Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04811612
Status:
UNKNOWN
Last Update Posted:
2021-03-23
First Post:
2021-03-20
Brief Title:
Comparing Heel Stick Glucoses in Neonates
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
Comparison of Warmed and Un-warmed Heel Stick Capillary Blood Glucose Samples in Neonates
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
NOT_YET_RECRUITING
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:
CHECK IN
Brief Summary:
Newborn babies can develop low blood sugar glucose which can lead to brain injury and poor developmental outcomes Therefore it is important to accurately measure the blood glucose in babies One way to measure the blood glucose is to test blood from the babys heel with a bedside device called a point of care glucometer This method is very common and easy however multiple factors can lead to an inaccurate reading A false low reading may require additional blood testing and admission to the NICU A false high reading could result in the medical provider missing the diagnosis of low blood glucose
Our team wants to know if there is a difference between blood glucose measurements taken from warmed and un-warmed heels of infants Blood flow farther away from the heart such as in the feet and heels may be less than the rest of the body and might move more slowly This could cause the glucose level to be lower in the feet and heels Therefore sampling blood from an un-warmed heel may result in a falsely low glucose reading
There is some research that suggests warming the heel increases blood flow to the area however only one study that we know of has evaluated differences in blood glucose readings from warmed and un-warmed heels They found significantly higher blood glucose readings from warmed heels compared to un-warmed heels in 57 babies However these babies were part of a larger study comparing different diets on blood glucose levels and the heels were warmed using warm water which is no longer a current practice The goal of this study is to compare the capillary blood glucose levels from warmed and un-warmed heels in about 100 infants who are breast andor formula fed using the current practice of warming heels with gel heat packs
The null hypothesis is that there will be no difference between capillary blood glucose levels sampled from an infants warmed and un-warmed heel The alternative hypothesis is that capillary blood glucose levels sampled from warmed heels will be higher than those samples from un-warmed heels
Our team wants to know if there is a difference between blood glucose measurements taken from warmed and un-warmed heels of infants Blood flow farther away from the heart such as in the feet and heels may be less than the rest of the body and might move more slowly This could cause the glucose level to be lower in the feet and heels Therefore sampling blood from an un-warmed heel may result in a falsely low glucose reading
There is some research that suggests warming the heel increases blood flow to the area however only one study that we know of has evaluated differences in blood glucose readings from warmed and un-warmed heels They found significantly higher blood glucose readings from warmed heels compared to un-warmed heels in 57 babies However these babies were part of a larger study comparing different diets on blood glucose levels and the heels were warmed using warm water which is no longer a current practice The goal of this study is to compare the capillary blood glucose levels from warmed and un-warmed heels in about 100 infants who are breast andor formula fed using the current practice of warming heels with gel heat packs
The null hypothesis is that there will be no difference between capillary blood glucose levels sampled from an infants warmed and un-warmed heel The alternative hypothesis is that capillary blood glucose levels sampled from warmed heels will be higher than those samples from un-warmed heels
Detailed Description:
Neonatal hypoglycemia is defined by the American Academy of Pediatrics as blood glucose level less than 47 mgdL and is one of the most common diagnoses requiring admission to the neonatal intensive care unit NICU12 The incidence of hypoglycemia in healthy newborns is approximately 5-15 and as high as 51 in infants with risk factors3 The cost of hospitalization of neonatal hypoglycemia is estimated to range from 2350-127554 Hypoglycemia in the newborn has been associated with permanent brain injury including neurodevelopmental delay learning difficulties and seizures5 Clinically important hypoglycemia is not always associated with clinical exam findings6 therefore accurate measurement of blood glucose in the newborn is of great importance
