICU (Parental Stressor Scale NICU), measured once a week during all the last of their child's hospitalization in the unit, in the 2 groups.
4 secondary outcomes
Level of stress of the fathers
Time frame: From date of inclusion until the date of discharge, assessed up to 1 month
Parental stress evolution
Time frame: From the date of inclusion until the date of discharge, assessed up to 1 month
Post-partum depression rate of the mothers
Time frame: Through study completion, an average of 2 months
Quality of the relationship between the parents and their child
Time frame: Through study completion, an average of 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Denis Oriot principal investigator
Poitiers University Hospital
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 Preterm Infants and Parent-Child Relations, run by Poitiers University Hospital 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 1 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of stress of the mothers (time frame: From date of inclusion until the date of discharge, assessed up to 1 month). 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 1 Jun 2020.