Heel Warming Before Capillary Blood Sampling

Blood Specimen Collection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04995393
• Other study ID #: S-20200082
• Status: Completed
• Phase: N/A
• Start date: August 26, 2020
• Est. completion date: February 12, 2021

Study information

• Verified date: August 2021
• Source: Kolding Sygehus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: February 12, 2021
• Est. primary completion date: February 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 77 Days

Eligibility

Inclusion Criteria:

• PMA (postmenstrual age) = 28+0

• Blood sampling performed by a Biomedical Laboratory Scientist

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Blood Specimen Collection

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Denmark	Neonatal intensive care (NICU), Lillebaelt Hospital, University Hospital of Southern Denmark	Kolding	Region Southern Denmark

Sponsors (6)

Lead Sponsor	Collaborator
Kolding Sygehus	Development and Innovation Fund at Lillebaelt Hospital, Open Patient data Explorative Network, Sygekassernes Helsefond, The Biomedical Laboratory Scientist Education and Research Fund, The Research Council for Sygehus Lillebælt

Country where clinical trial is conducted

Denmark, 

References & Publications (10)

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. Review. — View Citation

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. — View Citation

Folk LA. Guide to capillary heelstick blood sampling in infants. Adv Neonatal Care. 2007 Aug;7(4):171-8. Review. — View Citation

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. — View Citation

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. — View Citation

Losacco V, Cuttini M, Greisen G, Haumont D, Pallás-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. Erratum in: Arch Dis Child Fetal Neonatal Ed. 2011 Feb;96(2):207. Arch Dis Child Fetal Neonatal Ed. 2012 Jun;97(6):583. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

WHO Guidelines on Drawing Blood: Best Practices in Phlebotomy. Geneva: World Health Organization; 2010. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speed of blood sampling	µl blood/sec	10 minutes
Primary	Duration of blood sampling	Sec	10 minutes
Secondary	Hemolysis index for potassium of the blood sample		2 hours
Secondary	Degree of squeezing the infants foot during blood sampling	Scale 1 to 5	1 minute
Secondary	Number of heel punctures required to obtain the blood sample	1, 2, 3 or 4	10 minutes
Secondary	ComfortNeo score of the infant during the blood sampling	Pain assessment COMFORTneo score - range is 6 to 30.	20 minutes