Clinical Trial: An Exploratory Study of the Implementation Outcomes and Challenges of a Positional Cranial Deformity Prevention Program for Preterm Infants in the NICU (Japan)

Tokyo, July 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062226) titled 'Evaluation of a Positional Cranial Deformity Prevention Program for Preterm Infants in the NICU' on July 13.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Fukuoka University

Condition: Condition - Positional Cranial Deformity Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to implement a newly developed positional cranial deformity prevention program for preterm infants admitted to the NICU of our hospital and to evaluate its effectiveness and implementation challenges. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - A positional cranial deformity prevention program will be implemented for preterm infants admitted to the NICU. The program consists of 1) head assessment three times daily, 2) repositioning every 2 to 3 hours including during feeding and nursing care, 3) head support during feeding, and 4) tummy time for 10 to 20 minutes three times daily under nurse supervision with cardiorespiratory monitoring.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Infants whose parent or legal guardian provides informed consent for study participation within 2 weeks after admission (consent from either the mother or father is acceptable). Infants born at less than 34 weeks of gestation. Key exclusion criteria - Infants with extremely low birth weight (birth weight less than 1000 g). Infants with congenital anomaly syndromes (including chromosomal abnormalities, muscular torticollis, and craniosynostosis). Infants with severe neonatal asphyxia. Infants requiring surgical intervention. Infants who are considered inappropriate for participation in this study by the principal investigator. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 01 Day Anticipated trial start date - 2026 Year 07 Month 14 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071207

Disclaimer: Curated by HT Syndication.