Tokyo, June 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061840) titled 'Study on the effects of care using the Newborn Behavioral Observations (NBO) system' on June 9.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - University of Fukui

Condition: Condition - primiparous mothers and their firstborn infants aged approximately 8-12 weeks Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To examine how care using the Newborn Behavioral Observations (NBO) system affects changes in neurobiological foundations, such as maternal mental health and facial expression recognition ability, in parents and their infants aged up to approximately 3 months. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Implementation of care using the Newborn Behavioral Observations (NBO) system for parents and their infants Interventions/Control_2 - Control Group 1:Existing data stored in the relevant laboratory (without NBO intervention; with available MRI data) Participants must meet all of the following criteria. 1.Aged 18 years or older 2.Women who have given birth to their first child 3.Handedness: not specified 4.Mothers within 14 weeks postpartum as of the date of assessment

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - Mother:Participants must meet all of the following criteria. 1.Aged 18 years or older 2.Primiparous women (women who have given birth to their first child) 3.Mothers within 14 weeks postpartum by the day of the NBO session (for preterm infants, the corrected age must be within 14 weeks) 4.Those who are able to visit Fukui University Hospital with their infant at around 8 to 12 weeks postpartum 5.Handedness: Any (No restriction) 6.Those who have received a sufficient explanation regarding participation in this study, have reached a full understanding, and have provided voluntary written informed consent based on their own free will Key exclusion criteria - Mother:Candidates who meet any of the following criteria will be excluded from the study: 1.Individuals with an implanted cardiac or neural pacemaker 2.Individuals with metallic implants in their body, such as arterial clips 3.Individuals wearing orthodontic appliances (braces) 4.Individuals who experience claustrophobia (fear of enclosed spaces) or achluophobia (fear of dark spaces) 5.Individuals with a history of conditions such as a hernia who are unable to maintain the same posture for an extended period 6.Individuals with severe physical or mental disorders 7.Any other individuals judged by the principal investigator or sub-investigator to be unsuitable as a study participant Target Size - 100

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2024 Year 12 Month 01 Day Date of IRB - 2024 Year 09 Month 13 Day Anticipated trial start date - 2024 Year 12 Month 20 Day Last follow-up date - 2026 Year 08 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070754

Disclaimer: Curated by HT Syndication.