Breast FeedingNCT05059574
Breast Crawling,Breastfeeding Success and Mothers' Attitudes to Feeding Their Babies
A study testing Breast Crawling in people with Breast Feeding and Feeding Behavior, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
It has been clearly demonstrated by the literature that the way of initiation of breastfeeding is highly correlated with the success and continuation of breastfeeding and the level of breastfeeding intention. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Feeding Behavior
- What is being tested?
- Breast Crawling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteer to participate in the research,
- Vaginal birth,
- Over 18 years old,
- Able to read and write
- Can speak Turkish,
- Having a full-term and healthy birth (38-42 weeks old, born 2500-4000gr, born with a 5th minute apgar of 7 and above, no known congenital disease),
- Does not have a disease that prevents breastfeeding
Who cannot join
- Not voluntarily to participate in the research,
- Cesarean delivery,
- Having a health problem in which the mother or baby is at risk,
- Those who have a disease that prevents breastfeeding.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University
Sakarya, 54050
Kevser Özdemir, Dr, +90 264 295 66 24, kevserozdemir@sakarya.edu.tr
Kevser Çimen, 90 534 944 31 96, kvsrcmn1@gmail.com
About this study
Official title: The Effect of Breast Crawling After Vaginal Delivery on Breastfeeding Success and Mothers' Attitudes to Feeding Their Babies
It has been clearly demonstrated by the literature that the way of initiation of breastfeeding is highly correlated with the success and continuation of breastfeeding and the level of breastfeeding intention. Crawling to the breast is the reflex of seeking the breast by smelling the breastmilk of the newborn as the first form of breastfeeding. Although crawling to the breast is a studied subject in the international literature, it has remained only in the compilation stage in the national literature. The fact that research on breast crawling has not yet been conducted in our country constitutes the original value of this study. This study was planned to examine the effect of crawling to the breast after vaginal delivery compared to biological breastfeeding on breastfeeding success and mothers' attitude to feed their babies.
Read the detailed description
Breastfeeding is one of the most effective ways to ensure child health and survival. Breast milk is the ideal food for babies. It is safe and clean. It contains antibodies that help protect against many common childhood diseases. Breast milk provides all the energy and nutrients a baby needs in the first months of life. However, about 2 out of 3 babies cannot be exclusively breastfed for the recommended 6 months.
WHO and UNICEF,
- early start of breastfeeding within 1 hour after birth,
- exclusive breastfeeding for the first 6 months of life
- Providing nutritionally sufficient and safe complementary (solid) foods in the 6th month, It recommends continuing breastfeeding up to 2 years of age. Early initiation of breastfeeding within 1 hour after birth protects the newborn from infection and reduces neonatal mortality. However, many infants and children do not receive optimal nutrition. For example, only about 44% of infants aged 0-6 months worldwide were exclusively breastfed during the 2015-2020 period.
Breastfeeding Success The most important reason for breastfeeding failure is the inability to start breastfeeding. For this reason, it is necessary to provide the necessary comfort of the mother in order to ensure breastfeeding success. In order to initiate and maintain a successful breastfeeding, mothers should be educated about being physically and mentally healthy, have a balanced diet, and be able to give breast milk with the right technique during pregnancy and the period following birth. Many mothers need help, especially when starting to breastfeed their first baby. A good start to breastfeeding affects the mother's determination to continue breastfeeding. However, difficulties encountered in breastfeeding during this period may lead to anxiety, causing mothers to lose their self-confidence and thus to a decrease in breastfeeding. Therefore, if the mother and baby are suitable, it is very important to initiate the first breastfeeding in this period called the 1st Stage (1st Reactive Period) after the birth.
Odent talked about the ability of a newborn to search for the breast for "that important first sucking action" within the first hour of opening his eyes to the world and to use the search reflex to find it. Widström et al. Crawling to the breast is defined as an organized, spontaneous behavior sequence of newborns to seek and move towards the nipple and initiate breastfeeding. In order to find the breast, newborns first use the stepping reflex to climb into the mother's belly, and then the search reflex to find the nipple, catch and suck. This is called newborn attachment or crawling to the breast. They stated that this behavior of the newborn can be observed in its most intact form within the first few hours of its birth.
The study was planned as a randomized controlled and experimental study in order to evaluate the effect of crawling on the breast after vaginal delivery on breastfeeding success and mothers' attitude to feed their babies.
Women who had vaginal delivery between October 2021 and April 2022 in the delivery room of S.B.Ü Darıca Farabi Training and Research Hospital will be included in the study.
The population of the research will be women who gave vaginal birth in the delivery room of S.B.Ü Darıca Farabi Training and Research Hospital between T October 2021 and April 2022, and the sample will be 68 women (34 control/34 experiment-intervention).
