Status:
UNKNOWN
Gel for Early Hypoglycaemia Prevention in Preterm Infants
Lead Sponsor:
University College Dublin
Conditions:
Hypoglycemia in Newborn Infants
Eligibility:
All Genders
Up to 30 years
Phase:
NA
Brief 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 prophylac...
Detailed Description
Fetal glucose homeostasis in-utero has some very important characteristics: Kalhan et al. showed that from 20 weeks gestation onwards the lower limit for in-utero (foetal) glucose was 3 mmol/L over mo...
Eligibility Criteria
Inclusion
- The study population will consist of infants born at ≤ 32 weeks gestation. These may include singleton or multiples births.
Exclusion
- Any newborn where comfort care (palliative approach) is planned for the care of the newborn following delivery. This will often be due to an antenatally diagnosed lethal and/or major congenital anomaly.
Key Trial Info
Start Date :
November 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
534 Patients enrolled
Trial Details
Trial ID
NCT04353713
Start Date
November 5 2020
End Date
December 1 2022
Last Update
September 30 2021
Active Locations (5)
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1
University Hospital Motol
Prague, Czechia, Praha 5
2
Rotunda Hospital
Dublin, Ireland, D01P5W9
3
The National Maternity Hospital
Dublin, Ireland, D02YH21
4
Coombe Women & Infants University Hospital
Dublin, Ireland, Dublin 8