Diazoxide for Severe or Recurrent Neonatal Hypoglycemia: A Randomized Clinical Trial
Primary result · Time to resolution of hypoglycemia (enteral bolus feeding without IV fluids and normoglycemia [47-98 mg/dL] ≥24 h)Result — go to the resultAHR for resolution of hypoglycemia 1.39 95% CI 0.84–2.23Authors' conclusion
In this randomized clinical trial, 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.
Study context
- Population
- Neonates ≥35 weeks' gestation, <1 week of age, with severe hypoglycemia (blood glucose <22 mg/dL or <36 mg/dL despite 2 doses of dextrose gel) or recurrent hypoglycemia (≥3 episodes <47 mg/dL within 48 hours); tertiary neonatal units at 2 New Zealand hospitals, May 2020–February 202374 analysed
- Participants
- 75 neonates
- Comparison
- Early low-dose oral diazoxide vs placebo
- Diazoxiden = 36
- Placebon = 38reference
- Primary endpoint
- Time to resolution of hypoglycemia: enteral bolus feeding without IV fluids and normoglycemia (47-98 mg/dL) for ≥24 hours
Methodological details2-arm, placebo-controlled, 2 centres, Follow-up of at least 2 weeks
- 2-arm
- Placebo-controlled
- 2 centres
- Follow-up of at least 2 weeks
Primary result
As reported in the abstract
Time to resolution of hypoglycemia (enteral bolus feeding without IV fluids and normoglycemia [47-98 mg/dL] ≥24 h)
AHR for resolution of hypoglycemia
1.39
95% CI 0.84–2.23
Diazoxidevs Placebo
aHR for resolution of hypoglycemia 1.39 (95% CI 0.84–2.23)
Secondary outcomes
| Outcome | Estimate | |
|---|---|---|
| Resolution of hypoglycemia redefined post hoc (enteral bolus feeding without IV fluids ≥24 h, no further hypoglycemia)Reached by more newborns with diazoxide · post hoc | aHR for resolution of hypoglycemia (post hoc definition) 2.60 (95% CI 1.53–4.46) | |
| Duration of hypoglycemia | adjusted ratio of geometric means 0.18 (95% CI 0.06–0.53) | |
| Time to enteral bolus feeding | adjusted ratio of geometric means 0.74 (95% CI 0.58–0.95) | |
| Time to weaning from IV fluids | adjusted ratio of geometric means 0.72 (95% CI 0.60–0.87) | |
| 0.050.21520Ratio (log scale) |
Hypoglycemia after the loading dose
| Outcome | Adjusted count ratio (95% CI) |
|---|---|
| Number of blood glucose testsFewer with diazoxide | 0.63 (0.56–0.71) |
| Episodes of hypoglycemiaFewer with diazoxide | 0.32 (0.17–0.63) |
Safety
- Increased episodes of elevated blood glucose concentration and longer time to normoglycemia with diazoxide
Original publication
Diazoxide for Severe or Recurrent Neonatal Hypoglycemia: A Randomized Clinical Trial. JAMA Netw Open. Published 3 June 2024. doi:10.
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