UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010515 |
|---|---|
| Receipt number | R000012298 |
| Scientific Title | Randomized clinical trial on the safety and the efficacy of Tegaderm for the prevention of hypernatremic dehydratation in preterm infants |
| Date of disclosure of the study information | 2013/09/25 |
| Last modified on | 2016/10/19 01:16:51 |
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Basic information
Public title
Randomized clinical trial on the safety and the efficacy of Tegaderm for the prevention of hypernatremic dehydratation in preterm infants
Acronym
Tegaderm use in preterm infants
Scientific Title
Randomized clinical trial on the safety and the efficacy of Tegaderm for the prevention of hypernatremic dehydratation in preterm infants
Scientific Title:Acronym
Tegaderm use in preterm infants
Region
| Europe |
Condition
Condition
hypernatremic dehydratation
Classification by specialty
| Pediatrics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of Tegaterm use on the incidence of the hypernatremic dehydratation in preterm infants with gestational age below 30 weeks
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of hypernatremia (plasma sodium > 145 mEq/L)
Key secondary outcomes
Maximum weight loss, birth weight regain, hypotermia, hypertermia, intraventricular haemorrhage, sepsis, patent ductus arteriosus, systemic hypotension, bronchopulmonary dysplasia, necrotizing enterocolitis, retinopathy of prematurity, lenght of stay
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
application of Tegaderm whitin 24 hour of life
Interventions/Control_2
no treatment
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
inborn newborn infants with gestational age < 30 weeks
Key exclusion criteria
major congenital malformations, chromosomal abnormalities, congenital infections, acute renal insufficiency
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Costantino Romagnoli |
Organization
Catholic University of Sacred Heart
Division name
Division of Neonatology
Zip code
Address
Largo A. Gemelli, 8
TEL
+390630154357
enrizecca@rm.unicatt.it
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Simonetta Costa |
Organization
Catholic University of Sacred Heart
Division name
Division of Neonatology
Zip code
Address
Largo A. Gemelli, 8
TEL
+390630154357
Homepage URL
simocosta@yahoo.it
Sponsor or person
Institute
Catholic University of Sacred Heart
Institute
Department
Personal name
Funding Source
Organization
Catholic University of Sacred Heart
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Italy
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2013 | Year | 04 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 17 | Day |
Last modified on
| 2016 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012298
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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