Laboratory testing of venous blood typically plasma is a widely accepted method of diagnosing neonatal hypoglycemia6 However point of care POC testing of capillary blood using a bedside glucometer is a common screening tool in newborn nurseries and NICUs The POC testing method provides real time results and is an easier less invasive sampling technique6 Despite these conveniences studies have found POC testing to be less accurate than venous testing7-9 POC testing is also less accurate at lower glucose levels and readings are affected by polycythemia and hyperbilirubinemia common findings in newborn babies6710 Inaccurate readings may result in unnecessary admissions to the NICU for additional testing and management Therefore efforts to optimize the accuracy POC glucose testing in screening for neonatal hypoglycemia is imperative
One common practice thought to increase the accuracy of capillary POC glucose testing is to warm the infants heel before blood sampling It has been proposed that warming the heel will increase blood flow to the capillary bed and improve peripheral blood stasis that may otherwise result in a falsely low glucose reading1112 Current practice is to warm the heel with a gel heat pack designed and marketed specifically for the purpose of warming the infants heel prior to blood collection These gel heat packs are an additional cost to the hospital and currently it is unclear if there is any significant clinical benefit to warming the infants heel before obtaining capillary blood glucose measurements
Various studies utilizing laser Doppler flowmetry have suggested that local warming results in increased skin blood flow and perfusion in infants13-15 This increase in blood flow is thought to be reflected in the volume of blood collected and ease of collection In practice however the effect of local warming on capillary blood collection in neonates appears to be minimal One study found that heel warming in infants did not improve the volume of blood collected or the ease of blood collection16 A subsequent study found that warming the heel decreased the need to squeeze the heel for blood collection however there was no difference in volume of blood collected or collection time17 To the best of our knowledge the only study that has directly compared the effect of warming the heel on capillary blood glucose in infants was conducted by Russell and McKay in 196618 The study compared simultaneously collected capillary blood glucose levels from a warmed and un-warmed heel in 57 infants Overall glucose levels from the warmed and un-warmed heels were highly significantly correlated However the mean glucose concentration from blood in warmed heels was 28 mgdL higher than that from un-warmed heels Additionally of the 57 infants 13 had a statistically significant higher glucose level measured in their warmed heel compared to their un-warmed heel
The Russell and McKay study suggested that the infants heel must always be warmed before collecting capillary blood for glucose measurement However the study included only 57 infants a subset of which were also assigned to a low calorie high calorie or hydrocortisone administration groups to determine the outcomes of these interventions on blood glucose levels Additionally the infants heels were warmed by soaking in warm water This is no longer the current practice as most institutions use gel heat packs designed specifically for warming the heels of infants
The goal of this study is to simultaneously compare the capillary blood glucose levels from warmed and un-warmed heels in approximately 100 infants who are being breast andor formula fed using the current practice of warming heels with gel heat packs The null hypothesis is that there will be no difference between capillary blood glucose levels sampled from an infants warmed and un-warmed heel It has been proposed that warming the heel will increase blood flow to the capillary bed and improve peripheral blood stasis that may otherwise result in a falsely low glucose reading Therefore the alternative hypothesis is that capillary blood glucose levels sampled from warmed heels will be higher than those samples from un-warmed heels
After admission to the newborn nursery or NICU the infants mother will be approached regarding her participation and of her newborn baby If participation is desired mom will sign consent for herself and for the infant PHI authorization will be obtained Warmed and un-warmed heel capillary blood glucose will be obtained from the infant at the time of a clinically indicated point of care glucose check A heating pad will be placed on one heel for 10 minutes The other heel will not be warmed A lancet will be used to produce blood at both heels and blood glucose will be measured from both heels using the Nova Stat glucometer
Data from the hospitalization will be extracted from the Electronic Health Record from both mother and baby Data will include demographic information medications and health conditions delivery information and anthropometric data Data analysis will be done using SPSS Statistic software to evaluate for differences between capillary blood glucose levels from warmed and unwarmed heels
1 Thompson-Branch A and Havranek T Neonatal Hypoglycemia Pediatr Rev April 2017384147-157 DOI httpsdoiorg101542pir2016-0063
