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Meta-Analysis
. 2023 Nov 28;11(11):CD012152.
doi: 10.1002/14651858.CD012152.pub4.

Oral dextrose gel to prevent hypoglycaemia in at-risk neonates

Lily Roberts  1 , Luling Lin  1 , Jane Alsweiler  2   3 , Taygen Edwards  1 , Gordon Liu  1 , Jane E Harding  1
Affiliations
Meta-Analysis

Oral dextrose gel to prevent hypoglycaemia in at-risk neonates

Lily Roberts et al. Cochrane Database Syst Rev. .

Abstract

Background: Neonatal hypoglycaemia is a common condition that can be associated with brain injury. Current practice usually includes early identification of at-risk infants (e.g. infants of diabetic mothers; preterm, small- or large-for-gestational-age infants), and prophylactic measures are advised. However, these measures often involve use of formula milk or admission to the neonatal unit. Dextrose gel is non-invasive, inexpensive and effective for treatment of neonatal hypoglycaemia. Prophylactic dextrose gel can reduce the incidence of neonatal hypoglycaemia, thus potentially reducing separation of mother and baby and supporting breastfeeding, as well as preventing brain injury. This is an update of a previous Cochrane Review published in 2021.

Objectives: To assess the effectiveness and safety of oral dextrose gel in preventing hypoglycaemia before first hospital discharge and reducing long-term neurodevelopmental impairment in newborn infants at risk of hypoglycaemia.

Search methods: We searched CENTRAL, MEDLINE, Embase and Epistemonikos in April 2023. We also searched clinical trials databases and the reference lists of retrieved articles.

Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs comparing oral dextrose gel versus placebo, no intervention, or other therapies for the prevention of neonatal hypoglycaemia. We included newborn infants at risk of hypoglycaemia, including infants of mothers with diabetes (all types), high or low birthweight, and born preterm (< 37 weeks), age from birth to 24 hours, who had not yet been diagnosed with hypoglycaemia.

Data collection and analysis: Two review authors independently extracted data and assessed the risk of bias. We contacted investigators to obtain additional information. We used fixed-effect meta-analyses. We used the GRADE approach to assess the certainty of evidence.

Main results: We included two studies conducted in high-income countries comparing oral dextrose gel versus placebo in 2548 infants at risk of neonatal hypoglycaemia. Both of these studies were included in the previous version of this review, but new follow-up data were available for both. We judged these two studies to be at low risk of bias in 13/14 domains, and that the evidence for most outcomes was of moderate certainty. Meta-analysis of the two studies showed that oral dextrose gel reduces the risk of hypoglycaemia (risk ratio (RR) 0.87, 95% confidence interval (CI) 0.79 to 0.95; risk difference (RD) -0.06, 95% CI -0.10 to -0.02; 2548 infants; high-certainty evidence). Evidence from two studies showed that there may be little to no difference in the risk of major neurological disability at two years of age after oral dextrose gel (RR 1.00, 95% CI 0.59 to 1.68; 1554 children; low-certainty evidence). Meta-analysis of the two studies showed that oral dextrose gel probably reduces the risk of receipt of treatment for hypoglycaemia during initial hospital stay (RR 0.89, 95% CI 0.79 to 1.00; 2548 infants; moderate-certainty evidence) but probably makes little or no difference to the risk of receipt of intravenous treatment for hypoglycaemia (RR 1.01, 0.68 to 1.49; 2548 infants; moderate-certainty evidence). Oral dextrose gel may have little or no effect on the risk of separation from the mother for treatment of hypoglycaemia (RR 1.12, 95% CI 0.81 to 1.55; two studies, 2548 infants; low-certainty evidence). There is probably little or no difference in the risk of adverse effects in infants who receive oral dextrose gel compared to placebo gel (RR 1.22, 95% CI 0.64 to 2.33; two studies, 2510 infants; moderate-certainty evidence), but there are no studies comparing oral dextrose with other comparators such as no intervention or other therapies. No data were available on exclusive breastfeeding after discharge.

