BreastfeedingNCT03503500
Laid-back Breastfeeding in Hospital Setting
A study testing Laid-back breastfeeding in people with Breastfeeding, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
The so-called biological nurturing (BN) - or laid-back breastfeeding (LB BF), a new neurobehavioral approach to breastfeeding (BF), has the potential to enhance BF initiation and to reduce breast problems (pain, fissures, etc.), while easing the newborn attachment to the breast. Read more about this study
- Who is it for?
- Ages 15 to 55 years, women only
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Laid-back breastfeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteItaly
- Study dates
- 28 Mar 2018to 6 Dec 2018
- 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 15 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- women who plan to give birth at the Institute for Maternal and Child Health Burlo Garofolo, Trieste, and who express the intention to breastfeed, identified during the visit for their 3rd routine antenatal ultrasound scan (30/32 weeks gestational age).
Who cannot join
- presence of problems with potential negative impact on BF (e.g. severe cardiovascular problems, severe obesity as defined by body mass index above 32; hypertensive disorders);
- antenatal diagnosis of foetal complex diseases (i.e., congenital pulmonary adenomatoid malformation);
- twin pregnancy. The need for admission at birth or during hospital stay to Intensive Care Unit of both newborn or mother and the appearance of pathological jaundice in newborn are reasons for exclusion after randomization.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute for Maternal and Child Health IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, 34137
About this study
Official title: Effectiveness of a Laid-back Breastfeeding Approach on Breastfeeding Initiation in Hospital Setting. A Randomized Controlled Trial
The so-called biological nurturing (BN) - or laid-back breastfeeding (LB BF), a new neurobehavioral approach to breastfeeding (BF), has the potential to enhance BF initiation and to reduce breast problems (pain, fissures, etc.), while easing the newborn attachment to the breast. BN focuses on facilitating the mother to breastfeed in a relaxed, laid-back position, with her baby laying prone on her, so that the baby's body is in the largest possible contact with mother's curves. This position opens up the mother's body and promotes baby's movements through the activation of 20 primary neonatal reflexes stimulating BF. Neurophysiological studies show that, through this approach, infants instinctively know how to feed, thanks to the presence of neonatal reflexes, at the same time mothers being able to instinctively activate the same reflexes.
The main objective of this study is to assess the effectiveness of LB BF compared to standard hospital practices on the frequency of breast problems (i.e., pain, fissures, etc.) at discharge.
Read the detailed description
Despite the fact that breastfeeding (BF) benefits are largely known and that this practice is highly recommended, available data at national and international level show that exclusive breastfeeding rates are still low. Among the main determinants that can be addressed to improve BF prevalence, the quality of care and the support provided by health staff to women during labour and delivery seem to have a particular relevance. In hospital settings, an adequate support to women initiating BF is not always granted, especially where time availability of staff is limited and their specific skills inadequate.
In most recent years, a growing scientific evidence on neonatal primary reflexes opened new windows of intervention. In particular, the so-called biological nurturing (BN) - or laid-back breastfeeding (LB BF) - has the potential to enhance BF initiation and to reduce breast problems (pain, fissures, etc.), while easing the newborn attachment to the breast. BN is a new neurobehavioral approach to BF initiation, which focuses on facilitating the mother to breastfeed in a relaxed, laid-back position, with her baby laying prone on her, so that the baby's body is in the largest possible contact with mother's curves. This position opens up the mother's body and promotes baby's movements through the activation of 20 primary neonatal reflexes stimulating BF. Neurophysiological studies show that, through this approach, infants instinctively know how to feed, thanks to the presence of neonatal reflexes, at the same time mothers being able to instinctively activate the same reflexes.
The method is simple, given that there are no "correct" positions nor the need to follow particular procedures to BF, whilst with the traditional approach precise indications on the right BF position and attachment are to be provided to and followed by the woman. The effectiveness of BN has however not been adequately studied through randomized controlled trials, particularly in hospital settings.
