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Delivery room dextrose gel for preterm hypoglycaemia (the GEHPPI study): a randomised placebo-controlled trial
G. King, J. Sloan, P. Duddy, A. O'Sullivan, N. Ó Catháin, J. Miletin, S. Dempsey, S. Moore, JR. Purna, C. McDermott, M. Moran, J. James, JB. Letshwiti, K. Tabery, A. Kubátová, J. Janota, J. Kelleher
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články, randomizované kontrolované studie
NLK
ProQuest Central
od 1997-01-01 do Před 6 měsíci
Health & Medicine (ProQuest)
od 1997-01-01 do Před 6 měsíci
- MeSH
- aplikace bukální MeSH
- gely MeSH
- gestační stáří MeSH
- glukosa * aplikace a dávkování MeSH
- hypoglykemie * farmakoterapie prevence a kontrola MeSH
- jednotky intenzivní péče o novorozence MeSH
- krevní glukóza analýza MeSH
- lidé MeSH
- nemoci nedonošenců * farmakoterapie MeSH
- novorozenec nedonošený MeSH
- novorozenec MeSH
- porodní sály MeSH
- sladidla aplikace a dávkování MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- novorozenec MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
OBJECTIVE: Early hypoglycaemia at the time of neonatal intensive care unit (NICU) admission is common in very/extreme preterm infants. This study aimed to determine whether buccal dextrose gel in the delivery room (DR) would improve rates of early hypoglycaemia in this population. DESIGN: Randomised, blinded, placebo-controlled trial. SETTING: Four level-3 and one level-2 neonatal units. PATIENTS: Inborn infants≤32+0 weeks gestational age (GA). INTERVENTIONS: Infants were randomised to 40% dextrose or placebo gel in the DR (≤29+0 GA: 0.5 mL gel, ≥29+1 GA: 1 mL gel). MAIN OUTCOME MEASURE: Hypoglycaemia (<1.8 mmol/L) measured at the time of first intravenous access at NICU admission. RESULTS: Between November 2020 and August 2022, the recruitment rate was slow (impacted by the requirement for antenatal consent). This fact, coupled with finite research resources, led to a decision to end recruitment early. Data analysis of 169 newborns (33% of target sample size) showed no significant difference in the frequency of the primary outcome between dextrose 24/84 (29%) and placebo 25/85 (29%) groups (OR 0.95; 95% CI 0.49 to 1.86; p=0.88). A post-hoc analysis indicated that the trial had a low (47% conditional power) chance of detecting a statistically significant benefit from the intervention (had the target sample been achieved). CONCLUSIONS: This study showed no evidence of benefit of 40% dextrose gel on rates of hypoglycaemia at NICU admission. Management of these vulnerable newborns should continue to focus on vascular access and commencement of dextrose-containing intravenous fluids as early as possible. TRIAL REGISTRATION NUMBER: NCT04353713.
Department of Neonatology University Hospital Galway Galway Ireland
Neonatology Department Motol University Hospital Prague Czech Republic
Neonatology Department Rotunda Hospital Dublin Ireland
Neonatology Department The National Maternity Hospital Dublin Ireland
Paediatrics and Newborn Medicine The Coombe Hospital Dublin Ireland
Citace poskytuje Crossref.org
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