Clinical trial NCT06198478: Tandem: Skin-to-skin Transfer From the Delivery Room to the Neonatal Unit
Official title: Tandem: Skin-to-skin Transfer From the Delivery Room to the Neonatal Unit for Neonates Above 1500 g
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Neonatal Respiratory Distress
Mother-Infant Interaction
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 73
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates over 31 weeks of gestational age and over 1500 grams requiring admission to the neonatal unit

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.

Eligibility criteria: Inclusion Criterias:

* neonates with an estimated foetal weight above1500 grams
* neonates requiring admission to the neonatal intensive care unit
* neonates requiring or not non-invasive respiratory support
* neonates with at least one parent who has a good understanding of the method of transfer

Exclusion Criteria:

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

Primary outcomes:
measure: Feasibility of Skin-to-skin transfer
timeFrame: 0-2 hours of life
Secondary outcomes:
measure: Safety of Skin-to-skin transfer - Hemodynamic
timeFrame: 0-2 hours of life
measure: Safety of Skin-to-skin transfer - Oxygenisation
timeFrame: 0-2 hours of life
measure: Safety of Skin-to-skin transfer- Temperature
timeFrame: 0-2 hours of life
measure: Safety of Skin-to-skin transfer - Blood glucose
timeFrame: 0-2 hours of life
measure: Parental and nursing satisfaction
timeFrame: 0-1 days of life
measure: Breastfeeding at hospital discharge
timeFrame: 1 day (at discharge)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Neonatal Unit Hopital Erasme
state: Anderlecht
Study officials:
affiliation: Erasme University Hospital
name: Dorottya KELEN
role: PRINCIPAL_INVESTIGATOR
References:
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