What are the best options for oral treatment of neonatal hypoglycemia?

Comment by InpharmD Researcher

For oral management of neonatal hypoglycemia, clinical literature describe use of 40% oral glucose gel, diazoxide, and nifedipine, though collated data in general are limited and conflicting. While most other objectives were inconclusive, data suggests oral glucose gel may be effective in preventing neonatal hypoglycemia when compared to placebo.

Background

The 2011 United States (US) Committee on Fetus and Newborn guideline was released prior to the commercial availability of oral dextrose gel and so did not address their use for neonatal hypoglycemia, recommending intravenous glucose feeds instead. [1]

Subsequently, the 2019 Canadian Paediatric Society recommended dextrose 40% gel administered intrabuccal at 0.5 mL/kg for neonatal hypoglycemia as an alternative to IV therapy for asymptomatic infants with blood glucose <2.6 mmol/L in conjunction with enteral supplementation. However, this was recommended as a temporary measure in symptomatic infants until dextrose infusions could be started. [2]

In the Harris et al. Sugar Babies trial, dextrose gel was observed to have less treatment failures (success defined as blood glucose levels > 2.6 mmol/L after one/two dose) versus placebo (14% vs 24%; relative risk [RR] 0.57; 95% CI 0.33 to 0.98; p=0.04). Reduced neonatal admissions and supplementations needed from formulas were also observed for dextrose gels. It is recommended to administer with breastfeeding or formula. The 0.5 mg/kg dose should provide approximately 200 mg/kg of glucose which is equivalent to an IV bolus dose of 2 mL/kg of a D10W solution. [2], [3]

In 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) provided an extensive review of the efficacy of dextrose gel in neonatal hypoglycemia. Limited evidence gathered from the acquired systematic reviews found either beneficial or conflicting evidence in preventing neonatal hypoglycemia in at-risk patients. The data shows lack of evidence in reducing admission to neonatal ICU or special care, and adverse events seem to be similar versus placebo. [4]

Subsequent systematic reviews and meta-analyses have further confirmed the significant reduction in NICU admissions for symptomatic hypoglycemia with dextrose oral gel administration.

A Cochrane review evaluated the effects of dextrose gel in treating neonatal hypoglycemia. This analysis encompassed data from multiple randomized controlled trials, focusing on both the efficacy and safety profile of dextrose gel compared to placebo or no treatment at all. The primary outcome of interest was the normalization of blood glucose levels within a specified timeframe after gel administration. Secondary outcomes included neurodevelopmental implications at follow-up periods, ranging from infancy to early childhood. The studies collectively involved a diverse cohort of neonates, ensuring a robust representation of the target population. The findings highlighted a statistically significant improvement in glucose stabilization among neonates treated with dextrose gel compared to the control groups. The preferred formulation was oral dextrose gel (specifically 40% dextrose concentration) administered buccally. With regards to rates of adverse neurodevelopmental outcomes, there was no significant increase, suggesting a favorable safety profile for the gel's use in clinical practice. Importantly, these results underscore the potential of dextrose gel as a first-line intervention for managing neonatal hypoglycemia in at-risk late preterm and term infants, offering a straightforward application with minimal complications. [5]

A 2013 review examined the management strategies for neonatal hypoglycemia, particularly focusing on both transient and persistent forms. The review explored available therapeutic options such as dextrose infusions, glucagon, glucocorticoids, diazoxide, octreotide, and nifedipine. In general, there is a lack of a universally accepted threshold in defining neonatal hypoglycemia, though the authors suggest management of glucose levels under 50 mg/dL as hypoglycemic. Various treatments were discussed, such as the use of dextrose infusions to maintain euglycemia, especially in cases of hyperinsulinism, with glucagon and glucocorticoids recommended for acute management. Of the treatment options, diazoxide was highlighted as the first-line for hyperinsulinemic hypoglycemia and one of two available therapies which are available for oral use, though its efficacy is limited by genetic factors influencing insulin secretion. Octreotide was discussed as a secondary option, particularly if diazoxide fails, while oral nifedipine was noted as an investigational choice due to limited published data (see Table 1). [6]