The main objective of this study is to assess the effectiveness of LB BF compared to standard hospital practices on the frequency of breast problems (i.e., pain, fissures, etc.) at discharge. Secondary study objectives are to assess the effectiveness of the intervention on: exclusive breastfeeding at discharge and during the maternity ward stay; exclusive breastfeeding at 7 days and 1 and 4 months of life; frequency of breast problems at 7 days and 1 and 4 months of life; frequency of use of nipple shield at discharge, at 7 days, and at 1 and 4 months. Furthermore, the study will assess the feasibility of the LB BF approach in hospital setting and the degree of mother satisfaction.
- Conditions
- Breastfeeding
- Being tested
- Laid-back breastfeeding, Standard care
- Keywords
- Breastfeeding, Laid-back position, Breast problems, Exclusive breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laid-back breastfeedingOther
At randomization the Italian version of the video "Biological nurturing", which provides detailed information on LB BF, will be delivered to women with the recommendation to watch it before birth; during the maternity ward stay, adequately trained staff will support women to breastfed in relaxed, laid-back position, with her baby laying prone on her, so that the baby's body is in the largest possible contact with mother's curves. In the maternity ward a daily supervision by an external expert on LB BF will be provided
Standard careOther
- the standard care in use at the Institute (WHO/UNICEF 20-hours course) (control group). At randomization, the Italian version of the video "Breast is best" (Allattare informati), which provides detailed information on standard support to breastfeeding, will be delivered to women with the recommendation to watch it before birth; during the maternity ward stay, the staff will show to mothers how to breastfeed and will help them to attach the baby correctly to the breast
| Study group | Role | What they receive |
|---|---|---|
| Laid-back breastfeeding | Experimental | Women will breastfed in relaxed, laid-back position, with her baby laying prone on her, so that the baby's body is in the largest possible contact with mother's curves, without following particular procedure to breastfed. Receives: Other: Laid-back breastfeeding |
| Standard care | Active comparator | Staff will show to mothers how to breastfeed and will help them to attach the baby correctly to the breast, Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast problems
Frequency of breast problems (i.e., pain, fissures, etc.) during the hospital stay
Measured: Within 7 days of birth, at discharge from hospital
Secondary outcomes (16)
Breast problems
Frequency of breast problems (i.e., pain, fissures, etc.)
Measured: 7 days after discharge from hospital
Breast problems
Frequency of breast problems (i.e., pain, fissures, etc.)
Measured: 30 days after discharge from hospital
Breast problems
Frequency of breast problems (i.e., pain, fissures, etc.)
Measured: 120 days after discharge from hospital
Exclusive breastfeeding during the hospital stay
Frequency of exclusive breastfeeding (according to the World Health Organization definitions) during the hospital stay
Measured: Within 7 days of birth, at discharge from hospital
Exclusive breastfeeding in the last 24 hours of hospital stay
Frequency of exclusive breastfeeding (according to the World Health Organization definitions) in the last 24 hours of hospital stay
Measured: Within 7 days of birth, at discharge from hospital
Exclusive breastfeeding
Frequency of exclusive breastfeeding (according to the World Health Organization definitions)
Measured: 7 days after discharge from hospital
Exclusive breastfeeding
Frequency of exclusive breastfeeding (according to the World Health Organization definitions)
Measured: 30 days after discharge from hospital
Exclusive breastfeeding
Frequency of exclusive breastfeeding (according to the World Health Organization definitions)
Measured: 120 days after discharge from hospital
Use of nipple shield
Frequency of use of nipple shield
Measured: Within 7 days of birth, at discharge from hospital
Use of nipple shield
Frequency of use of nipple shield
Measured: 7 days after discharge from hospital
Use of nipple shield
Frequency of use of nipple shield
Measured: 30 days after discharge from hospital
Use of nipple shield
Frequency of use of nipple shield
