Infant, Very Low Birth Weight Clinical Trial
— CGM&VLBWIOfficial title:
NEONATAL HYPOGLYCEMIA and CONTINUOUS GLUCOSE MONITORING: A RANDOMIZED CONTROLLED TRIAL IN PRETERM INFANTS
Verified date | August 2016 |
Source | University Hospital Padova |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 50 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 2 Days |
Eligibility |
Inclusion Criteria (and/or): - <= 32 weeks gestation - birthweight <1500 g Exclusion Criteria: - birthweight <500g - malformative syndrome - lack of parental consent - chromosomal abnormalities |
Country | Name | City | State |
---|---|---|---|
Italy | Department of Information Engineering - University of Padua | Padua | |
Italy | Neonatal Intensive Care Unit - University Hospital of Padua | Padua | |
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
University Hospital Padova | Boston Children’s Hospital, University of Padova |
United States, Italy,
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. 2 — View Citation
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 determ — View Citation
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-b — View Citation
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | In range - time | Percentage of time in range 72-144mg/dl | 7 days (minimum 2) | |
Secondary | Hypoglycemia | percentage of time below 40mg/dl | 7days | |
Secondary | Acute event associated to glycemic variability and/or hypoglycemia | Acute events (cerebral hemorrhage) and association with glycemic variability (specific patterns) | 7days | |
Secondary | Glycemic variability and hypoglycemia predictors | Evaluation of glycemic variability | 7days | |
Secondary | hypoglycemia prediction | Predictors of hypoglycemia: to individuate glycemic patterns/trends that could predict hypoglycemia | 7days | |
Secondary | Glycemic modeling | Creation of a glycemic modeling to predict hypoglycemia and to prevent it (see Klonoff DC et al J Diabetes Sci Technol. 2010) | 7days | |
Secondary | Pain associated to insertion of CGM respect to Pain associated to heel prick | PIPP scale will be used to compare CGM vs heel prick in each subject. The scale consists of a numeric score as described by Stevens B (Clin J Pain, 1996) | 7 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02913677 -
Prolonged Minimal Enteral Nutrition Versus Slowly Advancing Enteral Nutrition in Very Low Birth Weight Infants:
|
N/A | |
Completed |
NCT02379728 -
Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth
|
N/A | |
Completed |
NCT01341236 -
Near Infrared Spectroscopy (NIRS) and Superior Mesenteric Artery (SMA) Doppler Patterns as Predictor of Feeding Tolerance in Very Low Birth Weight (VLBW) IntraUterine Growth Restricted (IUGR) and NON IUGR Infants
|
Phase 4 | |
Completed |
NCT05217186 -
Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements
|
||
Completed |
NCT03082313 -
Movement-based Infant Intervention
|
N/A | |
Terminated |
NCT01430832 -
Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum
|
||
Terminated |
NCT02599545 -
Testosterone and Cortisol Levels in Infants
|
||
Active, not recruiting |
NCT01809548 -
Preterm Infants on Early Solid Foods
|
N/A | |
Completed |
NCT01363167 -
Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2
|
N/A | |
Completed |
NCT01193270 -
Vitamin E for Extremely Preterm Infants
|
Phase 1 | |
Completed |
NCT02078687 -
Growth, Risks of Allergy and Metabolic Syndrome in 6 Year Old Children Born Preterm Compared to Postdischarge Nutrition
|
N/A | |
Completed |
NCT00760942 -
Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants
|
N/A | |
Completed |
NCT02280031 -
Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial.
|
Phase 2 | |
Completed |
NCT01717625 -
The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia
|
Phase 2 | |
Completed |
NCT00601081 -
Human Milk Fortifier and Cytokine Profile
|
N/A | |
Completed |
NCT00009646 -
Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)
|
Phase 3 | |
Completed |
NCT00579943 -
Regulation of Cerebral Blood Flow in Very Low Birth Weight Infants
|
N/A | |
Completed |
NCT02389478 -
Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants
|
N/A | |
Recruiting |
NCT02016638 -
Sleep Quality in Pregnancy and Its Impact on Pregnancy Outcomes
|
N/A | |
Terminated |
NCT01799629 -
Efficacy of Prophylactic Glycerin Suppositories for Feeding Intolerance in Very Low Birth Weight Preterm Infants: a Randomized Trial
|
N/A |