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

NCT06198478 | Completed

• 1 other identifier: P2019/510
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth; Neonatal Respiratory Distress; Mother-Infant Interaction

Outcome Measures

Primary Outcomes (1)

• Feasibility of Skin-to-skin transfer

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

  0-2 hours of life

Secondary Outcomes (6)

• Safety of Skin-to-skin transfer - Hemodynamic

  0-2 hours of life

• Safety of Skin-to-skin transfer - Oxygenisation

  0-2 hours of life

• Safety of Skin-to-skin transfer- Temperature

  0-2 hours of life

• Safety of Skin-to-skin transfer - Blood glucose

  0-2 hours of life

• Parental and nursing satisfaction

  0-1 days of life

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Neonatal Unit Hopital Erasme

Brussels, Anderlecht, 1070, Belgium

Location

Related Publications (11)

• 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.

  PMID: 32220769 BACKGROUND

• 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.

  PMID: 27885658 BACKGROUND

• 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.

  PMID: 33773829 BACKGROUND

• 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.

  PMID: 34008205 BACKGROUND

• 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.

  PMID: 15060247 BACKGROUND

• 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.

  PMID: 24246597 BACKGROUND

• 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.

  PMID: 24556982 BACKGROUND

• 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.

  PMID: 28898475 BACKGROUND

• 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.

  PMID: 27063400 BACKGROUND

• 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.

  PMID: 36333892 BACKGROUND

• 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.

  PMID: 38571704 DERIVED

MeSH Terms

Conditions

Premature Birth; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dorottya KELEN

  Erasme University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: January 10, 2024
• Study Start: March 3, 2017
• Primary Completion: December 30, 2019
• Study Completion: April 30, 2020
• Last Updated: January 10, 2024

Record last verified: 2023-11

Locations

BE (1)