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

Completed

• Conditions: Preterm Birth; Mother-Infant Interaction; Neonatal Respiratory Distress

• Registration Number: NCT06198478
• Lead Sponsor: Erasme University Hospital

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.

Study Timeline

• Study Start: 2017-03-03
• Primary Completion: 2019-12-30
• Study Completion: 2020-04-30
• Status Verified: 2023-11
• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Study First Posted: 2024-01-10
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of Skin-to-skin transfer	0-2 hours of life	Rate of discontinuation of the skin-to-skin was measured

Secondary Outcome Measures

Name	Time	Method
Safety of Skin-to-skin transfer - Oxygenisation	0-2 hours of life	Saturation measured in % ( considered normal \>92 %)
Parental and nursing satisfaction	0-1 days of life	Parental 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)
Safety of Skin-to-skin transfer - Hemodynamic	0-2 hours of life	Heart rate measured in bpm (considered normal range: 120-180 bpm )
Breastfeeding at hospital discharge	1 day (at discharge)	Exclusive breastfeeding rate at discharge
Safety of Skin-to-skin transfer- Temperature	0-2 hours of life	Temperature measured in Celsius ( considered normal range: 36.5-37.5 C)
Safety of Skin-to-skin transfer - Blood glucose	0-2 hours of life	Blood glucose level measured in mg/dL at least once during the first two hours of life (considered normal range: 30-100 mg/dL)

Trial Locations

Locations (1)

Neonatal Unit Hopital Erasme; 🇧🇪 Brussels, Anderlecht, Belgium