Clinical trial NCT04995393: Heel Warming Before Capillary Blood Sampling
Official title: Standardization of Infants Heel Warming Before Capillary Blood Sampling - a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Specimen Collection
Keywords: Blood Specimen Collection
Phlebotomy
Infant, Newborn
Heating
Heel
Pain
Lead sponsor: Kolding Sygehus
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: Development and Innovation Fund at Lillebaelt Hospital
name: The Research Council for Sygehus Lillebælt
name: Sygekassernes Helsefond
name: The Biomedical Laboratory Scientist Education and Research Fund
First posted: 2021-08-09
Enrollment: 176
Sex: ALL
Minimum age (years): 2
Maximum age (years): 77
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Speed of blood sampling
timeFrame: 10 minutes
measure: Duration of blood sampling
timeFrame: 10 minutes
Secondary outcomes:
measure: Hemolysis index for potassium of the blood sample
timeFrame: 2 hours
measure: Degree of squeezing the infants foot during blood sampling
timeFrame: 1 minute
measure: Number of heel punctures required to obtain the blood sample
timeFrame: 10 minutes
measure: ComfortNeo score of the infant during the blood sampling
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Kolding
country: Denmark
facility: Neonatal intensive care (NICU), Lillebaelt Hospital, University Hospital of Southern Denmark
state: Region Southern Denmark
Study officials:
affiliation: Clinical Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark
name: Jonna Skov Madsen
role: STUDY_DIRECTOR
affiliation: Clinical Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark
name: Patricia Diana Soerensen
role: STUDY_CHAIR
affiliation: Clinical Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark
name: Ulla List Toennesen
role: PRINCIPAL_INVESTIGATOR
References:
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