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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000032812
Receipt No. R000037353
Scientific Title Strict glycemic control in VLBW infants at high risk of glycemic disorders using a Continuous Glucose Monitoring System: Randomized Controlled Clinical Trial
Date of disclosure of the study information 2018/05/31
Last modified on 2021/06/04

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Basic information
Public title Strict glycemic control in VLBW infants at high risk of glycemic disorders using a Continuous Glucose Monitoring System: Randomized Controlled Clinical Trial
Acronym Strict glycemic control in VLBW using a CGMS: RCT
Scientific Title Strict glycemic control in VLBW infants at high risk of glycemic disorders using a Continuous Glucose Monitoring System: Randomized Controlled Clinical Trial
Scientific Title:Acronym Strict glycemic control in VLBW using a CGMS: RCT
Region
Europe

Condition
Condition Prematurity
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of a strict glycemic control, using a CGM System, on a selected population of infants at high risk of glycemic disorders, fed with parenteral nutrition on the first week of life.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To achieve the reduction of 33% of dysglycemic episodes in the intervention arm.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Continuous glucose monitoring duration: at least 96h.
Glucose infusion rate is modulated using a 33% glucose solution administered by a central line catheter.
In the intervention group,62 mg/dl and 140 mg/dl, represent operative threshold requiring experimental modulation of the glucose infusion rate. If hyper-hypoglycemia occurs, glucose infusion rate is modulated accordingly to standard protocols.
Interventions/Control_2 Continuous glucose monitoring duration: at least 96h.
Glucose infusion rate is modulated using a 33% glucose solution administered by a central line catheter.
In the control group 47 mg/dl and 180 mg/dl represent operative threshold of hypo-hyperglycemia requiring standard modulation of glucose infusion rate.


Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. VLBW infants fed with Parenteral Nutrition during the first week of life.
2. VLBW and Small for Gestational Age (SGA) infants with a documented prenatal history of severe placental insufficiency (umbilical doppler sonography assessing AED or ARED or brain sparing)
Key exclusion criteria 1. Preterm infants with major congenital anomalies or chromosomic anomalies.
2. Infants not achieving a continuous glucose monitoring for more than 96 hours
3. Infants that need more than one replacement of the subcutaneous sensor
Target sample size 46

Research contact person
Name of lead principal investigator
1st name Giovanni
Middle name
Last name Vento
Organization Catholic University of Sacred Heart, Department of Pediatrics
Division name Division of Neonatology
Zip code 00168
Address Largo A. Gemelli, 8
TEL 00390630154357
Email giovanni.vento@unicatt.it

Public contact
Name of contact person
1st name Alessandro
Middle name
Last name Perri
Organization Catholic University of Sacred Heart, Department of Pediatrics
Division name Division of Neonatology
Zip code 00195
Address Largo A. Gemelli, 8
TEL 00390630154357
Homepage URL
Email alessandro.perri@policlinicogemelli.it

Sponsor
Institute Catholic University of Sacred Heart, Department of Pediatrics, Division of Neonatology
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Commitee of Policlinico A. Gemelli
Address Largo A. Gemelli, 8 Rome
Tel 00390630155556
Email comitato.etico@policlinicogemelli.it

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 31 Day

Related information
URL releasing protocol https://pubmed.ncbi.nlm.nih.gov/34039690/
Publication of results Published

Result
URL related to results and publications https://pubmed.ncbi.nlm.nih.gov/34039690/
Number of participants that the trial has enrolled 47
Results Dysglycaemic episodes and of infants with at least one episode of dysglycaemia was significantly lower in the intervention group: respectively 1 IQR 0 2 vs 3 IQR 1 7 p=0.005 and 12
52% vs 20 83% p=0.047. Infants managed using the strict protocol had a higher probability to have normal glycaemic values: relative risk 2.87 95% CI 1.1 to 7.3. The number needed to treat to avoid dysglycaemia episodes is 3.2
95% CI 1.8 to 16.6
Results date posted
2021 Year 06 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Standard group vs intervenction group (p):
Gestational Age 29 30 (0.5)
Birth weight 1002 1984 (0.83)
Small for gestational age (%) 35 33 (0.84)
Male (%) 57 67 (0.68)
Participant flow 63 neonates met the eligibility criteria during the study period. One had severe congenital skin alteration so he did not meet the inclusion criteria, parents declined to participate for seven infants, and seven were excluded because the CGMS was not available. The remaining 48 neonates were enrolled from October 2018 to September 2019. One baby in the STG group died in the first day of life. Forty- seven neonates completed the entire protocol, 23 in STG and 24 in CLG
Adverse events No adverse event related to the study protocol.
Outcome measures No different main outcome in the studied populations.
Also see table 2 here https://pubmed.ncbi.nlm.nih.gov/34039690/
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2018 Year 02 Month 09 Day
Date of IRB
2018 Year 03 Month 23 Day
Anticipated trial start date
2018 Year 06 Month 15 Day
Last follow-up date
2020 Year 03 Month 15 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 04 Month 15 Day
Date analysis concluded
2020 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 05 Month 31 Day
Last modified on
2021 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037353

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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