UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037229 |
|---|---|
| Receipt number | R000042446 |
| Scientific Title | Effects of the Newborn Behavioral Observations (NBO) as early relationship support intervention for preterm babies and their mother. |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2024/05/13 22:49:19 |
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Basic information
Public title
Effects of the Newborn Behavioral Observations (NBO) as early relationship support intervention for preterm babies and their mother.
Acronym
Effects of the Newborn Behavioral Observations on preterm infant-parent relationship.
Scientific Title
Effects of the Newborn Behavioral Observations (NBO) as early relationship support intervention for preterm babies and their mother.
Scientific Title:Acronym
Effects of the Newborn Behavioral Observations on preterm infant-parent relationship.
Region
| Japan |
Condition
Condition
preterm infants and their mothers
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyze the effect of the Newborn Behavioral Observations on relationship between preterm infant-mother dyad.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Emotional Availability scale points of mother-infant dyad before discharge from NICU, 4 and 10 months corrected ages.
Key secondary outcomes
The postpartum depression scale (EPDS) points of mothers and the developmental scale (Vineland-II) points of infants.
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention group with administration of the Newborn Behavioral Observations.
Interventions/Control_2
The control group without administartion of the Newborn Behavioral Observations.
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 | days-old | < |
Age-upper limit
| 365 | days-old | > |
Gender
Male and Female
Key inclusion criteria
1. Preterm infants and their mothers born and gave birth at the research hospital.
Key exclusion criteria
1. Congenital disease
2. Transferred to another hospital or death.
3. Mothers with psychiatric disease, who are assessed as appropriate to be separated from her infant.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Shouichi |
| Middle name | |
| Last name | Ohga |
Organization
Faculty of Medical Sciences, Kyushu University
Division name
Department of Pediatrics
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5421
ohgas@pediatr.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Ochiai |
Organization
Faculty of Medical Sciences, Kyushu University
Division name
Department of Perinatal and Pediatric Medicine
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-5421
Homepage URL
ochimasa@pediatr.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Faculty of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Meiji Yasuda Mental Health 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
Kyushu University Certified Institutional Reviews Board for Clinical Trials
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Tel
092-642-5082
byskenkyu@jimu.kyushu-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
| 2019 | Year | 07 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2019 | 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
Management information
Registered date
| 2019 | Year | 07 | Month | 01 | Day |
Last modified on
| 2024 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042446