- Conditions
- Breast Feeding, Feeding Behavior
- Being tested
- Breast Crawling
- Keywords
- Breast Crawling, Vaginal Delivery, Breastfeeding Success
- Medical subject headings
- Breast Feeding, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast CrawlingBehavioural
The mother's first breast-feeding of her baby is not routine biological breast-feeding, but as a cradle to the breast.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Mothers in this group will begin their baby's first breastfeeding by crawling to the breast. Receives: Behavioral: Breast Crawling |
| Control group | No intervention | Mothers in this group will begin their baby's first breastfeeding with biological breastfeeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding success measurement
Determining the success of breastfeeding by getting a higher score on the LATCH Breastfeeding Diagnostic Scale in the experimental group, in which the first breast-feeding was applied by crawling to the breast compared to the control group.
Measured: 2 years
Measuring mothers' feeding attitudes of their babies
In the experimental group in which the first breast-feeding was applied by crawling to the breast, the mothers' milk feeding behavior increased by getting a higher score on the "The Iowa Infant Feeding Attitude Scale" compared to the control group.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Jun 2022 (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 Breast FeedingStudies of the same condition, open and under way.
- More trials run by Sakarya 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- While crawling to the breast is tried in the experimental group, biological breastfeeding will be applied in the control group.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kevser Ozdemir, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059574
- Sponsor's protocol ID
- 13092021
- Status last verified
- Sep 2021
- First submitted
- 13 Sep 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The follow-up of the study data will be provided by both researchers.
Publications
Hym C, Forma V, Anderson DI, Provasi J, Granjon L, Huet V, Carpe E, Teulier C, Durand K, Schaal B, Barbu-Roth M. Newborn crawling and rooting in response to maternal breast odor. Dev Sci. 2021 May;24(3):e13061. doi: 10.1111/desc.13061. Epub 2020 Dec 5.
PubMed 33174352Henderson A. Understanding the breast crawl: implications for nursing practice. Nurs Womens Health. 2011 Aug-Sep;15(4):296-307. doi: 10.1111/j.1751-486X.2011.01650.x. No abstract available.
PubMed 21884495Heidarzadeh M, Hakimi S, Habibelahi A, Mohammadi M, Shahrak SP. Comparison of Breast Crawl Between Infants Delivered by Vaginal Delivery and Cesarean Section. Breastfeed Med. 2016 Aug;11(6):305-308. doi: 10.1089/bfm.2015.0168. Epub 2016 May 12.
PubMed 27171469
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breast Crawling After Vaginal Delivery on Breastfeeding Success and Mothers' Attitudes to Feeding Their Babies
- ClinicalTrials.gov ID
- NCT05059574
- Acronym / sponsor ID
- 13092021
- Conditions
- Breast Feeding, Feeding Behavior
- Keywords
- Breast Crawling, Vaginal Delivery, Breastfeeding Success
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 28 Sep 2021 (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.
It has been clearly demonstrated by the literature that the way of initiation of breastfeeding is highly correlated with the success and continuation of breastfeeding and the level of breastfeeding intention. Crawling to the breast is the reflex of seeking the breast by smelling the breastmilk of the newborn as the first form of breastfeeding. Although crawling to the breast is a studied subject in the international literature, it has remained only in the compilation stage in the national literature. The fact that research on breast crawling has not yet been conducted in our country constitutes the original value of this study. This study was planned to examine the effect of crawling to the breast after vaginal delivery compared to biological breastfeeding on breastfeeding success and mothers' attitude to feed their babies.
Detailed description
Breastfeeding is one of the most effective ways to ensure child health and survival. Breast milk is the ideal food for babies. It is safe and clean. It contains antibodies that help protect against many common childhood diseases. Breast milk provides all the energy and nutrients a baby needs in the first months of life. However, about 2 out of 3 babies cannot be exclusively breastfed for the recommended 6 months.
WHO and UNICEF,
- early start of breastfeeding within 1 hour after birth,
- exclusive breastfeeding for the first 6 months of life
- Providing nutritionally sufficient and safe complementary (solid) foods in the 6th month, It recommends continuing breastfeeding up to 2 years of age. Early initiation of breastfeeding within 1 hour after birth protects the newborn from infection and reduces neonatal mortality. However, many infants and children do not receive optimal nutrition. For example, only about 44% of infants aged 0-6 months worldwide were exclusively breastfed during the 2015-2020 period.
