Tandem: Skin-to-skin Transfer From the Delivery Room to the Neonatal Unit
NCT ID: NCT06198478
Last Updated: 2024-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
73 participants
OBSERVATIONAL
2017-03-03
2020-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Skin-to-skin Contact During the Transfer From the Delivery Room to the Neonatal Intensive Care Unit: Impact on Very Preterm Infants and Their Parents
NCT05820386
Respiratory Stability and Vegetative Coupling During Neonatal Skin-to-skin Care
NCT03827252
Comparison of Two Different Skin-to-skin Contact Techniques: Sustained Diagonal Flexion vs. Traditional
NCT06154148
Effect of Skin-to-skin Contact on Interaction and Parents' Sleep
NCT03004677
Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation
NCT02024854
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 with invasive ventilation
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Erasme University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dorottya KELEN
Role: PRINCIPAL_INVESTIGATOR
Erasme University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neonatal Unit Hopital Erasme
Brussels, Anderlecht, Belgium
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P2019/510
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.