Tokyo, July 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058447) titled 'Intervention Studies for the Prevention of Cranial Deformities in Infants' on July 13.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Historical
Primary Sponsor:
Institute - Nagasaki University
Condition:
Condition - Plagiocephaly in infants
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To prevent cranial deformities in infants
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Distortion Prevention Methods
Eligibility:
Age-lower limit - 1
days-old
=
Gender - Male and Female
Key inclusion criteria - As for the mothers, pregnant women undergoing antenatal care at 34-36 weeks' gestation.
For infants, infants born to mothers who participated in the study.
Key exclusion criteria - For mothers, a history of mental illness, etc.
For the child, there is no special provision.
Target Size - 260
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 03 Month 04 Day
Date of IRB - 2025 Year 03 Month 04 Day
Anticipated trial start date - 2025 Year 04 Month 30 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066827
Disclaimer: Curated by HT Syndication.
