Hypoglycemia in Newborn InfantsGEHPPINCT04353713
Gel for Early Hypoglycaemia Prevention in Preterm Infants
A study testing 40% Dextrose Gel and 2% carboxymethylcellulose gel in people with Hypoglycemia in Newborn Infants, run by University College Dublin at 5 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 30 minutesHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia in Newborn Infants
- What is being tested?
- 40% Dextrose Gel and 2% carboxymethylcellulose gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 534 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 5 Nov 2020to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 minutes
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The study population will consist of infants born at ≤ 32 weeks gestation. These may include singleton or multiples births.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Ireland4 sites, 4 recruiting
- Recruiting
Rotunda Hospital
Dublin, D01P5W9
Margaret Moran, MB BCh BAO, 01-8730700, mmoran@rotunda.ie
Christine McDermott, MSc RNP, 01-8730700, cmcdermott@rotunda.ie
- Recruiting
The National Maternity Hospital
Dublin, D02YH21
Jyothsna Purna, MBBS MRCPCH, 01- 6373100 ext. 3438, jpurna@nmh.ie
Shirley Moore, MSc, H. Dip, 01-6373100, shirley.moore@nmh.ie
- Recruiting
Coombe Women & Infants University Hospital
Dublin, Dublin 8
John Kelleher, MB BCh MSPH, 353-1-4085200 ext. 5244, jkelleher@coombe.ie
Julie Sloan, 353-1-4085200 ext. 5244, jsloan@coombe.ie
- Recruiting
Galway University Hospital
Galway, XXXXX
Johannes B Letshwiti, MB BCH, 353-91893678, Johannes.letshwiti@hse.ie
Jean James, RM ANP, 353-91893225, jean.james@hse.ie
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Motol
Prague, Praha 5
Jan Janota, PhD, 420-603587632, janjanota@yahoo.com
About this study
Official title: Oral Dextrose Gel to Prevent Early Hypoglycaemia in Very Preterm Infants
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.
Read more
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.
Read the detailed description
Fetal glucose homeostasis in-utero has some very important characteristics: Kalhan et al. showed that from 20 weeks gestation onwards the lower limit for in-utero (foetal) glucose was 3 mmol/L over most of their remaining gestation (Kalhan et al., 1979); Secondly, foetal glucose control in-utero is completely dependent on maternal plasma glucose control and maternal insulin secretion (Stanley et al., 2015); Lastly, steady state glucose utilization rates in term neonates are 4 to 6 mg/min/kg, however at earlier gestational ages (both foetal and preterm infants) these values are higher 8-9 mg/min/kg (Hay, 2006) indicating that preterm infants need an early and reliable glucose source at birth.
A local retrospective audit in our Level 3 Neonatal Unit (King et al., 2018) reviewed 90 patients who were born in-house ≤ 32 weeks gestation with birth weight ≤1500g over 12months in CWIUH (April 2016 - March 2017). Analysis showed that the first blood gas (at the time of first intravenous insertion) was at median 48mins (IQR 15min) life. Data showed that 30 of 90 patients (33.3%) had hypoglycaemia of <1.8 mmol/L at the time of first intravenous access. This hypoglycaemia is at a level below an operational threshold (level at which to intervene) most commonly accepted internationally.
Recommendations from the Pediatric Endocrine Society (2015) are that for high-risk neonates (without a suspected congenital hypoglycaemia disorder), the goal of treatment is to maintain a plasma glucose concentration >2.8 mmol/L for those aged < 48hrs (grade 2+ evidence) (Thornton et al., 2015). However the American Academy of Pediatrics Committee on Fetus and Newborn advise that if asymptomatic, intravenous treatment of hypoglycaemia is not needed until glucose concentrations are < 1.4 mmol/L (within 4hrs after birth) or <2.0 mmol/L (from 4 to 24 h after birth) (Adamkin, 2011). However if symptomatic and blood glucose <2.2 mmol/L they recommend treating immediately (Adamkin, 2011).
Regarding long-term outcomes, in 2006 Boluyt et al. performed the first systematic review of the evidence for neurodevelopmental impairment following hypoglycaemia in the first week of life. They felt that none of the 18 eligible studies identified provided a valid estimate of the effect of neonatal hypoglycaemia on neurodevelopment. The authors provided recommendations about an optimal study design (Boluyt et al., 2006). In 2018 Shah et al. performed a systematic review and meta-analysis which included neonates born ≥32 weeks gestation who had been screened for hypoglycaemia in the 1st week of life. The authors felt that tests of general development in infancy are unlikely to adequately assess the effects of neonatal hypoglycaemia on brain development, but instead future studies will require longer-term end points at least into mid-childhood, including specific tests of visual-motor and executive function (Shah et al., 2018).
