UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021785
Receipt No. 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 2016/04/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Hisaya Hasegawa
Organization Tokyo Women's Medical University Medical Center East
Division name Neonatology
Zip code
Address 2-1-10 Nishiogu, Arakawaku, Tokyo
TEL 03-3810-1111
Email hisayani@dnh.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Wasa
Organization Tokyo Women's Medical University Medical Center East
Division name Neonatology
Zip code
Address 2-1-10 Nishiogu, Arakawaku, Tokyo
TEL 03-3810-1111
Homepage URL
Email wasa.masanori@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University Medical Center East
Institute
Department

Funding Source
Organization Tokyo Women's Medical University Medical Center East
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
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

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 Open public recruiting
Date of protocol fixation
2016 Year 01 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 19 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
2016 Year 04 Month 05 Day
Last modified on
2016 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025069

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.