UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021785 |
|---|---|
| Receipt number | R000025069 |
| Scientific Title | Effectiveness of MIST (minimally invasive surfactant therapy) under bronchoscopy in treating neonatal respiratory distress syndrome |
| Date of disclosure of the study information | 2016/04/05 |
| Last modified on | 2023/10/11 11:23:15 |
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Basic information
Public title
Effectiveness of MIST (minimally invasive surfactant therapy) under bronchoscopy in treating neonatal respiratory distress syndrome
Acronym
Minimally invasive surfactant therapy under bronchoscopy in treating neonatal respiratory distress syndrome
Scientific Title
Effectiveness of MIST (minimally invasive surfactant therapy) under bronchoscopy in treating neonatal respiratory distress syndrome
Scientific Title:Acronym
Minimally invasive surfactant therapy under bronchoscopy in treating neonatal respiratory distress syndrome
Region
| Japan |
Condition
Condition
Neonatal respiratory distress syndrome
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have designed a mode of minimally invasive surfactant therapy using a thin bronchoscope. A thin bronchoscope is inserted into the trachea, and surfactant is administered through the working channel under direct observation. The objective of this study is to assess the effectiveness of this mode which has no need for endotracheal intubation or the use of a laryngoscope.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Short term prognosis of respiration in patients treated with bronchoscopic MIST.
Short term prognosis of respiration includes the following
1. Days under mechanical ventilation
2. Days under supplemental oxygen
3. Incidence of airway diseases
4. Need for endotracheal intubation or additional surfactant
Key secondary outcomes
1. Morbidity of diseases often seen in premature infants(intraventricular hemorrhage, pneumothorax, patent ductus arteriosus, bronchopulmonary dysplasia, sepsis, necrotizing enterocolitis)
2. Length of hospitalization, mortality rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Place the infant inside the incubator and start nasal continuous positive airway pressure. Displace one of the prongs, and insert the bronchoscope from the open nostril. Place the tip of the bronchoscope inside the trachea. Slowly inject artificial lung surfactant (120mg per 1kg dissolved in normal saline) through the working channel. Push the surfactant inside the working channel with air. Remove the bronchoscope after confirming opening of the trachea. Place the prong back into the nostril.
Interventions/Control_2
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
Patients fulfilling all of the following criteria will be included
1. Patients born at Tokyo Women's Medical University Medical Center East, and admitted to the NICU
2. Patients diagnosed with respiratory distress syndrome
3. Informed consent obtained from parents
4. Patients thought to be appropriate for the study by the attending physician
Key exclusion criteria
Patients fulfilling any of the following criteria will be excluded
1. Patients with severe birth asphyxia
2. Patients with multiple malformation syndrome, or other suspected underlying diseases
3. Patients needing vasoactive drugs
4. Patients with tendency to bleed
5. Patients with congenital infections
6. Patients thought to be inappropriate for the study by the supervising physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hisaya |
| Middle name | |
| Last name | Hasegawa |
Organization
Tokyo Women's Medical University Adachi Medical Center
Division name
Neonatology
Zip code
123-8558
Address
4-33-1 Kohoku, Adachiku, Tokyo
TEL
03-3857-0111
hisayani@dnh.twmu.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Wasa |
Organization
Tokyo Women's Medical University Adachi Medical Center
Division name
Neonatology
Zip code
123-8558
Address
4-33-1 Kohoku, Adachiku, Tokyo
TEL
03-3857-0111
Homepage URL
wasa.masanori@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University Adachi Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University Adachi Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University Ethics Committee
Address
8-1, Kawadacho, Shinjukuku, Tokyo
Tel
03-3353-8111
Krinri.bm@twmu.ac.jp
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
| 2016 | Year | 04 | Month | 05 | 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
| 2016 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 05 | Day |
Last modified on
| 2023 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025069
