NCT02583776

Brief Summary

Neonatal hypoglycemia is associated with brain injury and impaired neurodevelopment outcomes in very low birth weight infants (VLBWI). Glycemic monitoring is usually performed by capillary or central line sampling but does not identify up to 81% of hypoglycemic episodes in preterm newborns. The investigators aim to assess if a continuous glucose monitor (CGM) can be used to maintain euglycemia (defined as a target value 72-144mg/dl) in VLBWI. It will be enrolled newborns ≤32 weeks gestational age and/or of birthweight ≤1500 g, within 48 hours of life, they will be randomized in two study arms, both them will wear Dexcom G4 Platinum CGM: 1) Unblinded group (UB): glucose daily intake will be modulated according to CGM (Dexcom G4 Platinum) during the first 7 days of life, alarms for hypos/hyper will be active; 2) Blinded group (B), glucose infusion rate will be modified according to 2-3 daily capillary glucose tests, alarms for hypos will be switched off. Pain at insertion will be evaluated with the validated Premature Infant Pain Profile (PIPP) scale. The estimated numerosity is 50 patients (25 for each arm).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_4

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

6 months

First QC Date

October 19, 2015

Last Update Submit

August 9, 2016

Conditions

Infant, Very Low Birth WeightNeonatal Hypoglycemia

Keywords

continuous glucose monitoring (cgm)neonatal hypoglycemiavery low birth weight infants (VLBWI)preterm infants

Outcome Measures

Primary Outcomes (1)

  • In range - time

    Percentage of time in range 72-144mg/dl

    7 days (minimum 2)

Secondary Outcomes (6)

  • Hypoglycemia

    7days

  • Acute event associated to glycemic variability and/or hypoglycemia

    7days

  • Glycemic variability and hypoglycemia predictors

    7days

  • hypoglycemia prediction

    7days

  • Glycemic modeling

    7days

  • +1 more secondary outcomes

Study Arms (2)

Unblinded CGM

EXPERIMENTAL

CGM data will be "unblinded", with Hypo/hyperglycemia alarms on. Data will be recorded from CGM every three hours and intervention to adequate glucose intake will be performed to keep glycemia in normal range (72-144mg/dl) if necessary.

Device: Unblinded - CGM

Blinded CGM

OTHER

Hypo/hyper alarms are off. CGM data will be blinded. Glucose intake will be adequate according to 2-3 capillary glycemic tests per day.

Device: Blinded - CGM

Interventions

Unblinded - CGMDEVICE

Data from device will be readable and alarms on

Unblinded CGM
Blinded - CGMDEVICE

Data from device will be blinded and alarms off

Blinded CGM

Eligibility Criteria

Age2 Hours - 2 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \<= 32 weeks gestation
  • birthweight \<1500 g

You may not qualify if:

  • birthweight \<500g
  • malformative syndrome
  • lack of parental consent
  • chromosomal abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Boston Children's Hospital

Boston, Massachusetts, MA02215, United States

Location

Neonatal Intensive Care Unit - University Hospital of Padua

Padua, Padua, 35128, Italy

Location

Department of Information Engineering - University of Padua

Padua, Padua, 35131, Italy

Location

Related Publications (14)

  • Agus MS, Steil GM, Wypij D, Costello JM, Laussen PC, Langer M, Alexander JL, Scoppettuolo LA, Pigula FA, Charpie JR, Ohye RG, Gaies MG; SPECS Study Investigators. Tight glycemic control versus standard care after pediatric cardiac surgery. N Engl J Med. 2012 Sep 27;367(13):1208-19. doi: 10.1056/NEJMoa1206044. Epub 2012 Sep 7.

    PMID: 22957521RESULT

  • Beardsall K, Vanhaesebrouck S, Ogilvy-Stuart AL, Vanhole C, Palmer CR, Ong K, vanWeissenbruch M, Midgley P, Thompson M, Thio M, Cornette L, Ossuetta I, Iglesias I, Theyskens C, de Jong M, Gill B, Ahluwalia JS, de Zegher F, Dunger DB. Prevalence and determinants of hyperglycemia in very low birth weight infants: cohort analyses of the NIRTURE study. J Pediatr. 2010 Nov;157(5):715-9.e1-3. doi: 10.1016/j.jpeds.2010.04.032. Epub 2010 Jun 8.

    PMID: 20570286RESULT

  • Beardsall K, Vanhaesebrouck S, Ogilvy-Stuart AL, Vanhole C, Palmer CR, van Weissenbruch M, Midgley P, Thompson M, Thio M, Cornette L, Ossuetta I, Iglesias I, Theyskens C, de Jong M, Ahluwalia JS, de Zegher F, Dunger DB. Early insulin therapy in very-low-birth-weight infants. N Engl J Med. 2008 Oct 30;359(18):1873-84. doi: 10.1056/NEJMoa0803725.

