NCT02809664

Brief Summary

Our goal is to demonstrate the feasibility of laying uncomplicated ultrasound-guided central subclavian catheter by supraclavicular route in the newborn.

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2017

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

January 4, 2016

Last Update Submit

May 15, 2017

Conditions

Heart DiseasesDiseases, Metabolic

Outcome Measures

Primary Outcomes (1)

  • success rate without complications laying catheter ultrasound guided subclavian by supraclavicular route in newborn

    1h after intervention

Eligibility Criteria

Age43 Weeks - 44 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in the neonatal intensive care or neonatal intensive care. The 3 types of taken most often encountered load are: 1. support for prematurity at birth or poor adaptation at birth requiring intensive care or ventilatory support. 2. management of congenital heart diseases including ducto-dependent, awaiting surgery. 3. care for severe medical condition exposing one or more organ failure, between 0 and 28 days of life (severe infections, metabolic diseases, severe dehydration ...)

You may qualify if:

  • Patient hospitalized in the neonatal intensive care or neonatal intensive care at the University Hospital of Hautepierre
  • All infants less than 44 weeks corrected age who require a surgical approach
  • In the first line if neonate over 34 weeks corrected age requiring dual carriageway catheter
  • After Failure or inability laying KTEC for children between 30 and 34 weeks of age corrected and heavy over 1000

You may not qualify if:

  • Nouveau-né de poids \< 1000g
  • Nouveau-né de moins de 30 semaines d'âge corrigé
  • Choix d'une autre voie d'abord plus judicieux (KTVO, KTC broviac)
  • Sortie avant retrait du KTC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de réanimation néonatale - HOPITAL DE HAUTEPIERRE

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Heart DiseasesMetabolic Diseases

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesNutritional and Metabolic Diseases

Study Officials

  • Pierre Kuhn, MD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Kuhn, MD

CONTACT

33 3 88 12 77 86Pierre.kuhn@chru-strasbourg.fr

Olfa KOOBAR, MD

CONTACT

33 3 88 12 77 57olfa.koobar@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2016

First Posted

June 22, 2016

Study Start

October 14, 2015

Primary Completion

October 14, 2017

Study Completion

November 14, 2017

Last Updated

May 17, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)