UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052797 |
|---|---|
| Receipt number | R000060131 |
| Scientific Title | Delayed Sustained Lung Inflation for Preterm Neonates in Neonatal Intensive Care Unit |
| Date of disclosure of the study information | 2023/11/14 |
| Last modified on | 2023/11/14 16:44:19 |
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Basic information
Public title
Respiratory effects of sustained lung inflation for neonates: A randomized controlled trial
Acronym
SLIN
Scientific Title
Delayed Sustained Lung Inflation for Preterm Neonates in Neonatal Intensive Care Unit
Scientific Title:Acronym
DSLIN
Region
| Asia(except Japan) |
Condition
Condition
Sustained lung inflation (SLI) right after birth to decrease the use of mechanical ventilation of preterm infants is controversial because of potential harm.
Classification by specialty
| Pneumology | Pediatrics | Intensive care medicine |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to evaluate the effects of delayed SLI conducted by experienced staff in the neonatal intensive care unit (NICU).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Use of mechanical ventilation
Key secondary outcomes
sepsis, intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), necrotizing enterocolitis (NEC), patent ductus arteriosus (PDA), retinopathy of prematurity (ROP), BPD, pneumothorax, and mortality
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) 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
| Maneuver |
Interventions/Control_1
Intervention: Sustained Lung Inflation (SLI) with 20 cm H2O for 15 sec was conducted by experienced staff in the eonatal Intensive Care Unit (NICU) between 30 min and 24 h after birth.
Interventions/Control_2
Control: No SLI.
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 (with a gestational age of 27 to 35 weeks) who required CPAP to provide positive end-expiratory pressure with or without intermittent positive pressure ventilation in the NICU of Chang Gung Memorial Hospital at Taipei were eligible for enrollment.
Key exclusion criteria
Neonates with pneumothorax or a major congenital anomaly (including severe congenital heart disease), and referral neonates who had been admitted to another NICU for more than 1 day.
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Yi-Hao |
| Middle name | |
| Last name | Weng |
Organization
Chang Gung Memorial Hospital at Taipei
Division name
Pediatrics
Zip code
105
Address
199 Dun-Hwa North Road, Taipei, Taiwan
TEL
886-2-27135211
yihaoweng@cgmh.org.tw
Public contact
Name of contact person
| 1st name | Yi-Hao |
| Middle name | |
| Last name | Weng |
Organization
Chang Gung Memorial Hospital at Taipei
Division name
Pediatrics
Zip code
105
Address
199 Dun-Hwa North Road, Taipei, Taiwan
TEL
886-2-27135211
Homepage URL
yihaoweng@cgmh.org.tw
Sponsor or person
Institute
Chang Gung Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Chang Gung Memorial Hospital
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chang Gung Memorial Hospital
Address
199 Dun-Hwa North Road, Taipei, Taiwan
Tel
886033196200#3716
yijiun@cgmh.org.tw
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
Chang Gung Memorial Hospital
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 14 | 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
45
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
| 2018 | Year | 09 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 09 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 22 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 26 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 14 | Day |
Last modified on
| 2023 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060131
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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