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Clinical Trials/NCT03171844
NCT03171844CompletedNot Applicable

Early Skin to Skin in Neonatal reanimation_Risk Assessment in the Newborn With an Umbilical Venous Catheter

Centre Hospitalier Universitaire de Nice2 sites in 1 country100 target enrollmentStarted: May 31, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
2
Primary Endpoint
Bacteremia

Study Overview

Brief Summary

In the reanimation neonatal department of the Nice's hospital, 34% of newborns admitted have an umbilical vein catheter (KTVO). Their parents are admitted 24h/24h by their side, where everything is done to set up the Attachment (participation in care, skin to skin, support of breastfeeding, ...).

The benefits of skin to skin described in developmental care of the newborn in the neonatal health services are well established. Nevertheless, for supposed risks (infectious and displacement of the catheter), registered in the memory of the teams, this care is not currently carried out when the newborns are carrying an umbilical venous catheter.

Sometimes, because of the presence of an umbilical venous catheter, parents and their newborns could not enjoy this moment of well-being in the first days of life. We therefore propose a study evaluating the current risks of skin to skin with an umbilical venous catheter by reflecting on a new protocol for laying and fixing this medical device.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Newborn of gestational age less than 37SA
  • Admitted in neonatal reanimation department at Nice's hospital
  • Born in the maternity ward of the Nice's hospital
  • Carriers of an umbilical venous catheter.

Exclusion Criteria

  • All newborns with medical contraindications from skin to skin:
  • Controlled hypothermia protocol
  • Newborn under HFO (High Frequency Oscillation)
  • Carrying a diaphragmatic hernia
  • Thoracic drain holder
  • With major PAH (hypertensive pulmonary artery)
  • Symptomatic mother of acute infectious disease
  • Mother whose physical or psychiatric capacity is not compatible with travel to the neonatal reanimation service within 3 days of delivery.
  • Minor mother

Outcomes

Primary Outcomes

Bacteremia

Time Frame: 48h

Occurrence of a bacterial blood infection concomitant with Umbilical venous catheter and up to 48 hours after its withdrawal

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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