Early Skin to Skin in Neonatal Reanimation

Not Applicable

Completed

• Conditions: Infant, Premature
• Interventions: Other: Skin to skin

• Registration Number: NCT03171844
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-29
• Study First Submitted QC: 2017-05-29
• Study Start: 2017-05-31
• Study First Posted: 2017-05-31
• Primary Completion: 2020-05-06
• Study Completion: 2020-05-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Skin to skin	Skin to skin	Implement of skin to skin

Primary Outcome Measures

Name	Time	Method
Bacteremia	48h	Occurrence of a bacterial blood infection concomitant with Umbilical venous catheter and up to 48 hours after its withdrawal

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France