Early Skin to Skin in Neonatal Reanimation

NCT03171844 | Completed

• 1 other identifier: 16-AOI-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Premature

Outcome Measures

Primary Outcomes (1)

• Bacteremia

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

  48h

Study Arms (1)

Skin to skin

EXPERIMENTAL

Implement of skin to skin

Other: Skin to skin

Interventions

Skin to skin OTHER

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

Skin to skin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06003, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Florence CASAGRANDE, MD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: May 31, 2017
• Study Start: May 31, 2017
• Primary Completion: May 6, 2020
• Study Completion: May 6, 2020
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

FR (1)