Despite the absence of consensus in the medical literature today, this study's investigators feel that tackling the problem of early hypoglycaemia in these very/extremely premature infants will allow a smoother transition from in-utero (foetal) to postnatal (ex-utero) glucose homeostasis. This may have important long-term neurodevelopmental consequences.
Our study aims to tackle this problem of early hypoglycemia in these vulnerable newborns. To do this we will give these newborns a small amount of 40% dextrose gel as early as possible after birth via the buccal route. They will absorb the gel through the small blood vessels located on the inside of their cheeks \& gums and it will enter their bloodstream quickly. We hope this gel will prevent hypoglycemia occurring during the time period needed for the newborns to be transported to the neonatal unit where they will have some form of venous access inserted.
As this research is a trial we want to see if this dextrose gel has this beneficial effect or not. To do this we need to compare the dextrose gel to a non-sugar containing gel (called the "placebo"). The placebo gel will contain simple cellulose ingredient but does not contain sugar and will have no effect on blood glucose. Both gels used in the trial will look identical in appearance and neither the researcher nor the patient (nor parent/s) will know whether they received either the dextrose or the placebo gels. Which gel a newborn receives will be assigned at random, immediately prior to the birth. All newborns will be cared for in the same way according to best standard care.
Newborns will not undergo any additional tests as part of the study. Blood glucose levels will be measured as per standard practice at the time vascular access is obtained. Blood glucose values will be measured on either a blood gas analyzer or laboratory glucose. Patient data collected as part of the study will be pseudo-anonymized/ anonymized and stored safely. Consent for participation can be withdrawn at any time.
- Conditions
- Hypoglycemia in Newborn Infants
- Being tested
- 40% Dextrose Gel, 2% carboxymethylcellulose gel
- Keywords
- Prematurity, oral dextrose gel, randomized controlled trial, placebo
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40% Dextrose GelDietary supplement
Prophylactic administration of 40% dextrose gel via buccal mucosa to prevent newborn hypoglycemia
2% carboxymethylcellulose gelDietary supplement
placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: 2% carboxymethylcellulose gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Any hypoglycemic episode < 2.6 mmol/l (46/mg/dl) within first 24 hours after birth
Measured: 24 hours after birth
Proportion of newborns with a hypoglycaemia episode <1.8mmol/L (32.4 mg/dl) within first 24hrs after birth
Any hypoglycaemia episode <1.8mmol/L (32.4 mg/dl) within first 24hrs after birth
Measured: 24 hours after birth
Number of episodes of hypoglycaemia <2.6mmol/L (46 mg/dl) within first 24hrs after birth
Number of episodes of hypoglycaemia <2.6mmol/L (46 mg/dl) within first 24hrs after birth
Measured: 24 hours after birth
Proportion of newborns with a hyperglycaemia episode > 10 mmol/L (180 mg/dl) within first 24hrs after birth
Proportion of newborns with a hyperglycaemia episode > 10 mmol/L (180 mg/dl) within first 24hrs after birth
Measured: 24 hours after birth
Proportion of newborns who received rescue IV dextrose within first 24hrs after birth
Number of subjects who received rescue IV dextrose (2ml/kg of Dextrose 10%) within first 24hrs after birth
Measured: 24 hours after birth
Tolerance of buccal gel in delivery room
Tolerance of buccal gel (dextrose/placebo): as defined by small/moderate/large spills from the mouth of the newborn
Measured: 30 minutes after birth
Incidence of symptomatic hypoglycaemia
This is defined by a modified Whipples Triad: (1) Presence of characteristic clinical manifestations (tremor, lethargy, coma, seizures) (2) coincident with low plasma glucose concentrations measured accurately with sensitive and precise methods, and (3) that the clinical signs resolve within minutes to hours once normoglycaemia has been re-established.
Measured: 24 hours after birth
Proportion of newborns who died within the first 12 hours after birth
Proportion of newborns who died due to any etiology within the first 12 hours after birth
Measured: 12 hours after birth
Proportion of newborns who died after 12 hours following birth but prior to discharge home
Proportion of newborns who died due to any etiology after 12 hours following birth but prior to discharge home or transfer to another hospital
Measured: 6 months
Incidence of early bacterial sepsis and/or meningitis
Incidence of early bacterial sepsis and/or meningitis. This is defined as a positive bacterial growth in either blood and/or cerebrospinal fluid anytime during first 3 days after birth.
Measured: First 3 days after birth
Incidence of necrotising enterocolitis (NEC).
Incidence of NEC prior to discharge home or transfer to another hospital. NEC will be defined at either surgery, at post-mortem, or clinically and radiographically.
