Reproducibility of a New Practical Newborn Behavioral Observation Scale (NCT02844205) | Clinical Trial Compass
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Reproducibility of a New Practical Newborn Behavioral Observation Scale
France10 participantsStarted 2015-11
Plain-language 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.
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.
Who can participate
Age range
1 Day – 60 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
assessment of the external reproductibility of a new practical newborn behavioral observation scale