UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057318 |
|---|---|
| Receipt number | R000065494 |
| Scientific Title | 24hours use of Web-camera in the Neonatal Intensive Care Unit : A randomized control study |
| Date of disclosure of the study information | 2025/03/20 |
| Last modified on | 2025/03/17 20:34:26 |
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Basic information
Public title
24hours use of Web-camera in the Neonatal Intensive Care Unit : A randomized control study
Acronym
24hours use of Web-camera in the Neonatal Intensive Care Unit : A randomized control study
Scientific Title
24hours use of Web-camera in the Neonatal Intensive Care Unit : A randomized control study
Scientific Title:Acronym
24hours use of Web-camera in the Neonatal Intensive Care Unit : A randomized control study
Region
| Japan |
Condition
Condition
Parents who have newborns expected to stay in the NICU for more than 1 month were enrolled after obtaining written informed consent. No exclusion criteria in these population.
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of 24-hour web camera access for parents of infants in the NICU, as well as its impact on healthcare providers' workflow and communication.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome was the score on the Mother-Infant Bonding Scale (MIBS) reported by the parents one month after the baby's birth.
Key secondary outcomes
Secondary outcomes included the State-Trait Anxiety Inventory (STAI), the Family Image Technique (FIT), and salivary oxytocin levels measured twice after delivery and once at one month postpartum for both parents. The Edinburgh Postnatal Depression Scale (EPDS) was administered to mothers one month postpartum. Additionally, we recorded single milking capacity and visiting rate.
Participants in the web camera group completed a survey regarding their use of the web camera. Upon completion of the study, we conducted a survey with healthcare providers to assess the workflow impact of using the web camera.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The camera was installed on the incubator, ensuring clear visibility of the baby 24hours. An application compatible with the camera was installed on both parents' cell phones, allowing them toview the baby through the app.
Interventions/Control_2
No baby monitors at the bedside and normal visitation standards.
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
Parents who have newborns expected to stay in the Kyorin University NICU for more than 1 month were enrolled after obtaining written informed consent.
Key exclusion criteria
(1) Cases in which consent for participation in this study cannot be obtained from the parents.
(2) Baby's who are expected to be discharged from the NICU within 4 weeks.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | ozawa |
| Middle name | |
| Last name | yuri |
Organization
Kyorin University school of medicine, Tokyo, Japan
Division name
Department of pediatrics
Zip code
181-8611
Address
6-20-2 shinkawa Mitaka city Tokyo Japan
TEL
0422-47-5511
ozawa-y@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | ozawa |
| Middle name | |
| Last name | yuri |
Organization
Kyorin University school of medicine,
Division name
Department of pediatrics
Zip code
181-8611
Address
6-20-2 shinkawa Mitaka city Tokyo Japan
TEL
0422-47-5511
Homepage URL
ozawa-y@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University school of medicine
Institute
Department
Personal name
Funding Source
Organization
Terumo life science foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyorin University School of Medicine Ethics Committee
Address
6-20-2 shinkawa Mitaka city Tokyo Japan
Tel
0422-47-5511
rec@ks.kyorin-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
| 2025 | Year | 03 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
44
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
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 17 | Day |
Last modified on
| 2025 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065494