Authors' conclusions: Prophylactic oral dextrose gel reduces the risk of neonatal hypoglycaemia in at-risk infants and probably reduces the risk of treatment for hypoglycaemia without adverse effects. It may make little to no difference to the risk of major neurological disability at two years, but the confidence intervals include the possibility of substantial benefit or harm. Evidence at six to seven years is limited to a single small study. In view of its limited short-term benefits, prophylactic oral dextrose gel should not be incorporated into routine practice until additional information is available about the balance of risks and harms for later neurological disability. Additional large follow-up studies at two years of age or older are required. Future research should also be undertaken in other high-income countries, low- and middle-income countries, preterm infants, using other dextrose gel preparations, and using comparators other than placebo gel. There are three studies awaiting classification and one ongoing study which may alter the conclusions of the review when published.

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Conflict of interest statement

LR has no interest to declare. She was an independent reviewer who extracted data and assessed bias and certainty of evidence for both included studies.

LL has no interest to declare. She was an independent reviewer who extracted data and assessed bias and certainty of evidence for both included studies.

JA is an author of the included studies (Harding 2021; Hegarty 2016a). She has published opinions in medical journals relevant to the interventions in the work. The studies were funded by Auckland Medical Research Foundation and Health Research Council of New Zealand.

TE is an author of an included study (Harding 2021). The study was funded by Health Research Council of New Zealand (HRC) (grant 15/216) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH; grant R01HD091075).

GL has no interest to declare.

JH is an author of the included studies (Harding 2021; Hegarty 2016a). She is the principal investigator of the pre‐hPOD trial and follow‐up studies, funded from: A+ Trust (A+5696); Auckland Medical Research Foundation (1113012); Cure Kids (3537, 3561); Lottery Health Research (241266, 326844); philanthropic donations to the University of Auckland Foundation (F‐ILG‐LRSR); Health Research Council of New Zealand (15/216, 19/690); Gravida, National Centre for Growth and Development (SCH‐14‐14 Hegarty); and Eunice Kennedy Shriver National Institute of Child Health & Human Development, National Institutes of Health (R01HD091075). She is also the principal investigator of the hPOD trial and follow‐up studies, funded from: Health Research Council of New Zealand (13/131, 15/216), Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health (R01HD091075). She received partial salary support for research with results included in this review and during the writing of this review from Eunice Kennedy Shriver National Institute of Child Health and Human Development. She has given multiple lectures and published some review articles which relate to the material included in this review, none directly reporting the contents of the review.

