UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032812 |
|---|---|
| Receipt number | 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 00:50:26 |
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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
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
alessandro.perri@policlinicogemelli.it
Sponsor or person
Institute
Catholic University of Sacred Heart, Department of Pediatrics, Division of Neonatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037353
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| Registered date | File name |
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