A 2023 review conducted a thorough comparison of the most recent guidelines from major medical societies regarding the diagnosis and management of neonatal hypoglycemia (NH). This descriptive review scrutinized and synthesized recommendations from six influential organizations: the American Academy of Pediatrics (AAP), the British Association of Perinatal Medicine (BAPM), the European Foundation for the Care of the Newborn Infants (EFCNI), the Queensland Clinical Guidelines-Australia (AUS), the Canadian Pediatric Society (CPS), and the Pediatric Endocrine Society (PES). The analysis highlighted a significant consensus on the risk factors, clinical signs, and symptoms of NH, as well as the importance of early recognition and prompt treatment initiation to optimize outcomes. All organizations, except for the PES, recommended screening for NH in both asymptomatic high-risk and symptomatic newborns, though noted inconsistencies in screening approaches and operational thresholds for management, cut-off values, and treatment strategies. The review noted discrepancies among guidelines in defining NH, operational thresholds for intervention, and managing symptomatic and asymptomatic hypoglycemic neonates. Although the guidelines universally acknowledged the critical importance of preventing NH to avert potential brain injury and neurodevelopmental impairment, they differed in their definitions of NH and the cut-off glucose values warranting intervention. The AAP, AUS, and CPS identify a blood glucose level of less than 2.6 mmol/L (47 mg/dL) as a key operational threshold in the first 72 hours, while BAPM proposes a more conservative approach with different cut-off levels during the initial postnatal period. In asymptomatic NH, BAPM, EFCNI, and CPS recommend buccal administration of dextrose gel 40% at a dose of 200 mg/kg. [7]

A 2025 systematic review and meta-analysis examined the effectiveness of oral dextrose gel for managing neonatal hypoglycemia. This analysis synthesized data from five randomized controlled trials involving a total of 2,742 neonates, where 1,326 received oral dextrose gel and 1,416 were given a placebo. The primary focus was on reducing NICU admissions for neonates with blood glucose levels below 2.6 mmol/L. Initial findings from the meta-analysis indicated a non-significant reduction in NICU admissions (risk ratio 0.68; 95% confidence interval [CI] 0.33 to 1.38; p= 0.28). However, a sensitivity analysis excluding one outlier study revealed consistent and statistically significant results, showing a reduction in NICU admissions (risk ratio 0.52; 95% CI 0.31 to 0.90; p= 0.02), despite remaining substantial heterogeneity among studies. Despite variations across included trials, the evidence supports the potential clinical utility of oral dextrose gel to effectively manage neonatal hypoglycemia and reduce NICU admissions, presenting it as a valuable non-invasive alternative to intravenous interventions. [8]

References: [1] Committee on Fetus and Newborn. Postnatal glucose homeostasis in late-preterm and term infants. PEDIATRICS. 2011;127(3):575-579.
[2] Narvey MR, Marks SD. The screening and management of newborns at risk for low blood glucose. Paediatrics & Child Health. 2019;24(8):536-544.
[3] Harris DL, Weston PJ, Signal M, Chase JG, Harding JE. Dextrose gel for neonatal hypoglycaemia (the Sugar Babies Study): A randomised, double-blind, placebocontrolled trial. Lancet 2013 21;382(9910):2077–83.
[4] Palylyk-Colwell E, Campbell K. Oral Glucose Gel for Neonatal Hypoglycemia: A Review of Clinical Effectiveness, Cost-Effectiveness and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2018 Jul 4. Available from: https://www.ncbi.nlm.nih.gov/books/NBK537952/
[5] Edwards T, Liu G, Battin M, et al. Oral dextrose gel for the treatment of hypoglycaemia in newborn infants. Cochrane Database Syst Rev. 2022;3(3):CD011027. Published 2022 Mar 18. doi:10.1002/14651858.CD011027.pub3
[6] Sweet CB, Grayson S, Polak M. Management strategies for neonatal hypoglycemia. J Pediatr Pharmacol Ther. 2013;18(3):199-208. doi:10.5863/1551-6776-18.3.199
[7] Giouleka S, Gkiouleka M, Tsakiridis I, et al. Diagnosis and Management of Neonatal Hypoglycemia: A Comprehensive Review of Guidelines. Children (Basel). 2023;10(7):1220. Published 2023 Jul 14. doi:10.3390/children10071220
[8] Sivakumar G, Kuppusamy P, P LP, Mishra A, Sivakumar S. Effectiveness of oral dextrose gel for neonates at risk of hypoglycemia: A systematic review, meta-analysis, and GRADE assessment of randomized controlled trials. J Perinatol. 2025;45(10):1335-1344. doi:10.1038/s41372-025-02387-x
Literature Review