Measured: 6 months
Proportion of newborns with severe retinopathy of prematurity requiring treatment.
Proportion of newborns with severe retinopathy of prematurity requiring treatment. with either Bevacizumab (Avastin) and/or laser therapy. This will be prior to discharge home and/or transfer to another hospital.
Measured: 6 months
Proportion of newborns with severe (grade III/IV) intraventricular-germinal matrix hemorrhage (IVH-GMH).
Proportion of newborns with severe (grade III/IV) intraventricular-germinal matrix hemorrhage (IVH-GMH). This will be based upon any cranial ultrasound performed prior to discharge or transfer to another hospital.
Measured: 6 months
Proportion of newborns with periventricular leukomalacia (PVL).
Proportion of newborns with any degree of PVL. This will be based upon any cranial ultrasound performed prior to discharge or transfer to another hospital.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start5 Nov 2020
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hypoglycemia in Newborn InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 534 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John P Kelleher, MB BCH, Principal investigator, Coombe Women & Infants University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353713
- Sponsor's protocol ID
- 0062019
- Acronym
- GEHPPI
- Status last verified
- Sep 2021
- First submitted
- 16 Dec 2019
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21357346Boluyt 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.
PubMed 16740869Hay 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.
PubMed 16455683Kalhan 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.
PubMed 429559Shah 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.
PubMed 30408811Stanley 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.
PubMed 25819173Thornton 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.
PubMed 25957977King 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.
PubMed 39515988
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Dextrose Gel to Prevent Early Hypoglycaemia in Very Preterm Infants
- ClinicalTrials.gov ID
- NCT04353713
- Acronym / sponsor ID
- GEHPPI / 0062019
- Conditions
- Hypoglycemia in Newborn Infants
- Keywords
- Prematurity, oral dextrose gel, randomized controlled trial, placebo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 534 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fetal glucose homeostasis in-utero has some very important characteristics: Kalhan et al. showed that from 20 weeks gestation onwards the lower limit for in-utero (foetal) glucose was 3 mmol/L over most of their remaining gestation (Kalhan et al., 1979); Secondly, foetal glucose control in-utero is completely dependent on maternal plasma glucose control and maternal insulin secretion (Stanley et al., 2015); Lastly, steady state glucose utilization rates in term neonates are 4 to 6 mg/min/kg, however at earlier gestational ages (both foetal and preterm infants) these values are higher 8-9 mg/min/kg (Hay, 2006) indicating that preterm infants need an early and reliable glucose source at birth.
A local retrospective audit in our Level 3 Neonatal Unit (King et al., 2018) reviewed 90 patients who were born in-house ≤ 32 weeks gestation with birth weight ≤1500g over 12months in CWIUH (April 2016 - March 2017). Analysis showed that the first blood gas (at the time of first intravenous insertion) was at median 48mins (IQR 15min) life. Data showed that 30 of 90 patients (33.3%) had hypoglycaemia of <1.8 mmol/L at the time of first intravenous access. This hypoglycaemia is at a level below an operational threshold (level at which to intervene) most commonly accepted internationally.
Recommendations from the Pediatric Endocrine Society (2015) are that for high-risk neonates (without a suspected congenital hypoglycaemia disorder), the goal of treatment is to maintain a plasma glucose concentration >2.8 mmol/L for those aged < 48hrs (grade 2+ evidence) (Thornton et al., 2015). However the American Academy of Pediatrics Committee on Fetus and Newborn advise that if asymptomatic, intravenous treatment of hypoglycaemia is not needed until glucose concentrations are < 1.4 mmol/L (within 4hrs after birth) or <2.0 mmol/L (from 4 to 24 h after birth) (Adamkin, 2011). However if symptomatic and blood glucose <2.2 mmol/L they recommend treating immediately (Adamkin, 2011).
Regarding long-term outcomes, in 2006 Boluyt et al. performed the first systematic review of the evidence for neurodevelopmental impairment following hypoglycaemia in the first week of life. They felt that none of the 18 eligible studies identified provided a valid estimate of the effect of neonatal hypoglycaemia on neurodevelopment. The authors provided recommendations about an optimal study design (Boluyt et al., 2006). In 2018 Shah et al. performed a systematic review and meta-analysis which included neonates born ≥32 weeks gestation who had been screened for hypoglycaemia in the 1st week of life. The authors felt that tests of general development in infancy are unlikely to adequately assess the effects of neonatal hypoglycaemia on brain development, but instead future studies will require longer-term end points at least into mid-childhood, including specific tests of visual-motor and executive function (Shah et al., 2018).
