UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015061 |
|---|---|
| Receipt number | R000017477 |
| Scientific Title | A pilot study to assess the efficacy and safety of Heliox inhalation therapy for resuscitation to preterm infants. |
| Date of disclosure of the study information | 2014/09/04 |
| Last modified on | 2014/09/04 19:04:28 |
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Basic information
Public title
A pilot study to assess the efficacy and safety of Heliox inhalation therapy for resuscitation to preterm infants.
Acronym
Heliox inhalation therapy for preterm infants
Scientific Title
A pilot study to assess the efficacy and safety of Heliox inhalation therapy for resuscitation to preterm infants.
Scientific Title:Acronym
Heliox inhalation therapy for preterm infants
Region
| Japan |
Condition
Condition
preterm infants
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assess to reduce preterm infants(30-37 week gestational age) who need intubation within the first 7 days after birth, with neonatal cardiopulmonary resuscitation(NCPR) used Heliox(21% oxygen and 79% helium mixture gas)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
intubation rate within the first 7 days after birth
Key secondary outcomes
efficacy(duration of ventilator support,CPAP, and oxygen inhalation, length of NICU stay)
safety(mortality, incidence of adverse ivents)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
According to NRP(neonatal resuscitation program) protocol, subjects are treated with not standard air but heliox.
Interventions/Control_2
in one year before same study period, infants who meet the inclusion criteria.
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
| 0 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Infants who is born at Nagano Children's hospital
(2) Infants between 30 and 36 weeks of gestational age
(3) Infants requiring mask PEEP or Bag mask bagging according to NRP(neonatal resuscitation program) protocol
(4) written informed consents were obtained from their parents
Key exclusion criteria
(1) infants who was suspected severe congenital heart disease before birth
(2) infants who was suspected chromosomal abnormality before birth
(3) infants who was suspected multiple malformation before birth
(4) infants who was suspected severe surgical disease before birth
(5)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Arata Oda |
Organization
Nagano Children's Hospital
Division name
Division of Neonatology
Zip code
Address
3100 Toyoshina, Azumino-city, Nagano
TEL
0263-73-6700
araoda@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Arata Oda |
Organization
Nagano Children's Hospital
Division name
Division of Neonatology
Zip code
Address
3100 Toyoshina, Azumino-city, Nagano
TEL
0263-73-6700
Homepage URL
araoda@gmail.com
Sponsor or person
Institute
Nagano Children's Hospital
Institute
Department
Personal name
Funding Source
Organization
AIR WATER R&D CO.,LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
長野県立こども病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 04 | 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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 04 | Day |
Last modified on
| 2014 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017477