Measured: 120 days after discharge from hospital
Mother satisfaction
Degree of maternal satisfaction evaluated using the specific subscale of the Maternal Breastfeeding Evaluation Scale (MBFES). MBFES is a 30 item scale that measures the mother's evaluation of breastfeeding, with answers given on a 5 point Likert scale (1=strongly disagree to 5=strongly agree). For the purpose of this study, only the Maternal Enjoyment/Role Attainment Subscale (questions 1, 2, 6, 9, 11, 12, 16, 17, 18, 20, 21, 23, 25, and 30) will be used
Measured: Within 7 days of birth, at discharge from hospital
Mother satisfaction
Degree of maternal satisfaction evaluated using the specific subscale of the Maternal Breastfeeding Evaluation Scale (MBFES). MBFES is a 30 item scale that measures the mother's evaluation of breastfeeding, with answers given on a 5 point Likert scale (1=strongly disagree to 5=strongly agree). For the purpose of this study, only the Maternal Enjoyment/Role Attainment Subscale (questions 1, 2, 6, 9, 11, 12, 16, 17, 18, 20, 21, 23, 25, and 30) will be used
Measured: 30 days after discharge from hospital
Mother satisfaction
Degree of maternal satisfaction evaluated using the specific subscale of the Maternal Breastfeeding Evaluation Scale (MBFES). MBFES is a 30 item scale that measures the mother's evaluation of breastfeeding, with answers given on a 5 point Likert scale (1=strongly disagree to 5=strongly agree). For the purpose of this study, only the Maternal Enjoyment/Role Attainment Subscale (questions 1, 2, 6, 9, 11, 12, 16, 17, 18, 20, 21, 23, 25, and 30) will be used
Measured: 120 days after discharge from hospital
Feasibility of the LB BF approach in hospital setting
Frequency of women who do not consent to participate or who withdraw from the study or who crossover between groups or who receive a different intervention from that allocated
Measured: Within 7 days of birth, at discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start28 Mar 2018
- Primary completion14 Aug 2018
- Study completion6 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- 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
- Open label, randomized parallel controlled trial
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Ronfani, MD, Study director, IRCCS Burlo Garofolo, Trieste, ItalyMariarosa Milinco, BF counselor, Principal investigator, IRCCS Burlo Garofolo, Trieste, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503500
- Sponsor's protocol ID
- RC 29/17
- Status last verified
- Jun 2020
- First submitted
- 28 Mar 2018
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Milinco M, Travan L, Cattaneo A, Knowles A, Sola MV, Causin E, Cortivo C, Degrassi M, Di Tommaso F, Verardi G, Dipietro L, Piazza M, Scolz S, Rossetto M, Ronfani L; Trieste BN (Biological Nurturing) Investigators. Effectiveness of biological nurturing on early breastfeeding problems: a randomized controlled trial. Int Breastfeed J. 2020 Apr 5;15(1):21. doi: 10.1186/s13006-020-00261-4.
PubMed 32248838
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Laid-back Breastfeeding Approach on Breastfeeding Initiation in Hospital Setting. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03503500
- Acronym / sponsor ID
- RC 29/17
- Conditions
- Breastfeeding
- Keywords
- Breastfeeding, Laid-back position, Breast problems, Exclusive breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 14 Aug 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 19 Apr 2018 (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.
The so-called biological nurturing (BN) - or laid-back breastfeeding (LB BF), a new neurobehavioral approach to breastfeeding (BF), has the potential to enhance BF initiation and to reduce breast problems (pain, fissures, etc.), while easing the newborn attachment to the breast. BN focuses on facilitating the mother to breastfeed in a relaxed, laid-back position, with her baby laying prone on her, so that the baby's body is in the largest possible contact with mother's curves. This position opens up the mother's body and promotes baby's movements through the activation of 20 primary neonatal reflexes stimulating BF. Neurophysiological studies show that, through this approach, infants instinctively know how to feed, thanks to the presence of neonatal reflexes, at the same time mothers being able to instinctively activate the same reflexes.
