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Blood Specimen CollectionNCT04995393

Heel Warming Before Capillary Blood Sampling

A study testing Heating with a disposable glove containing water, Heating with a blanket and Heating with a gel pack in people with Blood Specimen Collection, run by Kolding Sygehus at 1 site in Denmark.

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

Capillary blood sampling from the heel is often used in the treatment of infants admitted to neonatal intensive care (NICU). In Danish NICUs a heated blanket, a heated gel pad or a disposable glove with warm water are the methods most often used. Read more about this study

Who is it for?
Ages 2 hours to 77 days
Conditions the study is for
Blood Specimen Collection
What is being tested?
Heating with a disposable glove containing water, Heating with a blanket and Heating with a gel pack
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
1 siteDenmark
Study dates
26 Aug 2020to 12 Feb 2021
Phase
Interventional
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 2 hours to 77 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • PMA (postmenstrual age) ≥ 28+0
  • Blood sampling performed by a Biomedical Laboratory Scientist

Who cannot join

  • GA (gestational age) ≥ 44+0
  • Weight > 6000 g
  • Coagulation related disorder
  • Severe illness/disorder
  • Heel is bruised or swollen
  • Parents not understanding written Danish language

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Neonatal intensive care (NICU), Lillebaelt Hospital, University Hospital of Southern Denmark

    Kolding, Region Southern Denmark, 6000

Other trials in Denmark

About this study

Official title: Standardization of Infants Heel Warming Before Capillary Blood Sampling - a Randomized Controlled Study

Capillary blood sampling from the heel is often used in the treatment of infants admitted to neonatal intensive care (NICU). In Danish NICUs a heated blanket, a heated gel pad or a disposable glove with warm water are the methods most often used.

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.

Read the detailed description

Some infants experience a difficult and painful blood sampling which can lead to bruised or swollen heels and a blood sample of poor quality. To minimize the risk of that, the infant's heel is heated before the procedure as described in standard GP42-A6 from The Clinical and Laboratory Standards Institute. However, no consensus exists on which heating method to use. The aim of this study is to compare three different heating methods in terms of which method can help reduce pain experienced by infants as well as increase the quality of the blood samples.

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).

Being tested
Heating with a disposable glove containing water, Heating with a blanket, Heating with a gel pack
Keywords
Blood Specimen Collection, Phlebotomy, Infant, Newborn, Heating, Heel, Pain
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heating with a disposable glove containing waterProcedure or surgery

    Heating of the infants heel with a glove before blood sampling.

  • Heating with a blanketProcedure or surgery

    Heating of the infants heel with a blanket before blood sampling.

  • Heating with a gel packProcedure or surgery

    Heating of the infants heel with a gel pack before blood sampling.

Study groups in NCT04995393
Study groupRoleWhat they receive
GloveActive comparatorA heated glove containing water.
Receives: Procedure: Heating with a disposable glove containing water
BlanketActive comparatorA heated blanket.
Receives: Procedure: Heating with a blanket
Gel packActive comparatorA heated gel pack.
Receives: Procedure: Heating with a gel pack

What is being measured

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

  1. Speed of blood sampling

    µl blood/sec

    Measured: 10 minutes

  2. Duration of blood sampling

    Sec

    Measured: 10 minutes

Secondary outcomes (4)

  1. Hemolysis index for potassium of the blood sample

    Measured: 2 hours

  2. Degree of squeezing the infants foot during blood sampling

    Scale 1 to 5

    Measured: 1 minute

  3. Number of heel punctures required to obtain the blood sample

    1, 2, 3 or 4

    Measured: 10 minutes

  4. ComfortNeo score of the infant during the blood sampling

    Pain assessment COMFORTneo score - range is 6 to 30.

    Measured: 20 minutes

Timeline

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

  1. First posted9 Aug 2021
  2. Study start26 Aug 2020
  3. Primary completion12 Feb 2021
  4. Study completion12 Feb 2021

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04995393
Sponsor's protocol ID
S-20200082
Status last verified
Aug 2021
First submitted
2 Aug 2021
Last updated
16 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24866853

  • 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.

    PubMed 11177093

  • 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.

    PubMed 21177753

  • 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.

    PubMed 11896522

  • 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.

    PubMed 30993840

  • WHO Guidelines on Drawing Blood: Best Practices in Phlebotomy. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138650/

    PubMed 23741774

  • 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.

    PubMed 16244215

  • 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.

    PubMed 24476226

  • 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.

    PubMed 17700190

  • 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.

    PubMed 28431226

Questions about this trial

What is this clinical trial studying?

A study testing Heating with a disposable glove containing water, Heating with a blanket and Heating with a gel pack in people with Blood Specimen Collection, run by Kolding Sygehus at 1 site in Denmark.

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 2 inclusion and 6 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 16 Aug 2021. 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 Denmark. 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?

Speed of blood sampling (time frame: 10 minutes). The study lists 2 primary outcomes in all. 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 NCT04995393, which also lists 10 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 16 Aug 2021.

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