A search of the published medical literature revealed 6 studies investigating the researchable question:

What are the best options for oral treatment of neonatal hypoglycemia?

Level of evidence

B - One high-quality study or multiple studies with limitations  Read more→



Please see Tables 1-6 for your response.


Pharmacologic Agents for Treatment of Neonatal Hypoglycemia
Agent Dosing Administration Side Effects*
Dextrose 4-8 mg/kg/min
(max: 20-30 mg/kg/min)
Continuous infusion -
Diazoxide 10-15 mg/kg/day Orally (once every 8 hr) Hirsutism, heart failure, fluid retention, nausea, vomiting
Glucagon Bolus: 200 mcg/kg
1 mg/day
Intermittent infusion
Continuous infusion
Hyponatremia, thrombocytopenia
Glucocorticoids     Growth suppression, hypertension
Dexamethasone 0.25 m/kg
1-2.5 mg/kg/dose
Intravenous (once every 12 hr)
Intravenous (once every 6 hr)
Hydrocortisone 50 mg/m2/day -
Nifedipine Initial: 0.25-0.3 mg/kg/day
Final: 0.5-0.8 mg/kg/day
Orally (once every 8 hr) None reported
Octreotide 7-12 mcg/kg/day
(max: 40 mcg/kg/day)
Subcutaneous (every 4-6 hr)
May be given continuously IV
Cholelithiasis
* Adverse events listed are not all inclusive. Those reported have been described in patients receiving these agents for the treatment of hypoglycemia

 

References:
[1] [1] Adapted from: Sweet CB, Grayson S, Polak M. Management strategies for neonatal hypoglycemia. J Pediatr Pharmacol Ther. 2013;18(3):199-208. doi:10.5863/1551-6776-18.3.199
Dextrose gel for neonatal hypoglycaemia (the Sugar Babies Study): a randomised, double-blind, placebo-controlled trial
Design

Randomised, double-blind, placebo-controlled trial

N= 237

Objective To assess whether treatment with dextrose gel was more effective than feeding alone for reversal of neonatal hypoglycaemia in at-risk babies
Study Groups

40% Dextrose gel (n= 118)

Placebo gel (n= 119)

Inclusion Criteria Babies aged 35-42 weeks’ gestation, younger than 48-h-old, and at risk of hypoglycaemia, including infants of diabetic mothers, preterm (35 or 36 weeks’ gestation), small or large birthweight, or poor feeding
Exclusion Criteria Previous treatment for neonatal hypoglycaemia, serious congenital malformation, terminal disorders, or skin abnormalities preventing use of continuous glucose monitor
Methods Babies were randomly assigned to receive 40% dextrose gel 200 mg/kg or placebo gel. The gel was massaged into the buccal mucosa, and blood glucose was measured 30 minutes after administration. Up to six doses could be given over 48 hours. Continuous glucose monitoring was used for some participants.
Duration December 1, 2008, to November 31, 2010
Outcome Measures

Primary: Treatment failure (blood glucose <2.6 mmol/L after two treatment attempts)

Secondary: Admission to neonatal intensive-care unit, frequency of breastfeeding, volume and frequency of expressed breastmilk and infant formula, incidence of rebound and recurrent hypoglycaemia, time to achieve glucose concentrations ≥2.6 mmol/L, duration of low glucose concentrations

