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

Preterm Birth Clinical Trial

— Tandem  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06198478
• Other study ID #: P2019/510
• Status: Completed
• Start date: March 3, 2017
• Est. completion date: April 30, 2020

Study information

• Verified date: November 2023
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: April 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criterias:

• 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

Related Conditions & MeSH terms

• Mother-Infant Interaction
• Neonatal Respiratory Distress
• Premature Birth
• Preterm Birth
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
Belgium	Neonatal Unit Hopital Erasme	Brussels	Anderlecht

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Skin-to-skin transfer	Rate of discontinuation of the skin-to-skin was measured	0-2 hours of life
Secondary	Safety of Skin-to-skin transfer - Hemodynamic	Heart rate measured in bpm (considered normal range: 120-180 bpm )	0-2 hours of life
Secondary	Safety of Skin-to-skin transfer - Oxygenisation	Saturation measured in % ( considered normal >92 %)	0-2 hours of life
Secondary	Safety of Skin-to-skin transfer- Temperature	Temperature measured in Celsius ( considered normal range: 36.5-37.5 C)	0-2 hours of life
Secondary	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)	0-2 hours of life
Secondary	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)	0-1 days of life
Secondary	Breastfeeding at hospital discharge	Exclusive breastfeeding rate at discharge	1 day (at discharge)