Continuous Glucose Monitoring in HIE

NCT06563687 | Recruiting

• 1 other identifier: SecondUNI84
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of the study is to examine whether the use of continuous glucose monitoring (CGM) to guide the clinical management of glycaemic control will result into an increased time in the target glucose concentration. To further examine the efficacy of using CGM the following secondary outcomes in the two groups were assessed: mean glucose values, glucose variability within individuals, percentage of time that glucose values are in hyperglycaemic or hypoglycaemic ranges. Randomized controlled trial recruiting neonates (Birth weight \>1.8kg, Gestation\>36 weeks) with moderate or severe hypoxic ischemic encephalopathy (HIE) following perinatal asphyxia . Neonates will be randomly assigned (1:1) within 6 hours of birth to receive either the intervention with real-time CGM or standard care for 72 hours.

Conditions

Hypoxic Ischemic Encephalopathy of Newborn; Hyperglycemia; Hypoglycemia

Keywords

Continuous glucose monitoring; Neonatal hypoglycemia; Neonatal hyperglycemia

Outcome Measures

Primary Outcomes (1)

• In range - time

  Proportion of time that the sensor glucose values are in the target range (50 to 180 mg/dL) compared between the study groups

  72 hours after birth

Secondary Outcomes (4)

• Hypoglycemia

  72 hours after birth

• Hyperglycemia

  72 hours after birth

• Glycemic variability

  72 hours after birth

• Adverse events associated to insertion of CGM

  up to 10 days after birth

Study Arms (2)

Experimental: Unblinded CGM

EXPERIMENTAL

CGM data will be "unblinded", with alarms on for hypo and hyperglycemia. CGM data will be used to support clinical management including blood glucose measurements and decision making. Changes in glucose and insulin infusion will be based primarily on the real-time CGM data but blood glucose concentrations will be checked in case of rapid changes in CGM data or before any treatment.

Device: Dexcom ONE+

Blinded CGM

OTHER

CGM data will be blinded. Alarms for Hypo and hyperglycemia will be off. Glucose control will be monitored and managed according to standard clinical practice using intermittently sampled blood glucose concentrations.

Device: Dexcom ONE+

Interventions

Dexcom ONE+ DEVICE

In all the neonates recruited CGM sensor and transmitter will be placed soon after study enrollment. The sensors will be inserted in the lateral thigh and continuous measurements will be recorded for all the duration of therapeutic hypothermia.

Blinded CGM; Experimental: Unblinded CGM

Eligibility Criteria

• Age: Up to 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight \>1.8kg
• Gestation \>35 weeks
• Aged \<6hours
• Moderate or severe HIE following perinatal asphyxia

You may not qualify if:

• Major congenital malformations
• Inborn errors of metabolism,
• Congenital infections
• Imminent death

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (3)

A.O.S.G. Moscati

Avellino, 83100, Italy

NOT YET RECRUITING

Monaldi | | AORN - Ospedali dei ColliAORN - Ospedali dei Colli

Naples, 80131, Italy

NOT YET RECRUITING

University of Campania Luigi Vanvitelli

Napoli, 80100, Italy

RECRUITING

Related Publications (9)

• Kalogeropoulou MS, Thomson L, Beardsall K. Continuous glucose monitoring during therapeutic hypothermia for hypoxic ischaemic encephalopathy: a feasibility study. Arch Dis Child Fetal Neonatal Ed. 2023 May;108(3):309-315. doi: 10.1136/archdischild-2022-324593. Epub 2022 Dec 20.

  PMID: 36600516 BACKGROUND

• Pinchefsky EF, Hahn CD, Kamino D, Chau V, Brant R, Moore AM, Tam EWY. Hyperglycemia and Glucose Variability Are Associated with Worse Brain Function and Seizures in Neonatal Encephalopathy: A Prospective Cohort Study. J Pediatr. 2019 Jun;209:23-32. doi: 10.1016/j.jpeds.2019.02.027. Epub 2019 Apr 11.

  PMID: 30982528 BACKGROUND

• Montaldo P, Caredda E, Pugliese U, Zanfardino A, Delehaye C, Inserra E, Capozzi L, Chello G, Capristo C, Miraglia Del Giudice E, Iafusco D. Continuous glucose monitoring profile during therapeutic hypothermia in encephalopathic infants with unfavorable outcome. Pediatr Res. 2020 Aug;88(2):218-224. doi: 10.1038/s41390-020-0827-4. Epub 2020 Mar 2.

  PMID: 32120381 BACKGROUND

• Mietzsch U, Wood TR, Wu TW, Natarajan N, Glass HC, Gonzalez FF, Mayock DE, Comstock BA, Heagerty PJ, Juul SE, Wu YW; HEAL Study Group. Early Glycemic State and Outcomes of Neonates With Hypoxic-Ischemic Encephalopathy. Pediatrics. 2023 Oct 1;152(4):e2022060965. doi: 10.1542/peds.2022-060965.

  PMID: 37655394 BACKGROUND

• Parmentier CEJ, de Vries LS, van der Aa NE, Eijsermans MJC, Harteman JC, Lequin MH, Swanenburg de Veye HFN, Koopman-Esseboom C, Groenendaal F. Hypoglycemia in Infants with Hypoxic-Ischemic Encephalopathy Is Associated with Additional Brain Injury and Worse Neurodevelopmental Outcome. J Pediatr. 2022 Jun;245:30-38.e1. doi: 10.1016/j.jpeds.2022.01.051. Epub 2022 Feb 2.

  PMID: 35120986 BACKGROUND

• Basu SK, Kaiser JR, Guffey D, Minard CG, Guillet R, Gunn AJ; CoolCap Study Group. Hypoglycaemia and hyperglycaemia are associated with unfavourable outcome in infants with hypoxic ischaemic encephalopathy: a post hoc analysis of the CoolCap Study. Arch Dis Child Fetal Neonatal Ed. 2016 Mar;101(2):F149-55. doi: 10.1136/archdischild-2015-308733. Epub 2015 Aug 17.

  PMID: 26283669 BACKGROUND

• Tam EWY, Kamino D, Shatil AS, Chau V, Moore AM, Brant R, Widjaja E. Hyperglycemia associated with acute brain injury in neonatal encephalopathy. Neuroimage Clin. 2021;32:102835. doi: 10.1016/j.nicl.2021.102835. Epub 2021 Sep 28.

  PMID: 34601311 BACKGROUND

• Puzone S, Diplomatico M, Caredda E, Maietta A, Miraglia Del Giudice E, Montaldo P. Hypoglycaemia and hyperglycaemia in neonatal encephalopathy: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2023 Dec 15;109(1):18-25. doi: 10.1136/archdischild-2023-325592.

  PMID: 37316160 BACKGROUND

• Kamino D, Widjaja E, Brant R, Ly LG, Mamak E, Chau V, Moore AM, Williams T, Tam EWY. Severity and duration of dysglycemia and brain injury among patients with neonatal encephalopathy. EClinicalMedicine. 2023 Mar 23;58:101914. doi: 10.1016/j.eclinm.2023.101914. eCollection 2023 Apr.

  PMID: 37181414 BACKGROUND

MeSH Terms

Conditions

Hyperglycemia; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Paolo Montaldo, PhD

CONTACT

0815664023; paolo.montaldo@unicampania.it

Simona Puzone, MD

CONTACT

simona.puzone@unicampania.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 21, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available 1 to 2 years after the end of the study.
• Access Criteria: Unidentified data will be shared by publication. Request for data that affects patient confidentiality will review by the study PI on a case-by-case basis.

Locations

IT (3)