Baseline Characteristics   Dextrose gel (n= 118) Placebo gel (n= 119)
Boys 48 (41%) 65 (55%)
Birthweight, g 3091 (824) 3031 (782)
Gestation, week 37.4 (1.6) 37.2 (1.6)
Blood glucose concentration at time of randomization, mmol/L 2.2(1.1-2.5) 2.2(0.9-2.5)
Results   Dextrose gel (n= 118) Placebo gel (n= 119) p-value
Treatment failure 16 (14%) 29 (24%) 0.04

Admitted to NICU

Babies

For hypoglycaemia

 

45 (38%)

16 (14%)

 

55 (46%)

30 (25%)

 

0.24

0.03

Adverse Events No serious adverse events reported. Three babies in the placebo group had one blood glucose concentration of 0.9 mmol/L. No other adverse events occurred.
Study Author Conclusions Treatment with dextrose gel is more effective than feeding alone for reversing neonatal hypoglycaemia in at-risk late preterm and term babies. It reduces the need for NICU admission for hypoglycaemia and supports breastfeeding without increasing adverse effects.
Critique The study's strengths include its randomised, double-blind, placebo-controlled design and the use of continuous glucose monitoring. Limitations include the potential for selection bias due to the specific inclusion criteria and the inability to generalize findings to all neonatal populations. The study did not explore the ideal dosing of dextrose gel or its efficacy in different gestational ages.

 

References:
[1] [1] Harris DL, Weston PJ, Signal M, Chase JG, Harding JE. Dextrose gel for neonatal hypoglycaemia (the Sugar Babies Study): a randomised, double-blind, placebo-controlled trial. Lancet. 2013;382(9910):2077-2083. doi:10.1016/S0140-6736(13)61645-1

 

Dextrose gel for neonates at risk with asymptomatic hypoglycemia: a randomized clinical trial

Design

Open-label, parallel design, randomized controlled trial in a Level 3B tertiary neonatal care unit in South India

N= 291

Objective

To study the efficacy of 40% oral dextrose gel along with breastfeeding for treating asymptomatic hypoglycemia over breast feeding alone in reducing neonatal ICU (NICU) admissions for intravenous treatment

Study Groups

Intervention (dextrose 40% gel followed by breastfeeding; n= 147)

Control (breastfeeding only; n= 144)

Inclusion Criteria

Neonates born ≥35 weeks gestation determined to be at-risk for hypoglycemia (as stratified by prespecified gestational age and body weight categories); small for gestational age (SGA) and intrauterine growth restriction (IUGR); infant of a diabetic mother (IDM) and large for gestational age (LGA); late preterm (≥35 weeks gestation); developed hypoglycemia in the first 48 hours of life

Exclusion Criteria

Babies who required resuscitation efforts at birth; need for intravenous fluid therapy; NICU admission for any other reason within first 48 hours of life

Methods

Informed consent provided by mothers of eligible neonates either prior to delivery or following delivery. If a neonate had >1 risk factor for at-risk status, that neonate was stratified in the following order: SGA and IUGR, IDM and LGA, and late preterms. Capillary blood glucose (CBG) measured by bedside glucometer and was checked starting at 1 hour of life and then every 3 hours until 48 hours of life. If hypoglycemia was present by 48 hours of life, CBG monitoring continued until 2 consecutive values were ≥60 mg/dL. Hypoglycemia was defined based on the 2011 American Association of Pediatrics guidelines for 3 time periods: 0 to 4 hours of life, 4 to 24 hours of life, and 24 to 48 hours of life.

For intervention group, dextrose 40% gel was slowly placed into the buccal cavity, followed by breastfeeding. Dextrose 40% was prepared as 200 mg/kg (0.5 mL/kg) in a 5 mL oral syringe. CBG was rechecked after 30 minutes, and up to 2 consecutive attempts were allowed for an episode of asymptomatic hypoglycemia. Dextrose gel could be repeated a max of 6 times through the first 48 hours of life. For the control group, breastfeeding was provided with CBG check after 30 minutes. 

