NCT04353713|UnknownDMC
Gel for Early Hypoglycaemia Prevention in Preterm Infants
GEHPPI
Oral Dextrose Gel to Prevent Early Hypoglycaemia in Very Preterm Infants
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GEHPPI
Oral Dextrose Gel to Prevent Early Hypoglycaemia in Very Preterm Infants
Sponsor study identifier
interventional
534
2 countries
5
Study Start
November 5, 2020
Actual (reported)Primary Completion
November 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The GEHPPI study is a multicentre placebo controlled randomized controlled trial that aims to prevent early hypoglycaemia in preterm newborns born at ≤32 week's gestation. To do this we will prophylactically administer to these newborns either a small amount of dextrose 40% gel early as possible after birth via the buccal route in the delivery room or a placebo. We hope this dextrose gel will prevent hypoglycemia occurring during the time period needed for the newborns to be transported to the neonatal unit where they will have their venous access inserted. This trial aims to demonstrate that administering dextrose gel via the buccal route is a simple and rapid method of preventing early hypoglycaemia in this vulnerable patient group. This trial aims to show that giving dextrose gel via the buccal route is simple and feasible in this premature population. This trial aims to reduce the need for rescue intravenous dextrose (2ml/kg dextrose 10%) in those babies who are hypoglycaemic at the time of obtaining intravenous access.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 16, 2019
Actual (reported)April 20, 2020
Actual (reported)November 5, 2020
Actual (reported)November 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Proportion of newborns with initial hypoglycemia after birth
Proportion of newborns with an initial plasma glucose value below the operational threshold (\<1.8 mmol/L) (32.4 mg/dl)(measured on blood gas machine or laboratory sample) at a time-point when initial intravascular access is successfully obtained by the clinical team
30-60 minutes after birth
Proportion of newborns with a hypoglycaemia episode < 2.6mmol/L (46 mg/dl) within first 24hrs after birth
24 hours after birth
Proportion of newborns with a hypoglycaemia episode <1.8mmol/L (32.4 mg/dl) within first 24hrs after birth
24 hours after birth
Number of episodes of hypoglycaemia <2.6mmol/L (46 mg/dl) within first 24hrs after birth
24 hours after birth
Proportion of newborns with a hyperglycaemia episode > 10 mmol/L (180 mg/dl) within first 24hrs after birth
24 hours after birth
Proportion of newborns who received rescue IV dextrose within first 24hrs after birth
24 hours after birth
Dextrose 40% gel will be given immediately following stabilization at birth via massage into the buccal membrane. This will be prior to transport from the Delivery Room to the Neonatal Unit. A dose of 1 ml of gel (Dextrose) will be administered to infants born greater than or equal to 29+1 weeks gestation. Prior to administration, a single brief oral suction will be given if required. Half the dose of gel (0.5 ml) will be squeezed onto the gloved finger of a person. This half dose will be given on one side of mouth. The remaining half dose (0.5 ml) of gel will be administered to the other side of the mouth. A total dose of 0.5 ml of gel (Dextrose) will be administered to infants born less than or equal to 29+0 weeks gestation. Half the dose of gel (0.25 ml) will be squeezed onto the gloved finger of administering person. This half dose will be given on one side of mouth. The remaining half dose (0.25 ml) of gel will be administered to the other side of the mouth.
2% carboxymethylcellulose gel will be given following stabilization at birth via buccal route. This will be prior to in-house transport from the Delivery Room to the Neonatal Unit. A standard total dose of 1 ml of placebo gel will be administered to infants born greater than or equal to 29+1 weeks gestation. Prior to administration, a single brief oral suction will be given if required. Half the dose of gel (0.5 ml) will be squeezed onto the gloved finger of person. This half dose will be given on one side of mouth. The remaining half dose (0.5 ml) of gel will be administered to the other side of the mouth. A total dose of 0.5 ml of gel (Placebo) will be administered to infants born less than or equal to 29+0 weeks gestation. Half the dose of gel (0.25 ml) will be squeezed onto the gloved finger of a person. This half dose will be given on one side of mouth. The remaining half dose (0.25 ml) of gel will be administered to the other side of the mouth.
