UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051498 |
|---|---|
| Receipt number | R000058748 |
| Scientific Title | Inhaled nitric oxide (iNO) therapy for preterm infants after 7 days of age: a scoping review |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2025/01/05 10:21:32 |
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Basic information
Public title
Inhaled nitric oxide (iNO) therapy for preterm infants after 7 days of age: a scoping review
Acronym
Inhaled nitric oxide (iNO) therapy for preterm infants after 7 days of age: a scoping review
Scientific Title
Inhaled nitric oxide (iNO) therapy for preterm infants after 7 days of age: a scoping review
Scientific Title:Acronym
Inhaled nitric oxide (iNO) therapy for preterm infants after 7 days of age: a scoping review
Region
| Japan |
Condition
Condition
Bronchopulmonary dysplasia (BPD), Pulmonary hypertension, Neonatal hypoxic respiratory failure
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this scoping review is to identify the initiation criteria of iNO in preterm infants.
Basic objectives2
Others
Basic objectives -Others
To create the diagnostic criteria of pulmonary hypertension with BPD and the initiation criteria of iNO in preterm infants.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Initiation criteria of iNO
Key secondary outcomes
postnatal day of the iNO initiation, iNO concentration (ppm), duration of iNO, discontinuation criteria of iNO, other drugs, adverse effects
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 37 | weeks-old | > |
Gender
Male and Female
Key inclusion criteria
i) Preterm infants <37 weeks' gestation treated with iNO after 7 days of life
ii) Published between 2003 and 2022
iii) Conducted among developed countries
iv) Published in English or Japanese
v) Randomized controlled trial, cohort study, case-control study, and case series
Key exclusion criteria
i) Infants born more than 37 weeks of gestational age
ii) Initiation of iNO is before 7 days of life
iii) Infants with congenital malformation syndrome and a chromosomal abnormality
iv) Animal and in-vitro studies
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hidehiko |
| Middle name | |
| Last name | Nakanishi |
Organization
Kitasato University
Division name
Neonatology
Zip code
252-0375
Address
Kitasato1-15-1, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan
TEL
+81-42-778-8111
n0n.hide@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidehiko |
| Middle name | |
| Last name | Nakanishi |
Organization
Kitasato University
Division name
Neonatology
Zip code
252-0375
Address
Kitasato1-15-1, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan
TEL
+81-42-778-8111
Homepage URL
n0n.hide@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
+81-42-778-8111
n0n.hide@med.kitasato-u.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
| 2023 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
0
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
Main results already published
Date of protocol fixation
| 2023 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a scoping review, and no patient registration is planned.
Management information
Registered date
| 2023 | Year | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058748