Successful treatment was defined as blood glucose >45 mg/dL within 30 minutes of the first or second attempt at correction. Rebound hypoglycemia was defined as any hypoglycemia (CBG <45 mg/dL) within 6 hours after successful treatment. Treatment failure was defined was need for IV fluids for blood glucose regulation after 30 minutes of the second attempt with either intervention or control. If symptomatic hypoglycemia developed at any point in any patient, a 2 mL/kg IV bolus of dextrose 10% was administered at a glucose infusion rate of 6-8 mg/kg/minute.

Duration

Study period from October 2017 to January 2019

Outcome Measures

Primary outcome: Rate of treatment failure

Secondary outcomes: proportion of neonates discharged from hospital on exclusive breastfeeding; adverse effects (including rebound hypoglycemia)

Baseline Characteristics

 

Dextrose 40% oral gel (n= 147)

Breastfeeding alone (n= 144)

 

Mean maternal age, years

29.2 ± 4.56 29.5 ± 5.13  

Primigravida, n (%)

69 (46%) 80 (55%)  

Pregnancy-induced hypertension, n (%)

31 (21.1%) 35 (24.3%)  

Gestational diabetes mellitus, n (%)

68 (46.3%) 70 (48.6%)  

Mean birth weight, grams

2802 ± 618 2728 ± 573  

Male sex in neonate, n (%)

77 (52.4%) 76 (52.8%)  

Need for resuscitation, n (%)

9 (6.2%) 8 (4.6%)  

Late preterm babies >35 weeks, n (%)

55 (37.4%) 62 (43.0%)  

Small for gestational age and intrauterine growth restriction, n (%)

56 (38%) 55 (38.1%)  

Infant of diabetic mother, n (%)

68 (46.3%) 70 (48.6%)  

Median capillary blood glucose, mg/dL

0 to 4 hours

4-24 hours

24-48 hours

 

22 (IQR 21 to 24)

29.8 (IQR 27.5 to 31)

36 (IQR 32.2 to 39.8)

 

22.3 (IQR 21 to 24.8)

32.5 (IQR 26.5 to 34.2)

37.5 (IQR 32 to 34)

 

Results

Endpoint

Dextrose 40% oral gel  (n= 147)

Breastfeeding alone  (n= 144)

p-value

Total number of failures, n (%)

SGA/IUGR

IDM/LGA

Late preterm

17 (11.5%)

6 (12.2%)

7 (13.4%)

4 (8.6%)

58 (40.2%)

20 (41.6%)

20 (43.4%)

18 (36%)

<0.001

<0.001

<0.001

<0.001

Treatment failures requiring IV fluids significantly higher in control group than dextrose group (36.9% vs 9.1%, p< 0.001)

Also significantly higher in the SGA/IUGR subgroup (45.3% control vs 15% dextrose, p< 0.001)

Discharge on exclusive breastfeeding higher in dextrose group than control group but not significant (RR 1.06, 95% CI 0.98 to 1.15)

Adverse Events

No neonate developed adverse effects with dextrose 40% gel, including rebound hypoglycemia. No neonate developed symptomatic hypoglycemia during the study.

Study Author Conclusions

Dextrose gel reduces the need for intravenous fluids in at-risk neonates with asymptomatic hypoglycemia in the first 48 hours of life.

InpharmD Researcher Critique

Dextrose 40% oral gel in neonates at-risk for hypoglycemia reduced the need for NICU admissions due to symptomatic hypoglycemia during the first 48 hours of life. This study was limited by its small sample size given the wide enrollment period. Use of continuous blood glucose monitoring vs CBG can aid in more accurate, real-time measurements of blood glucose trends.



References:
[1] Gupta K, Amboiram P, Balakrishnan U, C A, Abiramalatha T, Devi U. Dextrose Gel for Neonates at Risk With Asymptomatic Hypoglycemia: A Randomized Clinical Trial. Pediatrics. 2022;149(6):e2021050733.

