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Completed

NCT Number: NCT04995393

Heel Warming Before Capillary Blood Sampling

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.

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Key information

Age range

2 hour–77 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Kolding, Region Southern Denmark, 6000, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heating with a disposable glove containing water

Procedure

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

Heating with a blanket

Procedure

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

Heating with a gel pack

Procedure

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

Primary outcomes

  1. Speed of blood sampling

    Time frame: 10 minutes

    µl blood/sec

  2. Duration of blood sampling

    Time frame: 10 minutes

    Sec

Secondary outcomes

  1. Hemolysis index for potassium of the blood sample

    Time frame: 2 hours

  2. Degree of squeezing the infants foot during blood sampling

    Time frame: 1 minute

    Scale 1 to 5

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

    Time frame: 10 minutes

    1, 2, 3 or 4

  4. ComfortNeo score of the infant during the blood sampling

    Time frame: 20 minutes

    Pain assessment COMFORTneo score - range is 6 to 30.

Sponsors and collaborators

Lead sponsor

Kolding Sygehus

Other

Collaborators

  • Development and Innovation Fund at Lillebaelt Hospital
  • Region of Southern Denmark
  • Sygekassernes Helsefond
  • The Biomedical Laboratory Scientist Education and Research Fund
  • The Research Council for Sygehus Lillebælt

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 9, 2021
Registry last updated
Aug 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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