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Reproducibility of a New Practical Newborn Behavioral Observation Scale

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ClinicalTrials.gov Identifier: NCT02844205
Recruitment Status : Recruiting
First Posted : July 26, 2016
Last Update Posted : September 1, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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.


Condition or disease Intervention/treatment
Premature Newborn Other: quotation of the newborn behavioral observation scale

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Reproducibility of a New Practical Newborn Behavioral Observation Scale in Order to Implement an Individualized Care Program
Study Start Date : November 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Intervention Details:
  • Other: quotation of the newborn behavioral observation scale
    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.


Primary Outcome Measures :
  1. assessment of the external reproductibility of a new practical newborn behavioral observation scale [ Time Frame: up to 1 hour ]


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Ages Eligible for Study:   up to 60 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Preterm infant hospitalized in intensive care unit.
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844205


Contacts
Contact: gille Cambonie, Professor g-cambonie@chu-montpellier.fr

Locations
France
University hospital of Montpellier Recruiting
Montpellier, France, 34295
Contact: Gilles Cambonie, Professor       g-cambonie@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Gilles Cambonie, Professor University Hospital, Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02844205     History of Changes
Other Study ID Numbers: 9589
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016

Keywords provided by University Hospital, Montpellier:
nursing care
observational scale
neonate
premature infant
developmental care

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications