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Heel Warming Before Capillary Blood Sampling

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04995393
Enrollment
176
Registered
2021-08-09
Start date
2020-08-26
Completion date
2021-02-12
Last updated
2021-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Specimen Collection

Keywords

Blood Specimen Collection, Phlebotomy, Infant, Newborn, Heating, Heel, Pain

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).

Interventions

PROCEDUREHeating with a disposable glove containing water

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

PROCEDUREHeating with a blanket

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

PROCEDUREHeating with a gel pack

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

Sponsors

Region of Southern Denmark
CollaboratorOTHER
Development and Innovation Fund at Lillebaelt Hospital
CollaboratorUNKNOWN
The Research Council for Sygehus Lillebælt
CollaboratorUNKNOWN
Sygekassernes Helsefond
CollaboratorOTHER
The Biomedical Laboratory Scientist Education and Research Fund
CollaboratorUNKNOWN
Kolding Sygehus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Also masked: Biomedical Laboratory Scientist

Eligibility

Sex/Gender
ALL
Age
2 Hours to 77 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Speed of blood sampling10 minutesµl blood/sec
Duration of blood sampling10 minutesSec

Secondary

MeasureTime frameDescription
Hemolysis index for potassium of the blood sample2 hours
Degree of squeezing the infants foot during blood sampling1 minuteScale 1 to 5
Number of heel punctures required to obtain the blood sample10 minutes1, 2, 3 or 4
ComfortNeo score of the infant during the blood sampling20 minutesPain assessment COMFORTneo score - range is 6 to 30.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026