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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002912
Receipt No. 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

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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
Email 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
Email enrizecca@rm.unicatt.it

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

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003548

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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