UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061882 |
|---|---|
| Receipt number | R000070807 |
| Scientific Title | Evaluation of Nurse-led standard nasal Continuous Positive Airway Pressure (nCPAP) care bundle on reducing the nCPAP-related nasal injury in preterm neonates using a Quasi Experimental Study in a level III Neonatal Intensive Care Unit of a tertiary hospital in Bhutan. |
| Date of disclosure of the study information | 2026/06/11 |
| Last modified on | 2026/06/11 22:11:36 |
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Basic information
Public title
Evaluating nursing care to reduce nasal injury in premature babies on nCPAP
Acronym
nCPAP-Nasal Care
Scientific Title
Evaluation of Nurse-led standard nasal Continuous Positive Airway Pressure (nCPAP)
care bundle on reducing the nCPAP-related nasal injury in preterm neonates using a Quasi
Experimental Study in a level III Neonatal Intensive Care Unit of a tertiary hospital in Bhutan.
Scientific Title:Acronym
nCAPP-NI in premature neonates
Region
| Asia(except Japan) |
Condition
Condition
Nasal injury in preterm neonates receiving nasal Continuous Positive Airway Pressure (nCPAP)
Classification by specialty
| Pediatrics | Intensive care medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the incidence of nasal injury in preterm neonates requiring nCPAP between
phase I (observation period: 2 months) and phase II (intervention period: 2 months).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of nCPAP related nasal injury
Key secondary outcomes
1. Severity of nasal injury
2. Time of first injury
3. Adherence to care bundle
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Observation (Control) group: All the premature neonates admitted in the phase I period who receive nCPAP will be enrolled. They will be observed for 2 months using usual practice.
Interventions/Control_2
Intervention group: In phase II period, all eligible premature neonates will be allocated to the intervention group, where they will receive care bundle intervention (2 months).
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
| 1 | weeks-old | < |
Age-upper limit
| 4 | weeks-old | > |
Gender
Male and Female
Key inclusion criteria
1. All preterm neonates (before 37 completed weeks of gestation).
2. Preterm with Birth Weight of 600 gm to <2500 gm.
3. Preterm requiring nCPAP for more than 4 hours.
4. Preterm neonates whose parent or guardian consents to participate in the study.
Key exclusion criteria
1. Preterm neonates with congenital anomalies (diaphragmatic hernia,
tracheoesophageal atresia, spina bifida, Edward syndrome) and skin diseases
(epidermolysis bullosa, impetigo).
2. Preterm neonates with old scar or nasal injury (previously exposed).
3. Readmitted preterm neonates who were involved in the study previously.
Target sample size
53
Research contact person
Name of lead principal investigator
| 1st name | Yeshey |
| Middle name | |
| Last name | Tshomo |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Science, Hiroshima University (Research to be conducted at NICU, JDWNRH, Bhutan)
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Japan
TEL
70-9228-4863
yetsho.jks09@gmail.com
Public contact
Name of contact person
| 1st name | Yeshey |
| Middle name | |
| Last name | Tshomo |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Science, Hiroshima University
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Japan
TEL
70-9228-4863
Homepage URL
yetsho.jks09@gmail.com
Sponsor or person
Institute
Graduate School of Biomedical and Health Science,
Hiroshima University,
Hiroshima,
Japan.
Institute
Department
Personal name
Hiroshima University
Funding Source
Organization
Japan International Cooperation Agency (JICA)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japanese
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Khesar Gyalpo University of Medical Sciences of Bhutan (KGUMSB)
Address
Office of the President, KGUMSB, Upper Taba, Thimphu, Bhutan
Tel
irbkgumsb@gmail.com
irbkgumsb@gmail.com
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
Neonatal ICU,
Jigme Dorji Wangchuck Referral Hospital,
Thimphu, Bhutan
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
| 2026 | Year | 11 | Month | 15 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 11 | Day |
Last modified on
| 2026 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070807
