Breastfeeding OutcomesBFHINCT06824597
Impact of Baby-friedly Hospital Initiative (BFHI) Training Program on Breastfeeding Practices
A study testing Baby-friendly hospital initiative training program in people with Breastfeeding Outcomes, run by Mansoura University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Breastfeeding Outcomes
- What is being tested?
- Baby-friendly hospital initiative training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Samia Othman, professor contact
Egypt1 site
Faculty of Nursing, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Impact of Baby Friendly Hospital Initiative Training Program on Nurses' and Mothers' Breastfeeding Practices and Experiences
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.
Read the detailed description
Breastfeeding is a long-time investment in women's and babies' lives, not just a personal decision. World Health Organization (WHO) recommends breast milk as the most appropriate food for infants under six months of age. Breast milk contains all the nutrients that babies need in the first six months of life, so it is an ideal food for infants . Children who were breastfed had a lower risk of obesity and chest problems. Furthermore, breastfeeding mothers also benefited from breastfeeding, with lower rates of breast cancer, ovarian cancer, type II diabetes, and postnatal depression.
Exclusive breastfeeding (EBF) has been identified as the single most effective intervention for child survival, with the potential to prevent 13% of under-five deaths annually in low- and middle-income settings . WHO and United Nations Children's Fund (UNICEF) recommend optimal infant and young child feeding as immediate and early initiation of breastfeeding within the first hour of birth, EBF for the first 6 months of life, and with complementary feeding up to 2 years of age.
Early cessation of breastfeeding is a public health concern, especially in high-income countries, where only 25% of children were breastfeeding at 12 months of age, far below the global average of 74%. Women often cited difficulties, including low milk supply, painful nipples, and latching problems, as reasons for breastfeeding cessation. In addition, other factors, including lack of support or feeding advice, formula use, and returning to work, also contributed to breastfeeding cessation.
Evidence-based breastfeeding support is important for achieving breastfeeding recommendations, preventing morbidity and mortality, and promoting sustainable development goals. Thus, WHO and UNICEF have set a goal to increase breastfeeding rates to 75% in early infancy, 50% at six months, and 25% at one year of age.The Baby Friendly Hospital Initiative (BFHI) is a global program launched in 1991 by UNICEF and WHO to protect, promote and support breastfeeding in all maternity services. It requires all facilities that apply for the status of "Baby-Friendly Hospital" to provide maternity care to follow the "Ten Steps for the Successful Promotion of Breastfeeding" .
One of the 10 steps in this initiative is to have a written infant feeding policy that is routinely communicated to staff and parents. Step 2 requires the training of all healthcare staff in skills that are necessary to implement the policy. Healthcare providers play a key role in the beginning and continuity of the correct applications in breastfeeding and "Baby Friendly Hospital" criteria in society.In controlled studies, it was seen that training the nurses about BFHI principles increases their breastfeeding knowledge and practice scores and exclusive breastfeeding rates.
- Conditions
- Breastfeeding Outcomes
- Being tested
- Baby-friendly hospital initiative training program
- Keywords
- training program - breastfeeding- practices-experiences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby-friendly hospital initiative training programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: 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.
Evaluating the impact of the training program on mothers' practices regarding the baby-friendly hospital initiative principles for one group of mothers before the training and another homogenous group after conducting the program and compare between the two groups. It will measure by:
Structured Interview questionnaire will consist of two parts:
Part (1): Demographic characteristics of the mothers Part (2): Self-reported BFHI practices questionnaire: This tool will be adapted from (WHO/UNICEF, 2009) to assess the self-reported breastfeeding practices that mothers experienced during the hospital stay such as time of initiation of breastfeeding, staff assistance with positioning and attaching the baby, expression of breast milk and skin to skin contact.
Measured: 6 months
Evaluating the impact of the training program on mothers' experiences regarding breastfeeding
Evaluating the impact of the training program on mothers' experiences regarding breastfeeding for one group of mothers before the training and another homogenous group after conducting the program and compare between the two groups. It will measure by:
Mothers' breastfeeding experiences questionnaire: This tool will be adapted from (Giannì et al., 2020). It will cover four areas: breastfeeding experience, breastfeeding difficulties, breastfeeding support, and intention to breastfeed again in the following pregnancy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding OutcomesStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Salah Ali Mohamed, Mansoura University
- Investigators
- Abeer Ali, Ass.lecturer, Principal investigator, Faculty of Nursing, Mansoura University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824597
- Sponsor's protocol ID
- breastfeeding
- Acronym
- BFHI
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24277661Ducharme-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.