 

Diazoxide for Severe or Recurrent Neonatal Hypoglycemia: A Randomized Clinical Trial

Design

Two-arm, placebo-controlled randomized clinical trial

N= 74

Objective

To evaluate whether early, low-dose oral diazoxide for severe or recurrent neonatal hypoglycemia reduces time to resolution of hypoglycemia. 

Study Groups

Diazoxide group (n= 36)

Placebo group (n= 38)

Inclusion Criteria

Neonates born at 35 or more weeks’ gestation and less than 1 week of age with severe hypoglycemia (blood glucose concentration <22 mg/dL or <36 mg/dL despite 2 doses of dextrose gel) or recurrent hypoglycemia (≥3 episodes of a blood glucose concentration <47 mg/dL within 48 hours). 

Exclusion Criteria

Major congenital malformations, suspected genetic or chromosomal disorders, confirmed sepsis, hypoxic-ischemic encephalopathy, or family history of congenital hyperinsulinism. 

Methods

Newborns were randomized 1:1 to receive diazoxide suspension (loading dose, 5 mg/kg; maintenance, 1.5 mg/kg every 12 hours) or placebo, titrated per protocol. The primary outcome was time to resolution of hypoglycemia, defined as enteral bolus feeding without intravenous fluids and normoglycemia for at least 24 hours. Secondary outcomes included number of blood glucose tests, episodes of hypoglycemia, and duration of hypoglycemia. Newborns were followed up for at least 2 weeks.

Duration

May 2020 to February 2023

Outcome Measures

Primary: Time to resolution of hypoglycemia

Secondary: Number of blood glucose tests, episodes of hypoglycemia, duration of hypoglycemia, time to enteral bolus feeding and weaning from intravenous fluids

Baseline Characteristics

 

Diazoxide group

Placebo

Gestational age, mean (SD), weeks

 37.9 (1.6)  37.4 (1.5)

Male 

26 (72%)   27 (71%)

Recurrent hypoglycemia

24 (65%)   17 (45%)

Severe hypoglycemia

 9 (24%)  12 (32%)

Profound hypglycemia

12 (33%) 19 (50%)

Indian ethnicity

 3 (8%) 6 (16%)

European New Zealander ethnicity

5 (14%) 5 (13%)

Results

Endpoint

Diazoxide group

Placebo group 

Adjusted effect size (95% CI)

Time to achieve normoglycemia, median (IQR), days

1.96 (1.14-2.87)   1.16 (1.04-1.93) 1.29 (1.00-1.67)

Time to establish enteral bolus feeding, median (IQR), days

 1.75 (1.00-2.43)  2.11 (1.58-3.15) 0.74 (0.58-0.95)

Episodes of hypoglycemia, median (IQR), No.

0 (0-0) 1 (0-2) 0.32 (0.17-0.63)

Blood glucose tests, median IQR, No.

11 (9-13) 18 (13-21) 0.63 (0.56-0.71)

Adverse Events

No significant adverse events related to diazoxide were reported. One newborn in the diazoxide group had a seizure unrelated to the trial. No cases of congestive heart failure, pulmonary hypertension, or necrotizing enterocolitis were observed.

Study Author Conclusions

Early treatment of severe or recurrent neonatal hypoglycemia with low-dose oral diazoxide did not reduce time to resolution of hypoglycemia but reduced time to enteral bolus feeding and weaning from intravenous fluids, duration of hypoglycemia, and frequency of blood glucose testing compared with placebo.

InpharmD Researcher Critique

The study was well-designed with effective blinding and practical formulation of diazoxide. However, the modest sample size and short observation period after intervention discontinuation may limit the detection of smaller clinical differences and infrequent outcomes. The high use of formula could have obscured potential benefits of breastfeeding.