Despite the absence of consensus in the medical literature today, this study's investigators feel that tackling the problem of early hypoglycaemia in these very/extremely premature infants will allow a smoother transition from in-utero (foetal) to postnatal (ex-utero) glucose homeostasis. This may have important long-term neurodevelopmental consequences.
Our study aims to tackle this problem of early hypoglycemia in these vulnerable newborns. To do this we will give these newborns a small amount of 40% dextrose gel as early as possible after birth via the buccal route. They will absorb the gel through the small blood vessels located on the inside of their cheeks \& gums and it will enter their bloodstream quickly. We hope this gel will prevent hypoglycemia occurring during the time period needed for the newborns to be transported to the neonatal unit where they will have some form of venous access inserted.
As this research is a trial we want to see if this dextrose gel has this beneficial effect or not. To do this we need to compare the dextrose gel to a non-sugar containing gel (called the "placebo"). The placebo gel will contain simple cellulose ingredient but does not contain sugar and will have no effect on blood glucose. Both gels used in the trial will look identical in appearance and neither the researcher nor the patient (nor parent/s) will know whether they received either the dextrose or the placebo gels. Which gel a newborn receives will be assigned at random, immediately prior to the birth. All newborns will be cared for in the same way according to best standard care.
Newborns will not undergo any additional tests as part of the study. Blood glucose levels will be measured as per standard practice at the time vascular access is obtained. Blood glucose values will be measured on either a blood gas analyzer or laboratory glucose. Patient data collected as part of the study will be pseudo-anonymized/ anonymized and stored safely. Consent for participation can be withdrawn at any time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dextrose Gel | Experimental | Dietary Supplement: 40% Dextrose GelDextrose 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. |
| Placebo | Placebo comparator | Dietary Supplement: 2% carboxymethylcellulose gel2% 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. |
Who may qualify
- Ages
- Up to 30 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The study population will consist of infants born at ≤ 32 weeks gestation. These may include singleton or multiples births.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 40% Dextrose GelProphylactic administration of 40% dextrose gel via buccal mucosa to prevent newborn hypoglycemia | Dietary supplement | Dextrose Gel |
| 2% carboxymethylcellulose gelplacebo | Dietary supplement | Placebo |
Primary outcome
Proportion of newborns with initial hypoglycemia after birth
Time frame: 30-60 minutes 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
14 secondary outcomes
Proportion of newborns with a hypoglycaemia episode < 2.6mmol/L (46 mg/dl) within first 24hrs after birth
Time frame: 24 hours after birth
Proportion of newborns with a hypoglycaemia episode <1.8mmol/L (32.4 mg/dl) within first 24hrs after birth
Time frame: 24 hours after birth
Number of episodes of hypoglycaemia <2.6mmol/L (46 mg/dl) within first 24hrs after birth
Time frame: 24 hours after birth
Proportion of newborns with a hyperglycaemia episode > 10 mmol/L (180 mg/dl) within first 24hrs after birth
Time frame: 24 hours after birth
Proportion of newborns who received rescue IV dextrose within first 24hrs after birth
Time frame: 24 hours after birth
Tolerance of buccal gel in delivery room
Time frame: 30 minutes after birth
Incidence of symptomatic hypoglycaemia
Time frame: 24 hours after birth
Proportion of newborns who died within the first 12 hours after birth
Time frame: 12 hours after birth
Proportion of newborns who died after 12 hours following birth but prior to discharge home
Time frame: 6 months
Incidence of early bacterial sepsis and/or meningitis
Time frame: First 3 days after birth
Incidence of necrotising enterocolitis (NEC).
Time frame: 6 months
Proportion of newborns with severe retinopathy of prematurity requiring treatment.
Time frame: 6 months
Proportion of newborns with severe (grade III/IV) intraventricular-germinal matrix hemorrhage (IVH-GMH).
Time frame: 6 months
Proportion of newborns with periventricular leukomalacia (PVL).
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Background: PubMed 21357346Committee 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.
- Background: PubMed 16740869Boluyt 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.
- Background: PubMed 16455683Hay 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.
- Background: PubMed 429559Kalhan 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.
- Background: PubMed 30408811Shah 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.
- Background: PubMed 25819173Stanley 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.
- Background: PubMed 25957977Thornton 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.
- Derived from this study: PubMed 39515988King 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John P Kelleher, MB BCH principal investigator
Coombe Women & Infants University Hospital
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 40% Dextrose Gel and 2% carboxymethylcellulose gel in people with Hypoglycemia in Newborn Infants, run by University College Dublin at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ireland, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John P Kelleher, MB BCH MSPH (353-1-4085200 ext. 5244, jkelleher@coombe.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of newborns with initial hypoglycemia after birth (time frame: 30-60 minutes after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04353713, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.