Breastfeeding Success The most important reason for breastfeeding failure is the inability to start breastfeeding. For this reason, it is necessary to provide the necessary comfort of the mother in order to ensure breastfeeding success. In order to initiate and maintain a successful breastfeeding, mothers should be educated about being physically and mentally healthy, have a balanced diet, and be able to give breast milk with the right technique during pregnancy and the period following birth. Many mothers need help, especially when starting to breastfeed their first baby. A good start to breastfeeding affects the mother's determination to continue breastfeeding. However, difficulties encountered in breastfeeding during this period may lead to anxiety, causing mothers to lose their self-confidence and thus to a decrease in breastfeeding. Therefore, if the mother and baby are suitable, it is very important to initiate the first breastfeeding in this period called the 1st Stage (1st Reactive Period) after the birth.
Odent talked about the ability of a newborn to search for the breast for "that important first sucking action" within the first hour of opening his eyes to the world and to use the search reflex to find it. Widström et al. Crawling to the breast is defined as an organized, spontaneous behavior sequence of newborns to seek and move towards the nipple and initiate breastfeeding. In order to find the breast, newborns first use the stepping reflex to climb into the mother's belly, and then the search reflex to find the nipple, catch and suck. This is called newborn attachment or crawling to the breast. They stated that this behavior of the newborn can be observed in its most intact form within the first few hours of its birth.
The study was planned as a randomized controlled and experimental study in order to evaluate the effect of crawling on the breast after vaginal delivery on breastfeeding success and mothers' attitude to feed their babies.
Women who had vaginal delivery between October 2021 and April 2022 in the delivery room of S.B.Ü Darıca Farabi Training and Research Hospital will be included in the study.
The population of the research will be women who gave vaginal birth in the delivery room of S.B.Ü Darıca Farabi Training and Research Hospital between T October 2021 and April 2022, and the sample will be 68 women (34 control/34 experiment-intervention).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- While crawling to the breast is tried in the experimental group, biological breastfeeding will be applied in the control group.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Breast CrawlingMothers in this group will begin their baby's first breastfeeding by crawling to the breast. |
| Control group | No intervention | –Mothers in this group will begin their baby's first breastfeeding with biological breastfeeding. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Volunteer to participate in the research,
- Vaginal birth,
- Over 18 years old,
- Able to read and write
- Can speak Turkish,
Key exclusion criteria (4 listed)
- Not voluntarily to participate in the research,
- Cesarean delivery,
- Having a health problem in which the mother or baby is at risk,
- Those who have a disease that prevents breastfeeding.
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 |
|---|---|---|
| Breast CrawlingThe mother's first breast-feeding of her baby is not routine biological breast-feeding, but as a cradle to the breast. | Behavioural | Experimental group |
Primary outcome
Breastfeeding success measurement
Time frame: 2 years
Determining the success of breastfeeding by getting a higher score on the LATCH Breastfeeding Diagnostic Scale in the experimental group, in which the first breast-feeding was applied by crawling to the breast compared to the control group.
Measuring mothers' feeding attitudes of their babies
Time frame: 2 years
In the experimental group in which the first breast-feeding was applied by crawling to the breast, the mothers' milk feeding behavior increased by getting a higher score on the "The Iowa Infant Feeding Attitude Scale" compared to the control group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Background: PubMed 33174352Hym C, Forma V, Anderson DI, Provasi J, Granjon L, Huet V, Carpe E, Teulier C, Durand K, Schaal B, Barbu-Roth M. Newborn crawling and rooting in response to maternal breast odor. Dev Sci. 2021 May;24(3):e13061. doi: 10.1111/desc.13061. Epub 2020 Dec 5.
- Background: PubMed 21884495Henderson A. Understanding the breast crawl: implications for nursing practice. Nurs Womens Health. 2011 Aug-Sep;15(4):296-307. doi: 10.1111/j.1751-486X.2011.01650.x. No abstract available.
- Background: PubMed 27171469Heidarzadeh M, Hakimi S, Habibelahi A, Mohammadi M, Shahrak SP. Comparison of Breast Crawl Between Infants Delivered by Vaginal Delivery and Cesarean Section. Breastfeed Med. 2016 Aug;11(6):305-308. doi: 10.1089/bfm.2015.0168. Epub 2016 May 12.
- Individual participant dataSharing planned: Yes. The follow-up of the study data will be provided by both researchers.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Crawling in people with Breast Feeding and Feeding Behavior, run by Sakarya University at 1 site in Turkey (Türkiye).
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 4 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: status not confirmed, as of the sponsor's last update on 28 Sep 2021. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevser Özdemir, Dr (+90 264 295 66 24, kevserozdemir@sakarya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding success measurement (time frame: 2 years). 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 NCT05059574, 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 28 Sep 2021.