NCT02844205

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 1, 2016

Status Verified

August 1, 2016

Enrollment Period

1.1 years

First QC Date

July 18, 2016

Last Update Submit

August 31, 2016

Conditions

Premature Newborn

Keywords

nursing careobservational scaleneonatepremature infantdevelopmental care

Outcome Measures

Primary Outcomes (1)

  • assessment of the external reproductibility of a new practical newborn behavioral observation scale

    up to 1 hour

Interventions

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.

Eligibility Criteria

Age1 Day - 60 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Preterm infant hospitalized in intensive care unit.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Gilles Cambonie, Professor

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

gille Cambonie, Professor

CONTACT

g-cambonie@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 26, 2016

Study Start

November 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 1, 2016

Record last verified: 2016-08

Locations

FR(1)