The main objective of this study is to assess the effectiveness of LB BF compared to standard hospital practices on the frequency of breast problems (i.e., pain, fissures, etc.) at discharge.
Detailed description
Despite the fact that breastfeeding (BF) benefits are largely known and that this practice is highly recommended, available data at national and international level show that exclusive breastfeeding rates are still low. Among the main determinants that can be addressed to improve BF prevalence, the quality of care and the support provided by health staff to women during labour and delivery seem to have a particular relevance. In hospital settings, an adequate support to women initiating BF is not always granted, especially where time availability of staff is limited and their specific skills inadequate.
In most recent years, a growing scientific evidence on neonatal primary reflexes opened new windows of intervention. In particular, the so-called biological nurturing (BN) - or laid-back breastfeeding (LB BF) - has the potential to enhance BF initiation and to reduce breast problems (pain, fissures, etc.), while easing the newborn attachment to the breast. BN is a new neurobehavioral approach to BF initiation, which focuses on facilitating the mother to breastfeed in a relaxed, laid-back position, with her baby laying prone on her, so that the baby's body is in the largest possible contact with mother's curves. This position opens up the mother's body and promotes baby's movements through the activation of 20 primary neonatal reflexes stimulating BF. Neurophysiological studies show that, through this approach, infants instinctively know how to feed, thanks to the presence of neonatal reflexes, at the same time mothers being able to instinctively activate the same reflexes.
The method is simple, given that there are no "correct" positions nor the need to follow particular procedures to BF, whilst with the traditional approach precise indications on the right BF position and attachment are to be provided to and followed by the woman. The effectiveness of BN has however not been adequately studied through randomized controlled trials, particularly in hospital settings.
The main objective of this study is to assess the effectiveness of LB BF compared to standard hospital practices on the frequency of breast problems (i.e., pain, fissures, etc.) at discharge. Secondary study objectives are to assess the effectiveness of the intervention on: exclusive breastfeeding at discharge and during the maternity ward stay; exclusive breastfeeding at 7 days and 1 and 4 months of life; frequency of breast problems at 7 days and 1 and 4 months of life; frequency of use of nipple shield at discharge, at 7 days, and at 1 and 4 months. Furthermore, the study will assess the feasibility of the LB BF approach in hospital setting and the degree of mother satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, randomized parallel controlled trial
| Arm | Type | Receives |
|---|---|---|
| Laid-back breastfeeding | Experimental | Other: Laid-back breastfeedingWomen will breastfed in relaxed, laid-back position, with her baby laying prone on her, so that the baby's body is in the largest possible contact with mother's curves, without following particular procedure to breastfed. |
| Standard care | Active comparator | Other: Standard careStaff will show to mothers how to breastfeed and will help them to attach the baby correctly to the breast, |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- women who plan to give birth at the Institute for Maternal and Child Health Burlo Garofolo, Trieste, and who express the intention to breastfeed, identified during the visit for their 3rd routine antenatal ultrasound scan (30/32 weeks gestational age).
Key exclusion criteria (3 listed)
- presence of problems with potential negative impact on BF (e.g. severe cardiovascular problems, severe obesity as defined by body mass index above 32; hypertensive disorders);
- antenatal diagnosis of foetal complex diseases (i.e., congenital pulmonary adenomatoid malformation);
- twin pregnancy. The need for admission at birth or during hospital stay to Intensive Care Unit of both newborn or mother and the appearance of pathological jaundice in newborn are reasons for exclusion after randomization.
