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Completed

NCT Number: NCT03171844

Early Skin to Skin in Neonatal Reanimation

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.

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Key information

Conditions

Infant, Premature Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, 06003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin to Skin

Other

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

Primary outcomes

  1. Bacteremia

    Time frame: 48h

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: PA2PRéaNice

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 31, 2017
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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