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
NA
176 participants
INTERVENTIONAL
2020-08-26
2021-02-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this randomized controlled study is to investigate which of the mentioned heating methods ensures the best quality of the blood sample and provides the most gentle blood sampling for the infant.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Blood Warming in Preterm Infants to Decrease Hypothermia
NCT05170633
Skin Temperature Changes When Using a Cryocompression Device
NCT05136482
Effect of Pressure on Skin Temperature When Using a Cryocompression Device
NCT05454982
10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature
NCT04991272
Evaluation of a Patient Warming Concept Following the German S3 Guideline for Prevention of Intraoperative Hypothermia
NCT02206997
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Infants (postmenstrual age ≥ 28 + 0) admitted to the NICU, Kolding Hospital and having a blood sample taken by a Biomedical Laboratory Scientist are invited to participate. A parental informed concent must be signed by both parents before participation.
Infants are randomized to one of the three heating methods: glove, blanket or gel pad.
The following blood sampling procedure is closely monitored to register data corresponding to the five outcome measures.
Furthermore the infants personal data, location of the infant during the procedure, surface temperature of the heel before and after heating, volume of sampled blood, sign of bruises and swelling as well as hematocrit are registered.
Data registration, web-based block randomization, data storage and statistical analysis are supported by OPEN (Open Patient data Explorative Network, University of Southern Denmark).
The study is registered as public research at the Region of Southern Denmark (journal no. 20/1316) and is approved by The Regional Committees on Health Research Ethics for Southern Denmark (ID S-20200082).
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.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Glove
A heated glove containing water.
Heating with a disposable glove containing water
Heating of the infants heel with a glove before blood sampling.
Blanket
A heated blanket.
Heating with a blanket
Heating of the infants heel with a blanket before blood sampling.
Gel pack
A heated gel pack.
Heating with a gel pack
Heating of the infants heel with a gel pack before blood sampling.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Heating with a disposable glove containing water
Heating of the infants heel with a glove before blood sampling.
Heating with a blanket
Heating of the infants heel with a blanket before blood sampling.
Heating with a gel pack
Heating of the infants heel with a gel pack before blood sampling.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Blood sampling performed by a Biomedical Laboratory Scientist
Exclusion Criteria
* Weight \> 6000 g
* Coagulation related disorder
* Severe illness/disorder
* Heel is bruised or swollen
* Parents not understanding written Danish language
2 Hours
77 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Region of Southern Denmark
OTHER
Development and Innovation Fund at Lillebaelt Hospital
UNKNOWN
The Research Council for Sygehus Lillebælt
UNKNOWN
Sygekassernes Helsefond
OTHER
The Biomedical Laboratory Scientist Education and Research Fund
UNKNOWN
Kolding Sygehus
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.
Jonna Skov Madsen
Role: STUDY_DIRECTOR
Clinical Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark
Patricia Diana Soerensen
Role: STUDY_CHAIR
Clinical Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark
Ulla List Toennesen
Role: PRINCIPAL_INVESTIGATOR
Clinical Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neonatal intensive care (NICU), Lillebaelt Hospital, University Hospital of Southern Denmark
Kolding, Region Southern Denmark, Denmark
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.
Valeri BO, Holsti L, Linhares MB. Neonatal pain and developmental outcomes in children born preterm: a systematic review. Clin J Pain. 2015 Apr;31(4):355-62. doi: 10.1097/AJP.0000000000000114.
Anand KJ; International Evidence-Based Group for Neonatal Pain. Consensus statement for the prevention and management of pain in the newborn. Arch Pediatr Adolesc Med. 2001 Feb;155(2):173-80. doi: 10.1001/archpedi.155.2.173.
Losacco V, Cuttini M, Greisen G, Haumont D, Pallas-Alonso CR, Pierrat V, Warren I, Smit BJ, Westrup B, Sizun J; ESF Network. Heel blood sampling in European neonatal intensive care units: compliance with pain management guidelines. Arch Dis Child Fetal Neonatal Ed. 2011 Jan;96(1):F65-8. doi: 10.1136/adc.2010.186429.
Janes M, Pinelli J, Landry S, Downey S, Paes B. Comparison of capillary blood sampling using an automated incision device with and without warming the heel. J Perinatol. 2002 Mar;22(2):154-8. doi: 10.1038/sj.jp.7210583.
Aydin D, Inal S. Effects of breastfeeding and heel warming on pain levels during heel stick in neonates. Int J Nurs Pract. 2019 Jun;25(3):e12734. doi: 10.1111/ijn.12734. Epub 2019 Apr 17.
WHO Guidelines on Drawing Blood: Best Practices in Phlebotomy. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138650/
Hassan Z, Shah M. Scald injury from the Guthrie test: should the heel be warmed? Arch Dis Child Fetal Neonatal Ed. 2005 Nov;90(6):F533-4. doi: 10.1136/adc.2005.072678.
Shu SH, Lee YL, Hayter M, Wang RH. Efficacy of swaddling and heel warming on pain response to heel stick in neonates: a randomised control trial. J Clin Nurs. 2014 Nov;23(21-22):3107-14. doi: 10.1111/jocn.12549. Epub 2014 Jan 30.
Folk LA. Guide to capillary heelstick blood sampling in infants. Adv Neonatal Care. 2007 Aug;7(4):171-8. doi: 10.1097/01.ANC.0000286333.67928.04.
Sorrentino G, Fumagalli M, Milani S, Cortinovis I, Zorz A, Cavallaro G, Mosca F, Plevani L. The impact of automatic devices for capillary blood collection on efficiency and pain response in newborns: A randomized controlled trial. Int J Nurs Stud. 2017 Jul;72:24-29. doi: 10.1016/j.ijnurstu.2017.04.001. Epub 2017 Apr 11.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S-20200082
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.