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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03171844
Other study ID # 16-AOI-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 31, 2017
Est. completion date May 6, 2020

Study information

Verified date November 2023
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 6, 2020
Est. primary completion date May 6, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Skin to skin
3 sessions of skin to skin will be made on newborn wearing an umbilical venous catheter

Locations

Country Name City State
France CHU de Nice Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bacteremia Occurrence of a bacterial blood infection concomitant with Umbilical venous catheter and up to 48 hours after its withdrawal 48h
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