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Early Skin to Skin in Neonatal Reanimation (PA2PRéaNice)

C

Centre Hospitalier Universitaire de Nice

Status

Completed

Conditions

Infant, Premature

Treatments

Other: Skin to skin

Study type

Interventional

Funder types

Other

Identifiers

NCT03171844
16-AOI-01

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Skin to skin
Experimental group
Description:
Implement of skin to skin
Treatment:
Other: Skin to skin

Trial contacts and locations

1

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Central trial contact

Florence CASAGRANDE, MD

Data sourced from clinicaltrials.gov

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