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 |
|---|---|---|
| Laid-back breastfeedingAt randomization the Italian version of the video "Biological nurturing", which provides detailed information on LB BF, will be delivered to women with the recommendation to watch it before birth; during the maternity ward stay, adequately trained staff will support women to breastfed in relaxed, laid-back position, with her baby laying prone on her, so that the baby's body is in the largest possible contact with mother's curves. In the maternity ward a daily supervision by an external expert on LB BF will be provided | Other | Laid-back breastfeeding |
| Standard care2. the standard care in use at the Institute (WHO/UNICEF 20-hours course) (control group). At randomization, the Italian version of the video "Breast is best" (Allattare informati), which provides detailed information on standard support to breastfeeding, will be delivered to women with the recommendation to watch it before birth; during the maternity ward stay, the staff will show to mothers how to breastfeed and will help them to attach the baby correctly to the breast | Other | Standard care |
Primary outcome
Breast problems
Time frame: Within 7 days of birth, at discharge from hospital
Frequency of breast problems (i.e., pain, fissures, etc.) during the hospital stay
16 secondary outcomes
Breast problems
Time frame: 7 days after discharge from hospital
Breast problems
Time frame: 30 days after discharge from hospital
Breast problems
Time frame: 120 days after discharge from hospital
Exclusive breastfeeding during the hospital stay
Time frame: Within 7 days of birth, at discharge from hospital
Exclusive breastfeeding in the last 24 hours of hospital stay
Time frame: Within 7 days of birth, at discharge from hospital
Exclusive breastfeeding
Time frame: 7 days after discharge from hospital
Exclusive breastfeeding
Time frame: 30 days after discharge from hospital
Exclusive breastfeeding
Time frame: 120 days after discharge from hospital
Use of nipple shield
Time frame: Within 7 days of birth, at discharge from hospital
Use of nipple shield
Time frame: 7 days after discharge from hospital
Use of nipple shield
Time frame: 30 days after discharge from hospital
Use of nipple shield
Time frame: 120 days after discharge from hospital
Mother satisfaction
Time frame: Within 7 days of birth, at discharge from hospital
Mother satisfaction
Time frame: 30 days after discharge from hospital
Mother satisfaction
Time frame: 120 days after discharge from hospital
Feasibility of the LB BF approach in hospital setting
Time frame: Within 7 days of birth, at discharge from hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Results publication: PubMed 32248838Milinco M, Travan L, Cattaneo A, Knowles A, Sola MV, Causin E, Cortivo C, Degrassi M, Di Tommaso F, Verardi G, Dipietro L, Piazza M, Scolz S, Rossetto M, Ronfani L; Trieste BN (Biological Nurturing) Investigators. Effectiveness of biological nurturing on early breastfeeding problems: a randomized controlled trial. Int Breastfeed J. 2020 Apr 5;15(1):21. doi: 10.1186/s13006-020-00261-4.
- Individual participant dataSharing planned: No
Related trials for Breastfeeding
RecruitingObservational study
A Global Prospective Observational Study of Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding
Fabry Disease
Enrolling by invitation
The Effect of Breastfeeding Education Delivered Via a Hybrid Model on Breastfeeding Efficacy and Postpartum Comfort Levels
Breastfeeding, Postpartum Comfort
Not yet recruiting
Effect of a Breastfeeding Chatbot on Mothers' Breastfeeding Attitudes, Behaviors, and Self-Efficacy
Breastfeeding, Breastfeeding Attitudes
Not yet recruiting
THE EFFECT OF A VIRTUAL REALITY BREASTFEEDING EXPERIENCE ON BREASTFEEDING EXPECTATIONS AND AVOIDANCE
Breastfeeding Expectations, Breastfeeding Avoidance
Recruiting
Effect of Solution-Focused Approach Education on Breastfeeding Avoidance and Breastfeeding Self-Efficacy in Primiparous Mothers
Breastfeeding Avoidance and Breastfeeding Self-efficacy
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.
Luca Ronfani, MD study director
IRCCS Burlo Garofolo, Trieste, Italy
Mariarosa Milinco, BF counselor principal investigator
IRCCS Burlo Garofolo, Trieste, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laid-back breastfeeding in people with Breastfeeding, run by IRCCS Burlo Garofolo at 1 site in Italy.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 22 Jun 2020. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast problems (time frame: Within 7 days of birth, at discharge from hospital). 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 NCT03503500, which also lists 1 linked publication.
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 22 Jun 2020.