Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT04995393
Status:
COMPLETED
Last Update Posted:
2021-08-16
First Post:
2021-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Heel Warming Before Capillary Blood Sampling
Sponsor:
Kolding Sygehus
Organization:
Study Overview
Official Title:
Standardization of Infants Heel Warming Before Capillary Blood Sampling - a Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: