Premature NewbornNCT02844205
Reproducibility of a New Practical Newborn Behavioral Observation Scale
An observational study of Premature Newborn, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Neonatal intensive care is necessary for the survival of preterm baby. Several studies show the deleterious effect on the immature brain due to stimulations caused by the environment and hospital care. Read more about this study
- Who is it for?
- Ages 1 day to 60 days
- Conditions the study is for
- Premature Newborn
- What is being tested?
- quotation of the newborn behavioral observation scale
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Dec 2016
- 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 1 day to 60 days
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infant hospitalized in intensive care unit.
Who may be able to join
- term of birth between 24 and 33 weeks of amenorrhea
- weight less than 1500g birth;
- postnatal age between 1 and 60 days
- consent form of parent in order to film their baby
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
gille Cambonie, Professor contact
France1 site, 1 recruiting
- Recruiting
University hospital of Montpellier
Montpellier, 34295
Gilles Cambonie, Professor, g-cambonie@chu-montpellier.fr
About this study
Official title: Evaluation of the Reproducibility of a New Practical Newborn Behavioral Observation Scale in Order to Implement an Individualized Care Program
Neonatal intensive care is necessary for the survival of preterm baby. Several studies show the deleterious effect on the immature brain due to stimulations caused by the environment and hospital care.
However, a specific and individualized support to the development during the first weeks of this preterm patient has a positive effect on newborn development.
Read more
A new practical newborn behavioral observation scale has been developed by the investigators care unit in order to adapt care and individualized support to the development for each patient.
The goal of this study is to estimate the external reproductibility of this scale by experimented nurse in order to implement an individualized care program.
- Conditions
- Premature Newborn
- Being tested
- quotation of the newborn behavioral observation scale
- Keywords
- nursing care, observational scale, neonate, premature infant, developmental care
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quotation of the newborn behavioral observation scaleOther
quotation of the newborn behavioral observation scale by 12 experimented nurses. Patient will be filmed during an usual care and nurses will quote the scale thanks to the video.
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of the external reproductibility of a new practical newborn behavioral observation scale
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature NewbornStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Cambonie, Professor, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844205
- Sponsor's protocol ID
- 9589
- Status last verified
- Aug 2016
- First submitted
- 18 Jul 2016
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Reproducibility of a New Practical Newborn Behavioral Observation Scale in Order to Implement an Individualized Care Program
- ClinicalTrials.gov ID
- NCT02844205
- Acronym / sponsor ID
- 9589
- Conditions
- Premature Newborn
- Keywords
- nursing care, observational scale, neonate, premature infant, developmental care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 26 Jul 2016 (estimated)
- 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.
Neonatal intensive care is necessary for the survival of preterm baby. Several studies show the deleterious effect on the immature brain due to stimulations caused by the environment and hospital care.
However, a specific and individualized support to the development during the first weeks of this preterm patient has a positive effect on newborn development.
A new practical newborn behavioral observation scale has been developed by the investigators care unit in order to adapt care and individualized support to the development for each patient.
The goal of this study is to estimate the external reproductibility of this scale by experimented nurse in order to implement an individualized care program.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 60 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infant hospitalized in intensive care unit.
Key inclusion criteria (4 listed)
- term of birth between 24 and 33 weeks of amenorrhea
- weight less than 1500g birth;
- postnatal age between 1 and 60 days
- consent form of parent in order to film their baby
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| quotation of the newborn behavioral observation scalequotation of the newborn behavioral observation scale by 12 experimented nurses. Patient will be filmed during an usual care and nurses will quote the scale thanks to the video. | Other | – |
Primary outcome
assessment of the external reproductibility of a new practical newborn behavioral observation scale
Time frame: up to 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
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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.
gille Cambonie, Professor contact
Gilles Cambonie, Professor principal investigator
University Hospital, Montpellier
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 Premature Newborn, run by University Hospital, Montpellier 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 4 inclusion and 0 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 1 Sep 2016. 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 gille Cambonie, Professor (g-cambonie@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of the external reproductibility of a new practical newborn behavioral observation scale (time frame: up to 1 hour). 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 Sep 2016.