References:
[1] [1] Laing D, Walsh EPG, Alsweiler JM, et al. Diazoxide for Severe or Recurrent Neonatal Hypoglycemia: A Randomized Clinical Trial. JAMA Netw Open. 2024;7(6):e2415764. Published 2024 Jun 3. doi:10.1001/jamanetworkopen.2024.15764.
Neonatal hypoglycemia: glucose gel efficacy in the treatment of early hypoglycemia in newborns with risk factors. Randomized clinical trial
Design

Randomized clinical trial, non-inferiority

N= 241

Objective To evaluate the efficacy of 40% glucose gel compared with formula milk in the treatment of early asymptomatic hypoglycemia in newborns with risk factors
Study Groups

40% glucose gel (n= 118)

Infant formula (n= 123)

Inclusion Criteria Term NB (37 to 41 weeks 6/7 days: child of a diabetic mother treated with insulin or oral hypoglycemic agents; small for gestational age (SGA: < P10) and large for gestational age (LGA: > P90) according to Argentine population references; late preterm NB (35 to 36 weeks 6/7 days)
Exclusion Criteria Newborns admitted to neonatal care units, newborns with oral mucosal disorders that prevented the gel administration, newborns with clinical signs compatible with hypoglycemia or glycemia less than 25 mg/dL, confirmed by serum determination, and refusal of their parents to participate in the study
Methods Newborns were randomized to receive either 40% glucose gel 0.5 ml/kg in the oral mucosa or infant formula 9 ml/kg by syringe suction. Glycemic measurements were taken at two hours of life, with treatment administered if hypoglycemia was detected. Successive measurements were taken at one hour in case of hypoglycemia or every 2 hours if normal. Failure was defined as persistent hypoglycemia after two treatments.
Duration July 10, 2017, to June 30, 2020 (36 months)
Outcome Measures

Primary: Correction of hypoglycemia

Secondary: Hospitalization rates, breastfeeding maintenance

Baseline Characteristics   40% Glucose gel (n= 107) Infant formula (n= 115)
Sex - Male 50 (22.5%) 59 (26.6%)
Risk factors - SGA 23 26
Risk factors - LGA 63 65
Risk factors - Infant of diabetic mother 6 4
Risk factors - Late preterm 15 20
Birth weight (grams) 3399.28 3440.93
Gestational age (weeks) - 35 1 (0.5%) 0
Gestational age (weeks) - 36 14 (6.3%) 20 (9%)
Gestational age (weeks) - 37 10 (4.5%) 14 (6.3%)
Gestational age (weeks) - 38 32 (14.4%) 36 (16.2%)
Gestational age (weeks) - 39 26 (11.7%) 32 (14.4%)
Gestational age (weeks) - 40 22 (9.9%) 12 (5.4%)
Gestational age (weeks) - 41 2 (0.9%) 1 (0.5%)
Results   40% Glucose gel (n= 107) Infant formula (n= 115) p-value
Responded to treatment 76 (71%) 104 (90.4%) <0.001
Hospitalized 3/31 2/11 NS
Adverse Events No adverse events reported
Study Author Conclusions The administration of 40% glucose gel was not equivalent to the administration of formula milk in the treatment of early asymptomatic hypoglycemia in newborns with risk factors.
Critique The study was well-designed as a randomized clinical trial, providing a robust comparison between glucose gel and formula milk. However, the study was discontinued early due to the significant difference in efficacy, which may limit the generalizability of the findings. Additionally, the study did not explore long-term outcomes of the treatments, and the sample size was smaller than initially planned due to early termination.

 

References:
[1] [1] Del Carmen Covas M, Quintana D, Oviedo B, et al. Hipoglucemia neonatal: eficacia de la glucosa gel en el tratamiento de la hipoglucemia precoz en recin nacidos con factores de riesgo. Ensayo clnico aleatorizado [Neonatal hypoglycemia: glucose gel efficacy in the treatment of early hypoglycemia in newborns with risk factors. Randomized clinical trial]. Andes Pediatr. 2023;94(1):70-77. doi:10.32641/andespediatr.v94i1.4220
Evaluation of Oral Dextrose Gel for Prevention of Neonatal Hypoglycemia (hPOD): A Multicenter, Double-blind Randomized Controlled Trial
Design

