NCT06824597

Brief Summary

This study aims to evaluate the impact of Baby Friendly Hospital Initiative training program on nurses' and mothers' breastfeeding practices and experiences. Research Hypotheses

  • Maternity nurses who participate in the Baby Friendly Hospital Initiative training program exhibit improvement in breastfeeding practice scores and more positive breastfeeding experiences after the training program than before.
  • Breastfeeding mothers who receive Baby Friendly Hospital Initiative support have good breastfeeding practices and more positive breastfeeding experiences.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 13, 2025

Status Verified

January 1, 2025

Enrollment Period

9 months

First QC Date

January 31, 2025

Last Update Submit

February 7, 2025

Conditions

Keywords

training program - breastfeeding- practices-experiences

Outcome Measures

Primary Outcomes (2)

  • Evaluating the nurses' experiences regarding baby-friendly hospital initiative training program

    Interview questionnaire sheet will be adapted from (Gerhardsson, Oras, Mattsson, Blomqvist \& Funkquist, 2022) and will be translated into Arabic by the researcher. It will consist of two parts: Part (1): Demographic and professional characteristics of the nurses. Part (2): Nurses' experiences regarding BFHI training program questionnaire: Before the training program, the nurses will be asked two questions: (Do you think breastfeeding is an interesting part of your job? / Do you think your role is important in improving breastfeeding support in the healthcare continuum). After the training program, the nurses will be asked whether their interest in breastfeeding increased during the training and whether they had received new tools that they could use when providing breastfeeding support.

    3 months

  • Evaluating the nurses' practices regarding BFHI principles

    Observational checklist to observe the nurses' practices regarding BFHI principles will be adapted from (Timalsina, 2020) and will consist of 10 items such as a demonstration of proper positioning, attachment, and rooming in….etc. Scoring system: The total practice score equals 10 and the nurses will be given a score (2) for done correctly, a score (1) for done incorrectly and a score (0) for not done. It will be classified into: poor for \<50%, satisfactory 50-70%, and good practice \>70%.

    3 months

Secondary Outcomes (2)

  • Evaluating the secondary outcome of the training program for nurses on breastfeeding mothers' self- reported practices regarding the baby-friendly hospital initiative principles before and after the program.

    6 months

  • Evaluating the impact of the training program on mothers' experiences regarding breastfeeding

    6 months

Study Arms (2)

training program for nurses

EXPERIMENTAL

The Baby Friendly Hospital Initiative training program will be conducted for maternity nurses at the inpatient postpartum wards (9, 10, 15 and 18) and the delivery unit in Mansoura University Hospital (MCH), Dakahlia governorate, Egypt.

Behavioral: Baby-friendly hospital initiative training program

evaluating the outcome of the training program on breastfeeding mothers' practices

NO INTERVENTION

Before the training program, the first group of mothers (47 mothers) will be interviewed at the postpartum wards after delivery and the researcher will evaluate their self-reported breastfeeding practices during their hospital stay. After the training program, the second group (homogeneous) of mothers (47 mothers) will be interviewed at the postpartum wards after delivery and the researcher will evaluate their self-reported breastfeeding practices during their hospital stay.

Interventions

The Baby-Friendly Hospital Training Program is a critical intervention to improve maternal and infant health outcomes by promoting and supporting breastfeeding worldwide. It empowers the maternity nurses in this study to create an environment that prioritizes the needs of mothers and babies, ensuring the best possible start to life. It will be conducted for eight sessions (theoretical and practical), each session for about 20-30 minutes. It will include the importance of early initiation of breastfeeding, skin-to-skin contact immediately after birth, the importance of exclusive and continued breastfeeding, positions of breastfeeding, the importance of avoiding pre-lacteal feeds and unnecessary supplementation, advantages of rooming-in, and how to manage common breast and nipple conditions. The researcher will design an Arabic booklet and distribute it to the nurses at the first session as a guide to reinforce the teaching

training program for nurses

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • For nurses: all nurses who were working at inpatient postpartum wards and the delivery unit in Mansoura University Hospital with at least one year of work experience and who were providing direct care to the mothers and their newborns
  • For mothers:
  • Who had the intention to breastfeed.
  • Primiparous women
  • Age between 18 and 35 years.
  • Who had given birth to a singleton baby.
  • Free from serious medical or obstetrical complications.

You may not qualify if:

  • Breastfeeding mothers will be excluded from the study if their baby had:
  • Born before 37 weeks of gestation.
  • An Apgar score of less than 8 at 5 minutes.
  • A birthweight of less than 2,500 g.
  • Born with severe medical conditions or congenital malformations.
  • Admitted to the neonatal intensive care unit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing, Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Related Publications (2)

  • Hawkins SS, Stern AD, Baum CF, Gillman MW. Compliance with the Baby-Friendly Hospital Initiative and impact on breastfeeding rates. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F138-43. doi: 10.1136/archdischild-2013-304842. Epub 2013 Nov 25.

    PMID: 24277661BACKGROUND
  • Ducharme-Smith K, Gross SM, Resnik A, Rosenblum N, Dillaway C, Orta Aleman D, Augustyn M, Silbert-Flagg J, Caulfield LE. Exposure to Baby-Friendly Hospital Practices and Breastfeeding Outcomes of WIC Participants in Maryland. J Hum Lact. 2022 Feb;38(1):78-88. doi: 10.1177/0890334421993771. Epub 2021 Feb 16.

    PMID: 33591853BACKGROUND

Related Links

Study Officials

  • Abeer Ali, Ass.lecturer

    Faculty of Nursing, Mansoura University, Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abeer Sa Ali, Ass.lecturer

CONTACT

Samia Othman, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: A quasi-experimental research design will be utilized. A quasi-experimental design is often described as a non-randomized, pre-post-intervention study, in which patients self-select into different treatments instead of being randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

January 31, 2025

First Posted

February 13, 2025

Study Start

February 1, 2025

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

February 13, 2025

Record last verified: 2025-01

Locations