PubMed 33591853Shaban AS, Hassan SI, El-Nemer A. Impact of nurse-focused Baby-Friendly Hospital Initiative training program on mothers' breastfeeding practices at hospital discharge: a quasi-experimental study. BMC Pregnancy Childbirth. 2026 Apr 11;26(1):418. doi: 10.1186/s12884-026-08993-7.
PubMed 41965583
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Baby Friendly Hospital Initiative Training Program on Nurses' and Mothers' Breastfeeding Practices and Experiences
- ClinicalTrials.gov ID
- NCT06824597
- Acronym / sponsor ID
- BFHI / breastfeeding
- Conditions
- Breastfeeding Outcomes
- Keywords
- training program - breastfeeding- practices-experiences
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breastfeeding is a long-time investment in women's and babies' lives, not just a personal decision. World Health Organization (WHO) recommends breast milk as the most appropriate food for infants under six months of age. Breast milk contains all the nutrients that babies need in the first six months of life, so it is an ideal food for infants . Children who were breastfed had a lower risk of obesity and chest problems. Furthermore, breastfeeding mothers also benefited from breastfeeding, with lower rates of breast cancer, ovarian cancer, type II diabetes, and postnatal depression.
Exclusive breastfeeding (EBF) has been identified as the single most effective intervention for child survival, with the potential to prevent 13% of under-five deaths annually in low- and middle-income settings . WHO and United Nations Children's Fund (UNICEF) recommend optimal infant and young child feeding as immediate and early initiation of breastfeeding within the first hour of birth, EBF for the first 6 months of life, and with complementary feeding up to 2 years of age.
Early cessation of breastfeeding is a public health concern, especially in high-income countries, where only 25% of children were breastfeeding at 12 months of age, far below the global average of 74%. Women often cited difficulties, including low milk supply, painful nipples, and latching problems, as reasons for breastfeeding cessation. In addition, other factors, including lack of support or feeding advice, formula use, and returning to work, also contributed to breastfeeding cessation.
Evidence-based breastfeeding support is important for achieving breastfeeding recommendations, preventing morbidity and mortality, and promoting sustainable development goals. Thus, WHO and UNICEF have set a goal to increase breastfeeding rates to 75% in early infancy, 50% at six months, and 25% at one year of age.The Baby Friendly Hospital Initiative (BFHI) is a global program launched in 1991 by UNICEF and WHO to protect, promote and support breastfeeding in all maternity services. It requires all facilities that apply for the status of "Baby-Friendly Hospital" to provide maternity care to follow the "Ten Steps for the Successful Promotion of Breastfeeding" .
One of the 10 steps in this initiative is to have a written infant feeding policy that is routinely communicated to staff and parents. Step 2 requires the training of all healthcare staff in skills that are necessary to implement the policy. Healthcare providers play a key role in the beginning and continuity of the correct applications in breastfeeding and "Baby Friendly Hospital" criteria in society.In controlled studies, it was seen that training the nurses about BFHI principles increases their breastfeeding knowledge and practice scores and exclusive breastfeeding rates.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| training program for nurses | Experimental | Behavioral: Baby-friendly hospital initiative training programThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
- Who had the intention to breastfeed.
- Primiparous women
- Age between 18 and 35 years.
- Who had given birth to a singleton baby.
Key exclusion criteria (6 listed)
- Breastfeeding mothers will be excluded from the study if their baby had:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baby-friendly hospital initiative training programThe 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 | Behavioural | training program for nurses |
Primary outcome
Evaluating the nurses' experiences regarding baby-friendly hospital initiative training program
Time frame: 3 months
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.
Evaluating the nurses' practices regarding BFHI principles
Time frame: 3 months
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%.
2 secondary outcomes
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.
Time frame: 6 months
Evaluating the impact of the training program on mothers' experiences regarding breastfeeding
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Background: PubMed 24277661Hawkins 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.
- Background: PubMed 33591853Ducharme-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.
- Derived from this study: PubMed 41965583Shaban AS, Hassan SI, El-Nemer A. Impact of nurse-focused Baby-Friendly Hospital Initiative training program on mothers' breastfeeding practices at hospital discharge: a quasi-experimental study. BMC Pregnancy Childbirth. 2026 Apr 11;26(1):418. doi: 10.1186/s12884-026-08993-7.
- Baby-friendly hospital initiative: revised, updated and expanded for integrated care. Section 4, Hospital self-appraisal and monitoringLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samia Othman, professor contact
Abeer Ali, Ass.lecturer principal investigator
Faculty of Nursing, Mansoura University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby-friendly hospital initiative training program in people with Breastfeeding Outcomes, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abeer Sa Ali, Ass.lecturer (+201097536907, dr_abeer_salah@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the nurses' experiences regarding baby-friendly hospital initiative training program (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06824597, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.