UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045529 |
|---|---|
| Receipt number | R000051684 |
| Scientific Title | Identification of risk factors for severe bronchopulmonary dysplasia in extremely premature infants: a scoping review |
| Date of disclosure of the study information | 2021/09/22 |
| Last modified on | 2025/03/25 12:58:58 |
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Basic information
Public title
Identification of risk factors for severe bronchopulmonary dysplasia in extremely premature infants: a scoping review
Acronym
Identification of risk factors for severe bronchopulmonary dysplasia in extremely premature infants: a scoping review
Scientific Title
Identification of risk factors for severe bronchopulmonary dysplasia in extremely premature infants: a scoping review
Scientific Title:Acronym
Identification of risk factors for severe bronchopulmonary dysplasia in extremely premature infants: a scoping review
Region
| Japan |
Condition
Condition
bronchopulmonary dysplasia
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this scoping review is to screen available evidence and identify risk factors associated with the development and severity of BPD.
Basic objectives2
Others
Basic objectives -Others
To establish a novel, useful BPD classification, which is able to predict long-term prognosis in good precision.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk factors associated with severe BPD defined by NICHD in 2001
Key secondary outcomes
antenatal therapy (e.g. antenatal corticosteroid), maternal condition (chorioamnionitis), neonatal condition (gender, gestational age, birth weight, small for gestational age), morbidities (patent ductus arteriosus, sepsis), neonatal therapy (nutrition, invasive respiratory support, oxygen, postnatal steroid, caffein)
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
| 28 | weeks-old | > |
Gender
Male and Female
Key inclusion criteria
a. Risk factors associated with severe BPD defined by NICHD2001(oxygen therapy of more than 30% at 36 weeks of corrected gestational age, or positive pressure respiratory support).
b. Published between 2002 and 2021.
c. Conducted among developed countries.
d. Published in English or Japanese.
e. Randomized controlled trial, any cohort study, case- control study
Key exclusion criteria
a. Infants born more than 28 weeks of gestational age.
b. Any congenital airway diseases such as diaphragmatic hernia and congenital pulmonary airway malformations.
c. Descriptive studies as well as animal and in vitro studies
.
d. Protocols
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
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
Neonatal Intensive Care Medicine
Zip code
252-0375
Address
Kitasato1-15-1, Minami-ku, Sagamihara, Kanagawa
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
Research program on rare and intractable diseases, Health, Labour and Welfare Sciences Research Grants
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
N/A
N/A
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
| 2021 | Year | 09 | Month | 22 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/14/2/e080298.info
Publication of results
Published
Result
URL related to results and publications
https://bmjopen.bmj.com/content/14/12/e087740
Number of participants that the trial has enrolled
10
Results
Although echocardiography is currently the primary diagnostic tool for identifying PH in preterm infants, standardised diagnostic criteria are lacking. Further, reports of complications and side effects associated with iNO are rare.
Results date posted
| 2025 | Year | 03 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No particular patients were included.
Participant flow
10 research were identified from 1518 original reports identified through literature search.
Adverse events
non
Outcome measures
the initiation criteria of iNO, postnatal day of the iNO initiation, dosage of iNO (ppm), duration of iNO therapy, discontinuation criteria of iNO therapy, concomitant use of other drugs and adverse effects
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 09 | Month | 21 | Day |
Last modified on
| 2025 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051684
