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Tandem: Skin-to-skin Transfer From the Delivery Room to the Neonatal Unit

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06198478
Acronym
Tandem
Enrollment
73
Registered
2024-01-10
Start date
2017-03-03
Completion date
2020-04-30
Last updated
2024-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mother-Infant Interaction, Neonatal Respiratory Distress, Preterm Birth

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.

Interventions

None listed

Sponsors

Erasme University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

s: * 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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Skin-to-skin transfer0-2 hours of lifeRate of discontinuation of the skin-to-skin was measured

Secondary

MeasureTime frameDescription
Safety of Skin-to-skin transfer - Oxygenisation0-2 hours of lifeSaturation measured in % ( considered normal \>92 %)
Safety of Skin-to-skin transfer- Temperature0-2 hours of lifeTemperature measured in Celsius ( considered normal range: 36.5-37.5 C)
Safety of Skin-to-skin transfer - Hemodynamic0-2 hours of lifeHeart rate measured in bpm (considered normal range: 120-180 bpm )
Parental and nursing satisfaction0-1 days of lifeParental and nursing satisfaction with skin-to-skin transfer via the Tandem from the delivery suite or the operating theater to the NICU were rated on a scale from 1 to 10 (10 being the most satisfied)
Breastfeeding at hospital discharge1 day (at discharge)Exclusive breastfeeding rate at discharge
Safety of Skin-to-skin transfer - Blood glucose0-2 hours of lifeBlood glucose level measured in mg/dL at least once during the first two hours of life (considered normal range: 30-100 mg/dL)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026