2 Alsaleem M Saadeh L and Kamat D Neonatal Hypoglycemia A Review Clin Pediatr Phila 2019 Nov58131381-1386 doi 1011770009922819875540 Epub 2019 Sep 26
3 Hosagasi NH Aydein M Zenciroglu A Ustun N and Beken S Incidence of hypoglycemia in newborns at risk and an audit of the 2011 American academy of pediatrics guideline for hypoglycemia Pediatr Neonatl 2018 Aug594368-374 doi 101016jpedneo201711009 Epup 2017 Nov 15
4 Alemu BT Beydoun HA Hoch M Van Lunen B and Akpinar-Elci M Hospitalization cost in infants with hypoglycemia Curr Pediatr Res Dec 2018224
5 Rozance PJ and Wolfsdorf JI Hypoglycemia in the Newborn Pediatr Clin North Am Apr 2019662333-342 doi 101016jpcl201812004 Epub 2019 Feb 1
6 Beardsall K Measurement of glucose levels in the newborn Early Hum Dev May 2010865263-267 doi 101016jearlhumdev201005005 Epub 2010 Jun 9
7 Hussain K and Sharief N The inaccuracy of venous and capillary blood glucose measurement using reagent strips in the newborn period and the effect of haematocrit Early Hum Dev 2000 Feb572111-21 doi 101016s0378-37829900060-2
8 Ameur K et al Evaluation of the measurement of capillary glucose concentration versus plasma glucose in the newborn Arch Pediatr 2016 Sep239908-12 doi101016jarcped201604025 Epub 2016 Jun 28
9 Balion C Grey V Ismaila A Blatz S and Seidlitz W Screening for hypoglycemia at the bedside in the neonatal intensive care unit NICU with the Abbott PCx glucose meter BMC Pediatr 2006 Nov 3628 doi 1011861471-2431-6-28
10 Hamid MH Chrishti AL and Maqbool S Clinical utility and accuracy of a blood glucose meter for the detection of neonatal hypoglycemia J Coll Physicians Surg Pak 2004 Apr144225-8
11 Short BL Capillary blood sampling In Fletcher MA MacDonald MG eds Adas of procedures in neonatology Philadelphia J B Lippincott Co 1993 97-100
12 Meites S Skin-puncture and blood-collecting technique for infants update and problems Clin Chem 1988 Sep3491890-4
13 Suichies HE Brouwer C Aarnoudse JG Jentink HW de Mul FFM and Greve J Skin blood flow changes measured by laser doppler flowmetry in the first week after birth Early Hum Devel 1990 23 1-8
14 Takayanagi T Fukunda M Nakazawa M Tanaka S and Yoshinaga M Response of skin blood volume velocity and flow to local warming in newborns measured by laser Doppler flowmetry Pediatr Int 1999 Dec416624-30 doi 101046j1442-200x199901145x
15 Beinder E Trojan A Bucher HU Huch A and Huch R Control of skin blood flow in pre- and full- term infants Biol Neonate 19946517-15 doi 101159000244021
16 Barker DP Willetts B Cappendjik VC and Rutter N Capillary blood sampling should the heel be warmed Arch Dis Child 199674139-40
17 Janes M Pinelli J Landry S Downey S and Paes B Comparison of capillary blood sampling using an automated incision device with and without warming of the heel J Perinatol 200222154-58
18 Russell G and McKay E Blood Glucose Concentration in the Perinatal Period Arch Dis Child 1966 Oct41496-502s0378-37829900060-2
8 Ameur K et al Evaluation of the measurement of capillary glucose concentration versus plasma glucose in the newborn Arch Pediatr 2016 Sep239908-12 doi101016jarcped201604025 Epub 2016 Jun 28
9 Balion C Grey V Ismaila A Blatz S and Seidlitz W Screening for hypoglycemia at the bedside in the neonatal intensive care unit NICU with the Abbott PCx glucose meter BMC Pediatr 2006 Nov 3628 doi 1011861471-2431-6-28
10 Hamid MH Chrishti AL and Maqbool S Clinical utility and accuracy of a blood glucose meter for the detection of neonatal hypoglycemia J Coll Physicians Surg Pak 2004 Apr144225-8
11 Short BL Capillary blood sampling In Fletcher MA MacDonald MG eds Adas of procedures in neonatology Philadelphia J B Lippincott Co 1993 97-100
12 Meites S Skin-puncture and blood-collecting technique for infants update and problems Clin Chem 1988 Sep3491890-4
13 Suichies HE Brouwer C Aarnoudse JG Jentink HW de Mul FFM and Greve J Skin blood flow changes measured by laser doppler flowmetry in the first week after birth Early Hum Devel 1990 23 1-8
14 Takayanagi T Fukunda M Nakazawa M Tanaka S and Yoshinaga M Response of skin blood volume velocity and flow to local warming in newborns measured by laser Doppler flowmetry Pediatr Int 1999 Dec416624-30 doi 101046j1442-200x199901145x
15 Beinder E Trojan A Bucher HU Huch A and Huch R Control of skin blood flow in pre- and full- term infants Biol Neonate 19946517-15 doi 101159000244021
16 Barker DP Willetts B Cappendjik VC and Rutter N Capillary blood sampling should the heel be warmed Arch Dis Child 199674139-40
17 Janes M Pinelli J Landry S Downey S and Paes B Comparison of capillary blood sampling using an automated incision device with and without warming of the heel J Perinatol 200222154-58
18 Russell G and McKay E Blood Glucose Concentration in the Perinatal Period Arch Dis Child 1966 Oct41496-502
