Reproducibility of a New Practical Newborn Behavioral Observation Scale

Premature Newborn Clinical Trial

Official title:

Evaluation of the Reproducibility of a New Practical Newborn Behavioral Observation Scale in Order to Implement an Individualized Care Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02844205
• Other study ID #: 9589
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2016
• Last updated: August 31, 2016
• Start date: November 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: University Hospital, Montpellier
• Contact: gille Cambonie, Professor
• Email: g-cambonie[@]chu-montpellier.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 60 Days

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Premature Birth
• Premature Newborn

Intervention

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.

Locations

Country	Name	City	State
France	University hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of the external reproductibility of a new practical newborn behavioral observation scale		up to 1 hour	No