Heel Warming Before Capillary Blood Sampling

August 9, 2021 updated by: Kolding Sygehus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Southern Denmark
      • Kolding, Region Southern Denmark, Denmark, 6000
        • Neonatal intensive care (NICU), Lillebaelt Hospital, University Hospital of Southern Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 hours to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glove
A heated glove containing water.
Procedure: Heating with a disposable glove containing water
Heating of the infants heel with a glove before blood sampling.
Active Comparator: Blanket
A heated blanket.
Procedure: Heating with a blanket
Heating of the infants heel with a blanket before blood sampling.
Active Comparator: Gel pack
A heated gel pack.
Procedure: Heating with a gel pack
Heating of the infants heel with a gel pack before blood sampling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speed of blood sampling
Time Frame: 10 minutes
µl blood/sec
10 minutes
Duration of blood sampling
Time Frame: 10 minutes
Sec
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemolysis index for potassium of the blood sample
Time Frame: 2 hours
2 hours
Degree of squeezing the infants foot during blood sampling
Time Frame: 1 minute
Scale 1 to 5
1 minute
Number of heel punctures required to obtain the blood sample
Time Frame: 10 minutes
1, 2, 3 or 4
10 minutes
ComfortNeo score of the infant during the blood sampling
Time Frame: 20 minutes
Pain assessment COMFORTneo score - range is 6 to 30.
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kolding Sygehus

Collaborators

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

Investigators

  • Study Director: Jonna Skov Madsen, Clinical Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark
  • Study Chair: Patricia Diana Soerensen, Clinical Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark
  • Principal Investigator: Ulla List Toennesen, Clinical Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2020

Primary Completion (Actual)

February 12, 2021

Study Completion (Actual)

February 12, 2021

Study Registration Dates

First Submitted

August 2, 2021

First Submitted That Met QC Criteria

August 2, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S-20200082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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