Laboratory testing of venous blood typically plasma is a widely accepted method of diagnosing neonatal hypoglycemia6 However point of care POC testing of capillary blood using a bedside glucometer is a common screening tool in newborn nurseries and NICUs The POC testing method provides real time results and is an easier less invasive sampling technique6 Despite these conveniences studies have found POC testing to be less accurate than venous testing7-9 POC testing is also less accurate at lower glucose levels and readings are affected by polycythemia and hyperbilirubinemia common findings in newborn babies6710 Inaccurate readings may result in unnecessary admissions to the NICU for additional testing and management Therefore efforts to optimize the accuracy POC glucose testing in screening for neonatal hypoglycemia is imperative
One common practice thought to increase the accuracy of capillary POC glucose testing is to warm the infants heel before blood sampling It has been proposed that warming the heel will increase blood flow to the capillary bed and improve peripheral blood stasis that may otherwise result in a falsely low glucose reading1112 Current practice is to warm the heel with a gel heat pack designed and marketed specifically for the purpose of warming the infants heel prior to blood collection These gel heat packs are an additional cost to the hospital and currently it is unclear if there is any significant clinical benefit to warming the infants heel before obtaining capillary blood glucose measurements
Various studies utilizing laser Doppler flowmetry have suggested that local warming results in increased skin blood flow and perfusion in infants13-15 This increase in blood flow is thought to be reflected in the volume of blood collected and ease of collection In practice however the effect of local warming on capillary blood collection in neonates appears to be minimal One study found that heel warming in infants did not improve the volume of blood collected or the ease of blood collection16 A subsequent study found that warming the heel decreased the need to squeeze the heel for blood collection however there was no difference in volume of blood collected or collection time17 To the best of our knowledge the only study that has directly compared the effect of warming the heel on capillary blood glucose in infants was conducted by Russell and McKay in 196618 The study compared simultaneously collected capillary blood glucose levels from a warmed and un-warmed heel in 57 infants Overall glucose levels from the warmed and un-warmed heels were highly significantly correlated However the mean glucose concentration from blood in warmed heels was 28 mgdL higher than that from un-warmed heels Additionally of the 57 infants 13 had a statistically significant higher glucose level measured in their warmed heel compared to their un-warmed heel
The Russell and McKay study suggested that the infants heel must always be warmed before collecting capillary blood for glucose measurement However the study included only 57 infants a subset of which were also assigned to a low calorie high calorie or hydrocortisone administration groups to determine the outcomes of these interventions on blood glucose levels Additionally the infants heels were warmed by soaking in warm water This is no longer the current practice as most institutions use gel heat packs designed specifically for warming the heels of infants
The goal of this study is to simultaneously compare the capillary blood glucose levels from warmed and un-warmed heels in approximately 100 infants who are being breast andor formula fed using the current practice of warming heels with gel heat packs The null hypothesis is that there will be no difference between capillary blood glucose levels sampled from an infants warmed and un-warmed heel It has been proposed that warming the heel will increase blood flow to the capillary bed and improve peripheral blood stasis that may otherwise result in a falsely low glucose reading Therefore the alternative hypothesis is that capillary blood glucose levels sampled from warmed heels will be higher than those samples from un-warmed heels
After admission to the newborn nursery or NICU the infants mother will be approached regarding her participation and of her newborn baby If participation is desired mom will sign consent for herself and for the infant PHI authorization will be obtained Warmed and un-warmed heel capillary blood glucose will be obtained from the infant at the time of a clinically indicated point of care glucose check A heating pad will be placed on one heel for 10 minutes The other heel will not be warmed A lancet will be used to produce blood at both heels and blood glucose will be measured from both heels using the Nova Stat glucometer
Data from the hospitalization will be extracted from the Electronic Health Record from both mother and baby Data will include demographic information medications and health conditions delivery information and anthropometric data Data analysis will be done using SPSS Statistic software to evaluate for differences between capillary blood glucose levels from warmed and unwarmed heels
