Gel for Early Hypoglycaemia Prevention in Preterm Infants

NCT04353713 | Unknown DMC

• 1 other identifier: 0062019
• Study Type: interventional
• Target: 534
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Hypoglycemia in Newborn Infants

Keywords

Prematurity; oral dextrose gel; randomized controlled trial; placebo

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• 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

Study Arms (2)

Dextrose Gel

EXPERIMENTAL

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.

Dietary Supplement: 40% Dextrose Gel

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: 2% carboxymethylcellulose gel

Interventions

40% Dextrose Gel DIETARY_SUPPLEMENT

Prophylactic administration of 40% dextrose gel via buccal mucosa to prevent newborn hypoglycemia

Dextrose Gel

2% carboxymethylcellulose gel DIETARY_SUPPLEMENT

placebo

Placebo

Eligibility Criteria

• Age: Up to 30 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The study population will consist of infants born at ≤ 32 weeks gestation. These may include singleton or multiples births.

You may not qualify if:

• Any newborn where comfort care (palliative approach) is planned for the care of the newborn following delivery. This will often be due to an antenatally diagnosed lethal and/or major congenital anomaly.

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (5)

University Hospital Motol

Prague, Praha 5, Czechia

RECRUITING

Rotunda Hospital

Dublin, D01P5W9, Ireland

RECRUITING

The National Maternity Hospital

Dublin, D02YH21, Ireland

RECRUITING

Coombe Women & Infants University Hospital

Dublin, Dublin 8, Ireland

RECRUITING

Galway University Hospital

Galway, XXXXX, Ireland

RECRUITING

Related Publications (8)

• 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.

  PMID: 21357346 BACKGROUND

• 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.

  PMID: 16740869 BACKGROUND

• 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.

  PMID: 16455683 BACKGROUND

• 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.

  PMID: 429559 BACKGROUND

• 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.

  PMID: 30408811 BACKGROUND

• 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.

  PMID: 25819173 BACKGROUND

• 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.

  PMID: 25957977 BACKGROUND

• 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.

  PMID: 39515988 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• John P Kelleher, MB BCH

  Coombe Women & Infants University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John P Kelleher, MB BCH MSPH

CONTACT

353-1-4085200; jkelleher@coombe.ie

Julie Sloan

CONTACT

353-1-4085200; jsloan@coombe.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The intervention in this study will consist of oral administration of either Dextrose 40% gel or placebo (2% carboxymethylcellulose) gel immediately after stabilisation of the preterm infant in the delivery room.These intervention products will be identically labelled pre-filled syringes. No person involved in either the trial or clinical care of the newborn will ever know the identity of whether dextrose gel or placebo was ever administered to the newborn.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a randomised, double-blinded (using masking), placebo controlled clinical trial. It will involve multiple study sites. The study population will consist of infants born at ≤32 weeks gestation. These may include singleton or multiples births. Randomisation will be stratified into two groups using gestational age at birth: ≤29 weeks 29+1 to ≤32 weeks Randomisation will also be stratified by multi-centre site.

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: April 20, 2020
• Study Start: November 5, 2020
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); IE (4)