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Clinical Trials/ACTRN12614001263684
ACTRN12614001263684
Active, not recruiting
Phase 3

In newborn infants at risk of hypoglycaemia does prophylactic oral dextrose gel compared to placebo reduce admission to Newborn Intensive Care Unit (NICU).

niversity of Auckland0 sites2,149 target enrollmentDecember 3, 2014
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Conditionseonatal HypoglycaemiaNeonatal HypoglycaemiaMetabolic and Endocrine - Other metabolic disordersReproductive Health and Childbirth - Complications of newborn

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
eonatal Hypoglycaemia
Sponsor
niversity of Auckland
Enrollment
2149
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 3, 2014
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Babies who are at risk of hypoglycaemia, defined as satisfying AT LEAST ONE of the following:
  • •1\. Infants of diabetic mothers (any type of diabetes)
  • •2\. Preterm (\< 37 weeks' gestation)
  • •3\. Small (\< 2\.5kg or \< 10th centile on population or customised birthweight chart)
  • •4\. Large (\> 4\.5kg or \> 90th centile on population or customised birthweight chart)
  • •AND satisfy ALL of the following:
  • •1\. \> or \= 35\+0 weeks' gestation
  • •2\. Birthweight \> or \= 2\.2kg
  • •3\. \< 1 hour old
  • •4\. No apparent indication for NICU/SCBU admission at time of randomisation

Exclusion Criteria

  • •1\. Major congenital abnormality
  • •2\. Previous formula feed or intravenous fluids
  • •3\. Previous diagnosis of hypoglycaemia
  • •4\. Admitted to NICU/SCBU
  • •5\. Imminent admission to NICU/SCB

Outcomes

Primary Outcomes

Not specified

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