臨床研究等提出・公開システム

Japanese

Date of registration	Aug. 10, 2026
Last modified on	Aug. 10, 2026
Trial ID	jRCT1040260102

Scientific Title	Evaluation of the Effectiveness of Interventions Using Newborn Behavioral Observations (NBO) in the Neonatal Intensive Care Unit (NICU) (NICU-NBO Trial)
Public Title	Study of the effects of Newborn Behavioral Observations (NBO) for mothers and preterm infants in the NICU (NICU-NBO Trial)

Contact for Scientific Queries	Name	Nagai Yukiyo
	Affiliation	Nagoya City University Graduate School of Medical Sciences
	Address	1 Kawasumi Mizuho-cho Mizuhoku Nagoya Aichi Japan
	Telephone	+81-52-853-8760
	E-mail	ynagai390503@gmail.com
Contact for Public Queries	Name	Nagai Yukiyo
	Affiliation	Nagoya City University Graduate School of Medical Sciences
	Address	1 Kawasumi Mizuho-cho Mizuhoku Nagoya Aichi Japan
	Telephone	+81-52-853-8760
	E-mail	ynagai390503@gmail.com

Recruitment status	Pending

Anticipated date of first enrollment		Sept. 01, 2026
Target sample size		150
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Infants born at less than 34 gestational weeks and admitted to the NICU, along with their mothers
	Exclusion Criteria	Mothers must be able to complete a questionnaire in Japanese
	Age Minimum	No limit
	Age Maximum	1age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		preterm birth
Intervention(s)		Conducting two NBO sessions with preterm infants hospitalized in the NICU and their mothers. The sessions aim to elicit 18 types of responses from the infant examining the autonomic nervous system, motor behavior, organizational state, and reactivity and share these observations with the mother to deepen her understanding and empathy toward the child. The session takes 15-30 minutes to complete. The facilitator creates a shared time and space for interaction, thereby enhancing the sensitivity and responsiveness between parent and child.
Health Condition(s) Keyword		preterm infant, Newborn Behavioral Observations (NBO)
Intervention(s) Keyword		Neonatal Behavioral Observations (NBO)
Health Condition(s) Code		D047928
Intervention(s) Code		D010287
Primary Outcome(s)		Edinburgh Postnatal Depression Scale (EPDS)
Secondary Outcome(s)		1. Momther-Infant Bonding Scale (MIBS) 2. maternal salivary oxytocin concentration 3. Questionnaire after NBO or Usual care

Secondary Sponsor

Source of Monetary Support	Ministry of Education, Culture, Sports, Science and Technology (MEXT) Grant-in-Aid for Scientific Research (Grant Number 25K14015)
Secondary Sponsor

Name of Certified Review Board	Nagoya City University Medical Research Ethics Review Committee
Address	1 Kawasumi Mizuho-cho Mizuhoku Nagoya Aichi Japan, Aichi
Telephone	+81-52-853-8346
E-Mail	rinshou-kenkyu@med.nagoya-cu.ac.jp
Approval Status	Approval
Date of approval	July. 25, 2026

Plan to share IPD	Yes
Plan description	Data Management Using REDCap

Secondary ID(s)	5113
Issuing Authority	Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital Clinical Trials and Research Review Co

Countries of Recruitment（Except Japan）	none