UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002912 |
|---|---|
| Receipt number | R000003548 |
| Scientific Title | Early weaning from incubator and early discharge of preterm infants |
| Date of disclosure of the study information | 2009/12/16 |
| Last modified on | 2014/11/05 04:10:36 |
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Basic information
Public title
Early weaning from incubator and early discharge of preterm infants
Acronym
Early weaning of preterm infants to open crib
Scientific Title
Early weaning from incubator and early discharge of preterm infants
Scientific Title:Acronym
Early weaning of preterm infants to open crib
Region
| Europe |
Condition
Condition
Prematurity
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess feasibility and safety of an earlier weaning from incubator in preterm infants, comparing outcomes between babies transferred from incubator to open crib at lower (1600 grams) versus higher (1800 grams) body weight.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Total length of stay lower for infants transferred to an open crib at 1600 grams
Key secondary outcomes
Number of infants requiring hospital readmissions during the first week after discharge not significantly higher for infants transferred to an open cot at 1600 g than for infants transferred at 1800 g.
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
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Weaning fron incubator to open crib at > 1600 g
Interventions/Control_2
Weaning from incubator to open crib at > 1800 g
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
Preterm infants whit birth weight < 1600 grams. Weight > 1600 grams at enrollment, medically stable, stable or increasing weight > 48 hours
Key exclusion criteria
Major congenital abnormality; respiratory support (CPAP or oxygen)
Target sample size
94
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Enrico Zecca |
Organization
Catholic University of the Sacred Heart
Division name
Neonatology
Zip code
Address
Largo Gemelli 8, 00168 Rome, Italy
TEL
+81-039630154169
enrizecca@rm.unicatt.it
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Enrico Zecca |
Organization
Catholic University of the Sacred Heart
Division name
Neonatology
Zip code
Address
Largo Gemelli 8, 00168 Rome, Italy
TEL
+81-039630154169
Homepage URL
enrizecca@rm.unicatt.it
Sponsor or person
Institute
Division of Neonatology, Department of Pediatrics, Catholic University of the Sacred Heart
Institute
Department
Personal name
Funding Source
Organization
Catholic University of the 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
Catholic University of the Sacred Heart, Division of Neonatology, Neonatal Pathology sub-intensive ward, Rome, Italy
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://pediatrics.aappublications.org/cgi/reprint/126/3/e651
Number of participants that the trial has enrolled
Results
Weaning moderately preterm infants from incubators to open cribs at 1600 g is safe and results in earlier discharge
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
Completed
Date of protocol fixation
| 2007 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 16 | Day |
Last modified on
| 2014 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003548
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
