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Laid-back Breastfeeding in Hospital Setting

Effectiveness of a Laid-back Breastfeeding Approach on Breastfeeding Initiation in Hospital Setting. A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03503500
Enrollment
208
Registered
2018-04-19
Start date
2018-03-28
Completion date
2018-12-06
Last updated
2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding

Keywords

Breastfeeding, Laid-back position, Breast problems, Exclusive breastfeeding

Brief 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. 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.

Interventions

OTHERLaid-back breastfeeding

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

OTHERStandard care

2\. 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

Sponsors

IRCCS Burlo Garofolo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Open label, randomized parallel controlled trial

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Breast problemsWithin 7 days of birth, at discharge from hospitalFrequency of breast problems (i.e., pain, fissures, etc.) during the hospital stay

Secondary

MeasureTime frameDescription
Exclusive breastfeeding during the hospital stayWithin 7 days of birth, at discharge from hospitalFrequency of exclusive breastfeeding (according to the World Health Organization definitions) during the hospital stay
Exclusive breastfeeding in the last 24 hours of hospital stayWithin 7 days of birth, at discharge from hospitalFrequency of exclusive breastfeeding (according to the World Health Organization definitions) in the last 24 hours of hospital stay
Exclusive breastfeeding7 days after discharge from hospitalFrequency of exclusive breastfeeding (according to the World Health Organization definitions)
Breast problems7 days after discharge from hospitalFrequency of breast problems (i.e., pain, fissures, etc.)
Mother satisfactionWithin 7 days of birth, at discharge from hospitalDegree 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
Feasibility of the LB BF approach in hospital settingWithin 7 days of birth, at discharge from hospitalFrequency 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
Use of nipple shieldWithin 7 days of birth, at discharge from hospitalFrequency of use of nipple shield

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026