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Clinical Trials/NCT06198478
NCT06198478
Completed
N/A

Tandem: Skin-to-skin Transfer From the Delivery Room to the Neonatal Unit for Neonates Above 1500 g

Erasme University Hospital1 site in 1 country73 target enrollmentMarch 3, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Preterm Birth
Sponsor
Erasme University Hospital
Enrollment
73
Locations
1
Primary Endpoint
Feasibility of Skin-to-skin transfer
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Immediate skin-to-skin contact (SSC) is already standard care for healthy term newborns, but its use for term or preterm newborns requiring admission to neonatal unit (NICU) with or without respiratory support is challenging. This study aimed to assess the safety and feasibility of SSC during the transfer of newborn infants, using a new purpose-built mobile shuttle care-station, called "Tandem".

A monocentric prospective observational study was conducted at the tertiary referral center of the Université libre de Bruxelles in Brussels, Belgium Infants born with a birth weight above 1500g were eligible. Following initial stabilization, infants were placed in SSC with one of their parents and transferred to the NICU using the Tandem.

Detailed Description

Prior to delivery, the trained neonatal team prepares both the Tandem and a transport incubator as a backup. Delayed umbilical cord clamping will be performed for at least one minute unless prompt resuscitation required. Then, infants will be stabilized on a resuscitation table following European Resuscitation Council guidelines, with applying electrodes for continous monitoring of heart rate, saturation and temperature. After initial stabilization respiratory support will be continued if needed using the Tandem's gas supply. In cases when, antibiotics or continuous IV glucose infusion are necessary, peripheral venous catheters will be placed before departure. In case of respiratory support, nasogastric tube will be insterted. Infants will be then transferred to the NICU under the supervision of a pediatric nurse and/or pediatrician with the Tandem in skin-to-skin position with either the mother or the father. Whenever possible, SSC will be continued for at least 120 minutes before placing the infant in an incubator. Blood glucose measurement will take place at least once during the procedure.

Registry
clinicaltrials.gov
Start Date
March 3, 2017
End Date
April 30, 2020
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Erasme University Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • neonates presenting a malformation incompatible with this type of transfer
  • neonates with invasive ventilation

Outcomes

Primary Outcomes

Feasibility of Skin-to-skin transfer

Time Frame: 0-2 hours of life

Rate of discontinuation of the skin-to-skin was measured

Secondary Outcomes

  • Safety of Skin-to-skin transfer - Oxygenisation(0-2 hours of life)
  • Safety of Skin-to-skin transfer - Hemodynamic(0-2 hours of life)
  • Parental and nursing satisfaction(0-1 days of life)
  • Breastfeeding at hospital discharge(1 day (at discharge))
  • Safety of Skin-to-skin transfer- Temperature(0-2 hours of life)
  • Safety of Skin-to-skin transfer - Blood glucose(0-2 hours of life)

Study Sites (1)

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