Early Skin to Skin in Neonatal Reanimation

Infant, Premature Clinical Trial

— PA2PRéaNice  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03171844
• Other study ID #: 16-AOI-01
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Infant, Premature

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