Early Skin to Skin in Neonatal Reanimation

NCT ID: NCT03171844

Last Updated: 2023-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-31

Study Completion Date

2020-05-06

Brief Summary

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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

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Conditions

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Infant, Premature

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Skin to skin

Implement of skin to skin

Group Type EXPERIMENTAL

Skin to skin

Intervention Type OTHER

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

Interventions

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Skin to skin

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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florence CASAGRANDE, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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CHU de Nice

Nice, , France

Site Status

Countries

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France

Other Identifiers

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16-AOI-01

Identifier Type: -

Identifier Source: org_study_id

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