Tokyo, March 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059612) titled 'The effectiveness of educational interventions to improve compliance with standard procedures for handling human milk in NICUs and GCUs' on March 31.

Study Type: Interventional

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

Primary Sponsor: Institute - Toho University

Condition: Condition - Not applicable Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In neonatal intensive care units (NICU) and growing care units (GCU), many infants are premature or extremely low birth weight. Nurses frequently handle expressed breast milk provided by mothers. Breast milk is essential in neonatal care because it reduces necrotizing enterocolitis, retinopathy of prematurity, chronic lung disease, and infections (Nagai Tate, Neonatal Care, 2018, Vol.31, No.7, p.631). Therefore, it must be handled safely. The 8th East Ward of Building No.2 at Toho University Medical Center Omori Hospital serves as both a NICU and a GCU. Breast milk is stored at room temperature, refrigerated, or frozen, each with different storage periods. Nurses must confirm the amount and expiration before preparation; mistakes may cause unnecessary disposal. Administration methods vary by infant condition, making procedures complex. Because of this, nurses in the NICU/GCU face a high risk of errors and waste. Compared with maternity or pediatric wards, storage and administration methods are more diverse, making it difficult to share preventive measures. The ward has two procedures for breast milk handling: (1) dividing and labeling expressed milk and (2) administering milk or breast milk. These are reviewed after incidents, but information sharing depends on each nurse, and education is insufficient. Over the past year, 66 nursing incidents were reported; 54 (81%) involved breast milk handling, and 39 (72%) led to disposal. In 34 cases, procedures were not followed, showing frequent noncompliance. This study aims to improve nurses adherence to procedures through educational intervention. By promoting understanding and behavioral change, we seek to reduce incidents and ensure safe, efficient management of breast milk for premature and low birth weight infants, improving patient safety and care quality. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Educational Intervention

Video Viewing

Create a video showing the standard procedures for handling breast milk (no patient personal information is used).

Participants view the video using Google Classroom.

Small-Group Face-to-Face Training

Nurses, excluding research members, are divided into small groups of 5-10 and training is held after shifts.

Content:

Explanation of procedures with low compliance rates

Q&A using a checklist

Demonstration of low-compliance procedures

Voluntary Participation

Nurses who do not consent to the study can still participate in the intervention.

Participation in video viewing, Q&A, and demonstration is voluntary.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - In the NICU (Neonatal Intensive Care Unit) and GCU (Growing Care Unit), many hospitalized infants are preterm or have extremely low birth weight. As a result, their mothers expressed breast milk must be handled within the units, which increases the likelihood of incidents such as disposal of breast milk or incorrect administration.

In the 8th East Ward of Building No2, ward nurses are responsible for handling the expressed breast milk of hospitalized infants. However, incidents such as disposal or incorrect administration of breast milk by these nurses have been reported.

This study targets the nurses of the 8th East Ward of Building No2, aiming to clarify behavioral changes resulting from an educational intervention and to evaluate the effectiveness of such an intervention. Key exclusion criteria - Members of the nursing research team and individuals who did not provide consent to participate in the study.

Individuals who were unable to participate in any of the educational intervention components (video viewing, group work, or demonstration). Target Size - 47

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 10 Month 17 Day Date of IRB - 2025 Year 10 Month 17 Day Anticipated trial start date - 2025 Year 11 Month 01 Day Last follow-up date - 2026 Year 03 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068107

Disclaimer: Curated by HT Syndication.