Prophylactic administration of 40% dextrose gel via buccal mucosa to prevent newborn hypoglycemia
placebo
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Hospital Motol
Prague, Praha 5, Czechia
Rotunda Hospital
Dublin, D01P5W9, Ireland
Committee on Fetus and Newborn; Adamkin DH. Postnatal glucose homeostasis in late-preterm and term infants. Pediatrics. 2011 Mar;127(3):575-9. doi: 10.1542/peds.2010-3851. Epub 2011 Feb 28.
Boluyt N, van Kempen A, Offringa M. Neurodevelopment after neonatal hypoglycemia: a systematic review and design of an optimal future study. Pediatrics. 2006 Jun;117(6):2231-43. doi: 10.1542/peds.2005-1919.
John P Kelleher, MB BCH
Coombe Women & Infants University Hospital
First Submitted
December 16, 2019
First Posted
Contact the study team to confirm eligibility.
The National Maternity Hospital
Dublin, D02YH21, Ireland
Coombe Women & Infants University Hospital
Dublin, Dublin 8, Ireland
Galway University Hospital
Galway, XXXXX, Ireland
Hay WW Jr. Recent observations on the regulation of fetal metabolism by glucose. J Physiol. 2006 Apr 1;572(Pt 1):17-24. doi: 10.1113/jphysiol.2006.105072. Epub 2006 Feb 2.
Kalhan SC, D'Angelo LJ, Savin SM, Adam PA. Glucose production in pregnant women at term gestation. Sources of glucose for human fetus. J Clin Invest. 1979 Mar;63(3):388-94. doi: 10.1172/JCI109314.
Shah R, Harding J, Brown J, McKinlay C. Neonatal Glycaemia and Neurodevelopmental Outcomes: A Systematic Review and Meta-Analysis. Neonatology. 2019;115(2):116-126. doi: 10.1159/000492859. Epub 2018 Nov 8.
Stanley CA, Rozance PJ, Thornton PS, De Leon DD, Harris D, Haymond MW, Hussain K, Levitsky LL, Murad MH, Simmons RA, Sperling MA, Weinstein DA, White NH, Wolfsdorf JI. Re-evaluating "transitional neonatal hypoglycemia": mechanism and implications for management. J Pediatr. 2015 Jun;166(6):1520-5.e1. doi: 10.1016/j.jpeds.2015.02.045. Epub 2015 Mar 25. No abstract available.
Thornton PS, Stanley CA, De Leon DD, Harris D, Haymond MW, Hussain K, Levitsky LL, Murad MH, Rozance PJ, Simmons RA, Sperling MA, Weinstein DA, White NH, Wolfsdorf JI; Pediatric Endocrine Society. Recommendations from the Pediatric Endocrine Society for Evaluation and Management of Persistent Hypoglycemia in Neonates, Infants, and Children. J Pediatr. 2015 Aug;167(2):238-45. doi: 10.1016/j.jpeds.2015.03.057. Epub 2015 May 6. No abstract available.
King G, Sloan J, Duddy P, O'Sullivan A, O Cathain N, Miletin J, Dempsey S, Moore S, Purna JR, McDermott C, Moran M, James J, Letshwiti JB, Tabery K, Kubatova A, Janota J, Kelleher J. Delivery room dextrose gel for preterm hypoglycaemia (the GEHPPI study): a randomised placebo-controlled trial. Arch Dis Child Fetal Neonatal Ed. 2025 Apr 17;110(3):319-325. doi: 10.1136/archdischild-2024-327313.
April 20, 2020
Study Start
November 5, 2020
Actual (reported)Primary Completion
November 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 30, 2021
Record last verified: 2021-09
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