Heel Warming Before Capillary Blood Sampling

Study Overview
=================
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).

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

Conditions
-----------------
Blood Specimen Collection

Intervention / Treatment
-----------------
* Procedure: Heating with a disposable glove containing water
* Procedure: Heating with a blanket
* Procedure: Heating with a gel pack


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Hours
Maximum Age: 77 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Specimen Collection, Phlebotomy, Infant, Newborn, Heating, Heel, Pain