Tokyo, June 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061882) titled 'Evaluating nursing care to reduce nasal injury in premature babies on nCPAP' on June 11.

Study Type: Interventional

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

Primary Sponsor: Institute - Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan.

Condition: Condition - Nasal injury in preterm neonates receiving nasal Continuous Positive Airway Pressure (nCPAP) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare the incidence of nasal injury in preterm neonates requiring nCPAP between phase I (observation period: 2 months) and phase II (intervention period: 2 months). Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Observation (Control) group: All the premature neonates admitted in the phase I period who receive nCPAP will be enrolled. They will be observed for 2 months using usual practice. Interventions/Control_2 - Intervention group: In phase II period, all eligible premature neonates will be allocated to the intervention group, where they will receive care bundle intervention (2 months).

Eligibility: Age-lower limit - 1 weeks-old

Gender - Male and Female Key inclusion criteria - 1. All preterm neonates (before 37 completed weeks of gestation). 2. Preterm with Birth Weight of 600 gm to <2500 gm. 3. Preterm requiring nCPAP for more than 4 hours. 4. Preterm neonates whose parent or guardian consents to participate in the study. Key exclusion criteria - 1. Preterm neonates with congenital anomalies (diaphragmatic hernia, tracheoesophageal atresia, spina bifida, Edward syndrome) and skin diseases (epidermolysis bullosa, impetigo). 2. Preterm neonates with old scar or nasal injury (previously exposed). 3. Readmitted preterm neonates who were involved in the study previously. Target Size - 53

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 24 Day Date of IRB - 2026 Year 06 Month 11 Day Anticipated trial start date - 2026 Year 06 Month 15 Day Last follow-up date - 2026 Year 11 Month 15 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070807

Disclaimer: Curated by HT Syndication.