Figures

1
1
Study flow diagram
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
1.1
1.1. Analysis
Comparison 1: Dextrose gel versus control, Outcome 1: Hypoglycaemia
1.2
1.2. Analysis
Comparison 1: Dextrose gel versus control, Outcome 2: Major neurological disability at two years of age
1.3
1.3. Analysis
Comparison 1: Dextrose gel versus control, Outcome 3: Major neurological disability at six to seven years of age
1.4
1.4. Analysis
Comparison 1: Dextrose gel versus control, Outcome 4: Major neurological disability at two years of age ‐ by risk factor
1.5
1.5. Analysis
Comparison 1: Dextrose gel versus control, Outcome 5: Receipt of treatment for hypoglycaemia during initial hospital stay
1.6
1.6. Analysis
Comparison 1: Dextrose gel versus control, Outcome 6: Separation from mother for treatment of hypoglycaemia (admission to NICU for hypoglycaemia)
1.7
1.7. Analysis
Comparison 1: Dextrose gel versus control, Outcome 7: Receipt of intravenous treatment for hypoglycaemia
1.8
1.8. Analysis
Comparison 1: Dextrose gel versus control, Outcome 8: Adverse effects (e.g. choking or vomiting at time of administration)
1.9
1.9. Analysis
Comparison 1: Dextrose gel versus control, Outcome 9: Developmental disability at two years of age
1.10
1.10. Analysis
Comparison 1: Dextrose gel versus control, Outcome 10: Developmental disability at six to seven years of age
1.11
1.11. Analysis
Comparison 1: Dextrose gel versus control, Outcome 11: Any neurological disability at two years of age ‐ by risk factor
1.12
1.12. Analysis
Comparison 1: Dextrose gel versus control, Outcome 12: Any neurological disability at six to seven years of age ‐ by risk factor
1.13
1.13. Analysis
Comparison 1: Dextrose gel versus control, Outcome 13: Any neurological disability at six to seven years of age ‐ by single or multiple gel dose
1.14
1.14. Analysis
Comparison 1: Dextrose gel versus control, Outcome 14: Receipt of oral dextrose gel treatment for hypoglycaemia
1.15
1.15. Analysis
Comparison 1: Dextrose gel versus control, Outcome 15: Receipt of any medications for hypoglycaemia such as glucagon or corticosteroids
1.16
1.16. Analysis
Comparison 1: Dextrose gel versus control, Outcome 16: Number of episodes of hypoglycaemia (glucose oxidase method) (total number per infant)
1.17
1.17. Analysis
Comparison 1: Dextrose gel versus control, Outcome 17: Neonatal seizures
1.18
1.18. Analysis
Comparison 1: Dextrose gel versus control, Outcome 18: Duration of initial hospital stay (days)
1.19
1.19. Analysis
Comparison 1: Dextrose gel versus control, Outcome 19: Breastfeeding (any) after discharge
1.20
1.20. Analysis
Comparison 1: Dextrose gel versus control, Outcome 20: Visual impairment at two years of age
1.21
1.21. Analysis
Comparison 1: Dextrose gel versus control, Outcome 21: Hearing impairment at two years of age
1.22
1.22. Analysis
Comparison 1: Dextrose gel versus control, Outcome 22: Cerebral palsy at two years of age
1.23
1.23. Analysis
Comparison 1: Dextrose gel versus control, Outcome 23: Developmental delay/intellectual impairment at two years of age
1.24
1.24. Analysis
Comparison 1: Dextrose gel versus control, Outcome 24: Developmental delay/intellectual impairment at two years of age ‐ mild (70 to 84)
1.25
1.25. Analysis
Comparison 1: Dextrose gel versus control, Outcome 25: Developmental delay/intellectual impairment at two years of age ‐ moderate or severe (< 70)
1.26
1.26. Analysis
Comparison 1: Dextrose gel versus control, Outcome 26: Developmental delay/intellectual impairment at six to seven years of age
1.27
1.27. Analysis
Comparison 1: Dextrose gel versus control, Outcome 27: Developmental delay/intellectual impairment at two years of age ‐ by risk factor
1.28
1.28. Analysis
Comparison 1: Dextrose gel versus control, Outcome 28: Executive dysfunction at two years of age
1.29
1.29. Analysis
Comparison 1: Dextrose gel versus control, Outcome 29: Executive dysfunction at six to seven years of age
1.30
1.30. Analysis
Comparison 1: Dextrose gel versus control, Outcome 30: Executive dysfunction at six to seven years of age ‐ by single or multiple gel dose
1.31
1.31. Analysis
Comparison 1: Dextrose gel versus control, Outcome 31: Executive dysfunction at two years of age ‐ by risk factor
1.32
1.32. Analysis
Comparison 1: Dextrose gel versus control, Outcome 32: Executive dysfunction at six to seven years of age ‐ by risk factor
1.33
1.33. Analysis
Comparison 1: Dextrose gel versus control, Outcome 33: Emotional‐behavioural difficulty at six to seven years of age
1.34
1.34. Analysis
Comparison 1: Dextrose gel versus control, Outcome 34: Emotional‐behavioural difficulty at six to seven years of age ‐ by risk factor
1.35
1.35. Analysis
Comparison 1: Dextrose gel versus control, Outcome 35: Emotional‐behavioural difficulty at six to seven years of age ‐ by single or multiple gel dose
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References

References to studies included in this review

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