Multicenter, double-blind, placebo-controlled randomized trial

N= 2,149

Objective To assess whether prophylactic dextrose gel given to babies at risk of neonatal hypoglycemia reduces admission to NICU
Study Groups

Dextrose gel (n= 1,070)

Placebo gel (n= 1,063)

Inclusion Criteria Babies born at risk of hypoglycemia (preterm <37 weeks, infant of a mother with diabetes, small or large birthweight) without indications for NICU admission, born at ≥35 weeks' gestation, birthweight ≥2.2 kg, <1 hour old, and mother intended to breastfeed
Exclusion Criteria Major congenital abnormality, received formula feed or intravenous fluids, admitted to NICU, or imminent NICU admission
Methods Babies at risk of neonatal hypoglycemia (maternal diabetes, late preterm, or high or low birthweight) without indications for neonatal intensive care unit (NICU) admission were randomized to 0.5
ml/kg buccal 40% dextrose or placebo gel at 1 hour of age. Blood glucose was measured at 2 hours and then according to hospital practice. 
Duration January 2015 to May 2019
Outcome Measures

Primary: NICU admission

Secondary: Hypoglycemia, NICU admission for hypoglycemia, hyperglycemia, breastfeeding at discharge, formula feeding at 6 weeks, maternal satisfaction

Baseline Characteristics   Placebo (n= 1,063) Dextrose (n= 1,070)
Maternal age (years) 32.2 (5.4) 32.2 (5.3)
Gestational age (weeks) 38.5 (1.1) 38.4 (1.1)
Birthweight (g) 3,313 (594) 3,328 (613)
Girls 523 (49.2%) 515 (48.1%)

Primary reason for risk of hypoglycemia

Infant of mother with diabetes

Preterm (<37 weeks’ gestation)

Small (<2.5 kg or <10th centile)

Large (>4.5 kg or >90th centile)

 

 856 (80.5%)

76 (7.2%)

84 (7.9%)

47 (4.4%)

 

 863 (80.7%)

75 (7.0%)

83 (7.8%)

49 (4.6%)

Results   Placebo (n= 1,063) Dextrose (n= 1,070) aRR or aMD 95% CI p-Value
NICU admission 100 (9.4%) 111 (10.4%) 1.10 0.86, 1.42 0.44
Hypoglycemia 448 (42.1%) 399 (37.3%) 0.88 0.80, 0.98 0.02
NICU admission for hypoglycemia 48 (4.5%) 65 (6.1%) 1.35 0.94, 1.94 0.10
Breastfeeding at hospital discharge 1,010 (95.9%) 1,027 (96.6%) 1.00 0.99, 1.02 0.67
Formula feeding at 6 weeks 473(49.4%) 481(49%) 1.01 0.93, 1.10 0.81
Adverse Events No adverse effects attributable to dextrose gel. Two deaths in each group, not related to the intervention. No hyperglycemia reported.
Study Author Conclusions A single dose of 200 mg/kg prophylactic dextrose gel does not reduce NICU admission in babies at risk. However, it does reduce the incidence of hypoglycemia, with a number needed to treat of 21 (95% confidence interval 11 to 141). Since prophylaxis also appears to be safe and is likely to be cost-effective clinicians and clinical guideline groups should consider whether introduction into clinical practice is warranted at this time.
Critique The study was well-designed with a large sample size and robust methodology. However, the high proportion of infants of mothers with diabetes may limit generalizability. The use of a less reliable glucose analyzer in some cases could affect results. The study did not find a reduction in NICU admissions, which was the primary outcome, but did show a reduction in hypoglycemia, suggesting potential benefits that require further investigation.
References:
[1] [1] Harding JE, Hegarty JE, Crowther CA, et al. Evaluation of oral dextrose gel for prevention of neonatal hypoglycemia (hPOD): A multicenter, double-blind randomized controlled trial. PLoS Med. 2021;18(1):e1003411. Published 2021 Jan 28. doi:10.1371/journal.pmed.1003411