UMIN-CTR Clinical Trial

Public title

The effectiveness of educational interventions to improve compliance with standard procedures for handling human milk in NICUs and GCUs

Acronym

The effectiveness of educational interventions to improve compliance with standard procedures for handling human milk in NICUs and GCUs

Scientific Title

Not applicable

Scientific Title:Acronym

Not applicable

Region

Japan

Condition

Not applicable

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

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

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Number of incidents and accidents occurring before and after the educational intervention

Compliance rate with standard procedures for breast milk handling before and after the educational intervention

Educational Intervention Questionnaire

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Maneuver

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.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

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 sample size

47

Name of lead principal investigator

1st name	Kaede
Middle name
Last name	Arakaki

Organization

Toho University Omori Medical Center

Division name

Department of Nursing, East Ward, 8th Floor, Building 2

Zip code

143-8541

Address

6-11-1 Omorinishi, Ota-ku, Tokyo, Japan

TEL

03-3762-4151

Email

kaede.tokeshi@ns.toho-u.ac.jp

Name of contact person

1st name	Kaede
Middle name
Last name	Arakaki

Organization

Toho University Omori Medical Center

Division name

Department of Nursing, East Ward, 8th Floor, Building 2

Zip code

143-8541

Address

6-11-1 Omorinishi, Ota-ku, Tokyo, Japan

TEL

03-3762-4151

Homepage URL

Email

kaede.tokeshi@ns.toho-u.ac.jp

Institute

Toho University

Institute

Department

Personal name

Organization

Not applicable

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of the Faculty of Medicine, Toho University

Address

2nd Floor, Building No. 1, Faculty of Medicine, 5-21-16 Omorinishi, Ota-ku, Tokyo, Japan

Tel

03-3762-4151

Email

med.rinri@ext.toho-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

03

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Of 47 eligible participants, 43 (91.4%) consented; data from 40 (93.0%) who completed all interventions were analyzed. Adherence to standard procedures increased overall, but decreased in items without demonstration or Q&A. Incidents rose from 8 (3 disposals) pre-intervention to 13 (10 disposals) post-intervention. Of 39 respondents, all recognized the need for adherence and rated the intervention appropriate, though procedural complexity was noted as a possible cause of incidents.

Results date posted

2026

Year

03

Month

25

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

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

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2025

Year

11

Month

01

Day

Last modified on

2026

Year

03

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068107

Single case data URL

Value
https://center6.umin.ac.jp/ice/68107