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Preterm BirthTandemNCT06198478

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

An observational study of Preterm Birth and Neonatal Respiratory Distress, run by Erasme University Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
How many people
73 participants
Where
1 siteBelgium
Study dates
3 Mar 2017to 30 Apr 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Neonates over 31 weeks of gestational age and over 1500 grams requiring admission to the neonatal unit

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Neonatal Unit Hopital Erasme

    Brussels, Anderlecht, 1070

Other trials in Belgium

About this study

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

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.

Read the 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.

Medical subject headings
Premature Birth, Pulmonary Atelectasis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Skin-to-skin transfer

    Rate of discontinuation of the skin-to-skin was measured

    Measured: 0-2 hours of life

Secondary outcomes (6)

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

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

    Measured: 0-2 hours of life

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

    Saturation measured in % ( considered normal >92 %)

    Measured: 0-2 hours of life

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

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

    Measured: 0-2 hours of life

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

    Blood glucose level measured in mg/dL at least once during the first two hours of life (considered normal range: 30-100 mg/dL)

    Measured: 0-2 hours of life

  5. Parental and nursing satisfaction

    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)

    Measured: 0-1 days of life

  6. Breastfeeding at hospital discharge

    Exclusive breastfeeding rate at discharge

    Measured: 1 day (at discharge)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2024
  2. Study start3 Mar 2017
  3. Primary completion30 Dec 2019
  4. Study completion30 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06198478
Sponsor's protocol ID
P2019/510
Acronym
Tandem
Status last verified
Nov 2023
First submitted
30 Nov 2023
Last updated
10 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Agudelo S, Diaz D, Maldonado MJ, Acuna E, Mainero D, Perez O, Perez L, Molina C. Effect of skin-to-skin contact at birth on early neonatal hospitalization. Early Hum Dev. 2020 May;144:105020. doi: 10.1016/j.earlhumdev.2020.105020. Epub 2020 Mar 25.

    PubMed 32220769

  • Moore ER, Bergman N, Anderson GC, Medley N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2016 Nov 25;11(11):CD003519. doi: 10.1002/14651858.CD003519.pub4.

    PubMed 27885658

  • Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rudiger M, Skare C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation. 2021 Apr;161:291-326. doi: 10.1016/j.resuscitation.2021.02.014. Epub 2021 Mar 24.

    PubMed 33773829

  • van den Berg J, Jakobsson U, Selander B, Lundqvist P. Exploring physiological stability of infants in Kangaroo Mother Care position versus placed in transport incubator during neonatal ground ambulance transport in Sweden. Scand J Caring Sci. 2022 Dec;36(4):997-1005. doi: 10.1111/scs.13000. Epub 2021 May 18.

    PubMed 34008205

  • Sontheimer D, Fischer CB, Buch KE. Kangaroo transport instead of incubator transport. Pediatrics. 2004 Apr;113(4):920-3. doi: 10.1542/peds.113.4.920.

    PubMed 15060247

  • Mitchell AJ, Yates C, Williams K, Hall RW. Effects of daily kangaroo care on cardiorespiratory parameters in preterm infants. J Neonatal Perinatal Med. 2013;6(3):243-9. doi: 10.3233/NPM-1370513.

    PubMed 24246597

  • Nimbalkar SM, Patel VK, Patel DV, Nimbalkar AS, Sethi A, Phatak A. Effect of early skin-to-skin contact following normal delivery on incidence of hypothermia in neonates more than 1800 g: randomized control trial. J Perinatol. 2014 May;34(5):364-8. doi: 10.1038/jp.2014.15. Epub 2014 Feb 20.

    PubMed 24556982

  • Hennequin Y, Grevesse L, Gylbert D, Albertyn V, Hermans S, Van Overmeire B. Skin-to-skin back transfers provide a feasible, safe and low-stress alternative to conventional neonatal transport. Acta Paediatr. 2018 Jan;107(1):163-164. doi: 10.1111/apa.14071. Epub 2017 Oct 2. No abstract available.

    PubMed 28898475

  • Kristoffersen L, Stoen R, Hansen LF, Wilhelmsen J, Bergseng H. Skin-to-Skin Care After Birth for Moderately Preterm Infants. J Obstet Gynecol Neonatal Nurs. 2016 May-Jun;45(3):339-45. doi: 10.1016/j.jogn.2016.02.007. Epub 2016 Apr 7.

    PubMed 27063400

  • Lode-Kolz K, Hermansson C, Linner A, Klemming S, Hetland HB, Bergman N, Lillieskold S, Pike HM, Westrup B, Jonas W, Rettedal S. Immediate skin-to-skin contact after birth ensures stable thermoregulation in very preterm infants in high-resource settings. Acta Paediatr. 2023 May;112(5):934-941. doi: 10.1111/apa.16590. Epub 2022 Nov 18.

    PubMed 36333892

  • M'Rini M, De Doncker L, Huet E, Rochez C, Kelen D. Skin-to-skin transfer from the delivery room to the neonatal unit for neonates of 1,500g or above: a feasibility and safety study. Front Pediatr. 2024 Mar 20;12:1379763. doi: 10.3389/fped.2024.1379763. eCollection 2024.

    PubMed 38571704

Questions about this trial

What is this clinical trial studying?

An observational study of Preterm Birth and Neonatal Respiratory Distress, run by Erasme University Hospital at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Skin-to-skin transfer (time frame: 0-2 hours of life). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06198478, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.

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