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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06198478
Study type	Observational
Source	Erasme University Hospital
Contact
Status	Completed
Phase
Start date	March 3, 2017
Completion date	April 30, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms