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Gel for Early Hypoglycaemia Prevention in Preterm Infants

NCT04353713 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 534

Last updated 2021-09-30

No results posted yet for this study

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 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.

Conditions

  • Hypoglycemia in Newborn Infants

Interventions

DIETARY_SUPPLEMENT

40% Dextrose Gel

Prophylactic administration of 40% dextrose gel via buccal mucosa to prevent newborn hypoglycemia

DIETARY_SUPPLEMENT

2% carboxymethylcellulose gel

placebo

Sponsors & Collaborators

  • University College Dublin

    lead OTHER

Principal Investigators

  • John P Kelleher, MB BCH · Coombe Women & Infants University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
30 Minutes
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-05
Primary Completion
2022-11-30
Completion
2022-12-31

Countries

  • Czechia
  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04353713 on ClinicalTrials.gov