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Completed

NCT Number: NCT06198478

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

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Lung Diseases Mother-Infant Interaction Neonatal Respiratory Distress Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Pulmonary Atelectasis Respiratory Tract Diseases Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Neonatal Unit Hopital Erasme

Brussels, Anderlecht, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Safety of Skin-to-skin transfer - Hemodynamic

    Time frame: 0-2 hours of life

    Heart rate measured in bpm (considered normal range: 120-180 bpm )

  2. Safety of Skin-to-skin transfer - Oxygenisation

    Time frame: 0-2 hours of life

    Saturation measured in % ( considered normal >92 %)

  3. Safety of Skin-to-skin transfer- Temperature

    Time frame: 0-2 hours of life

    Temperature measured in Celsius ( considered normal range: 36.5-37.5 C)

  4. Safety of Skin-to-skin transfer - Blood glucose

    Time frame: 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)

  5. Parental and nursing satisfaction

    Time frame: 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)

  6. Breastfeeding at hospital discharge

    Time frame: 1 day (at discharge)

    Exclusive breastfeeding rate at discharge

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

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

Acronym: Tandem

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jan 10, 2024
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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