1 Thompson-Branch A and Havranek T Neonatal Hypoglycemia Pediatr Rev April 2017384147-157 DOI httpsdoiorg101542pir2016-0063
2 Alsaleem M Saadeh L and Kamat D Neonatal Hypoglycemia A Review Clin Pediatr Phila 2019 Nov58131381-1386 doi 1011770009922819875540 Epub 2019 Sep 26
3 Hosagasi NH Aydein M Zenciroglu A Ustun N and Beken S Incidence of hypoglycemia in newborns at risk and an audit of the 2011 American academy of pediatrics guideline for hypoglycemia Pediatr Neonatl 2018 Aug594368-374 doi 101016jpedneo201711009 Epup 2017 Nov 15
4 Alemu BT Beydoun HA Hoch M Van Lunen B and Akpinar-Elci M Hospitalization cost in infants with hypoglycemia Curr Pediatr Res Dec 2018224
5 Rozance PJ and Wolfsdorf JI Hypoglycemia in the Newborn Pediatr Clin North Am Apr 2019662333-342 doi 101016jpcl201812004 Epub 2019 Feb 1
6 Beardsall K Measurement of glucose levels in the newborn Early Hum Dev May 2010865263-267 doi 101016jearlhumdev201005005 Epub 2010 Jun 9
7 Hussain K and Sharief N The inaccuracy of venous and capillary blood glucose measurement using reagent strips in the newborn period and the effect of haematocrit Early Hum Dev 2000 Feb572111-21 doi 101016s0378-37829900060-2
8 Ameur K et al Evaluation of the measurement of capillary glucose concentration versus plasma glucose in the newborn Arch Pediatr 2016 Sep239908-12 doi101016jarcped201604025 Epub 2016 Jun 28
9 Balion C Grey V Ismaila A Blatz S and Seidlitz W Screening for hypoglycemia at the bedside in the neonatal intensive care unit NICU with the Abbott PCx glucose meter BMC Pediatr 2006 Nov 3628 doi 1011861471-2431-6-28
10 Hamid MH Chrishti AL and Maqbool S Clinical utility and accuracy of a blood glucose meter for the detection of neonatal hypoglycemia J Coll Physicians Surg Pak 2004 Apr144225-8
11 Short BL Capillary blood sampling In Fletcher MA MacDonald MG eds Adas of procedures in neonatology Philadelphia J B Lippincott Co 1993 97-100
12 Meites S Skin-puncture and blood-collecting technique for infants update and problems Clin Chem 1988 Sep3491890-4
13 Suichies HE Brouwer C Aarnoudse JG Jentink HW de Mul FFM and Greve J Skin blood flow changes measured by laser doppler flowmetry in the first week after birth Early Hum Devel 1990 23 1-8
14 Takayanagi T Fukunda M Nakazawa M Tanaka S and Yoshinaga M Response of skin blood volume velocity and flow to local warming in newborns measured by laser Doppler flowmetry Pediatr Int 1999 Dec416624-30 doi 101046j1442-200x199901145x
15 Beinder E Trojan A Bucher HU Huch A and Huch R Control of skin blood flow in pre- and full- term infants Biol Neonate 19946517-15 doi 101159000244021
16 Barker DP Willetts B Cappendjik VC and Rutter N Capillary blood sampling should the heel be warmed Arch Dis Child 199674139-40
17 Janes M Pinelli J Landry S Downey S and Paes B Comparison of capillary blood sampling using an automated incision device with and without warming of the heel J Perinatol 200222154-58
18 Russell G and McKay E Blood Glucose Concentration in the Perinatal Period Arch Dis Child 1966 Oct41496-502s0378-37829900060-2
8 Ameur K et al Evaluation of the measurement of capillary glucose concentration versus plasma glucose in the newborn Arch Pediatr 2016 Sep239908-12 doi101016jarcped201604025 Epub 2016 Jun 28
9 Balion C Grey V Ismaila A Blatz S and Seidlitz W Screening for hypoglycemia at the bedside in the neonatal intensive care unit NICU with the Abbott PCx glucose meter BMC Pediatr 2006 Nov 3628 doi 1011861471-2431-6-28
10 Hamid MH Chrishti AL and Maqbool S Clinical utility and accuracy of a blood glucose meter for the detection of neonatal hypoglycemia J Coll Physicians Surg Pak 2004 Apr144225-8
11 Short BL Capillary blood sampling In Fletcher MA MacDonald MG eds Adas of procedures in neonatology Philadelphia J B Lippincott Co 1993 97-100
12 Meites S Skin-puncture and blood-collecting technique for infants update and problems Clin Chem 1988 Sep3491890-4
13 Suichies HE Brouwer C Aarnoudse JG Jentink HW de Mul FFM and Greve J Skin blood flow changes measured by laser doppler flowmetry in the first week after birth Early Hum Devel 1990 23 1-8
14 Takayanagi T Fukunda M Nakazawa M Tanaka S and Yoshinaga M Response of skin blood volume velocity and flow to local warming in newborns measured by laser Doppler flowmetry Pediatr Int 1999 Dec416624-30 doi 101046j1442-200x199901145x
15 Beinder E Trojan A Bucher HU Huch A and Huch R Control of skin blood flow in pre- and full- term infants Biol Neonate 19946517-15 doi 101159000244021
16 Barker DP Willetts B Cappendjik VC and Rutter N Capillary blood sampling should the heel be warmed Arch Dis Child 199674139-40
17 Janes M Pinelli J Landry S Downey S and Paes B Comparison of capillary blood sampling using an automated incision device with and without warming of the heel J Perinatol 200222154-58
18 Russell G and McKay E Blood Glucose Concentration in the Perinatal Period Arch Dis Child 1966 Oct41496-502
Study Oversight
Has Oversight DMC:
None
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?:
None