    PMID: 18971490RESULT

  • Burns CM, Rutherford MA, Boardman JP, Cowan FM. Patterns of cerebral injury and neurodevelopmental outcomes after symptomatic neonatal hypoglycemia. Pediatrics. 2008 Jul;122(1):65-74. doi: 10.1542/peds.2007-2822.

    PMID: 18595988RESULT

  • Committee on Fetus and Newborn; Adamkin DH. Postnatal glucose homeostasis in late-preterm and term infants. Pediatrics. 2011 Mar;127(3):575-9. doi: 10.1542/peds.2010-3851. Epub 2011 Feb 28.

    PMID: 21357346RESULT

  • Cornblath M, Hawdon JM, Williams AF, Aynsley-Green A, Ward-Platt MP, Schwartz R, Kalhan SC. Controversies regarding definition of neonatal hypoglycemia: suggested operational thresholds. Pediatrics. 2000 May;105(5):1141-5. doi: 10.1542/peds.105.5.1141.

    PMID: 10790476RESULT

  • Duvanel CB, Fawer CL, Cotting J, Hohlfeld P, Matthieu JM. Long-term effects of neonatal hypoglycemia on brain growth and psychomotor development in small-for-gestational-age preterm infants. J Pediatr. 1999 Apr;134(4):492-8. doi: 10.1016/s0022-3476(99)70209-x.

    PMID: 10190926RESULT

  • Hay WW Jr, Raju TN, Higgins RD, Kalhan SC, Devaskar SU. Knowledge gaps and research needs for understanding and treating neonatal hypoglycemia: workshop report from Eunice Kennedy Shriver National Institute of Child Health and Human Development. J Pediatr. 2009 Nov;155(5):612-7. doi: 10.1016/j.jpeds.2009.06.044. No abstract available.

    PMID: 19840614RESULT

  • Wong DS, Poskitt KJ, Chau V, Miller SP, Roland E, Hill A, Tam EW. Brain injury patterns in hypoglycemia in neonatal encephalopathy. AJNR Am J Neuroradiol. 2013 Jul;34(7):1456-61. doi: 10.3174/ajnr.A3423. Epub 2013 Feb 22.

    PMID: 23436054RESULT

  • McKinlay CJ, Alsweiler JM, Ansell JM, Anstice NS, Chase JG, Gamble GD, Harris DL, Jacobs RJ, Jiang Y, Paudel N, Signal M, Thompson B, Wouldes TA, Yu TY, Harding JE; CHYLD Study Group. Neonatal Glycemia and Neurodevelopmental Outcomes at 2 Years. N Engl J Med. 2015 Oct 15;373(16):1507-18. doi: 10.1056/NEJMoa1504909.

    PMID: 26465984RESULT

  • Stevens B, Johnston C, Petryshen P, Taddio A. Premature Infant Pain Profile: development and initial validation. Clin J Pain. 1996 Mar;12(1):13-22. doi: 10.1097/00002508-199603000-00004.

    PMID: 8722730RESULT

  • Klonoff DC. The need for a glycemia modeling comparison workshop to facilitate development of an artificial pancreas. J Diabetes Sci Technol. 2010 Jan 1;4(1):1-3. doi: 10.1177/193229681000400101. No abstract available.

    PMID: 20167161RESULT

  • Galderisi A, Zammataro L, Losiouk E, Lanzola G, Kraemer K, Facchinetti A, Galeazzo B, Favero V, Baraldi E, Cobelli C, Trevisanuto D, Steil GM. Continuous Glucose Monitoring Linked to an Artificial Intelligence Risk Index: Early Footprints of Intraventricular Hemorrhage in Preterm Neonates. Diabetes Technol Ther. 2019 Mar;21(3):146-153. doi: 10.1089/dia.2018.0383.

    PMID: 30835533DERIVED

  • Galderisi A, Lago P, Steil GM, Ghirardo M, Cobelli C, Baraldi E, Trevisanuto D. Procedural Pain during Insertion of a Continuous Glucose Monitoring Device in Preterm Infants. J Pediatr. 2018 Sep;200:261-264.e1. doi: 10.1016/j.jpeds.2018.03.040. Epub 2018 May 31.

    PMID: 29861315DERIVED

Study Officials

  • Alfonso Galderisi, MD

    University Hospital of Padua

    PRINCIPAL INVESTIGATOR

  • Daniele Trevisanuto, MD

    University Hospital of Padua

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 19, 2015

First Posted

October 22, 2015

Study Start

October 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

August 10, 2016

Record last verified: 2016-08

Locations

IT(2)US(1)