Laid-back Breastfeeding in Hospital Setting

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503500
• Other study ID #: RC 29/17
• Status: Completed
• Phase: N/A
• Start date: March 28, 2018
• Est. completion date: December 6, 2018

Study information

• Verified date: June 2020
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: December 6, 2018
• Est. primary completion date: August 14, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Other:
• Laid-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
• Standard 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

Locations

Country	Name	City	State
Italy	Institute for Maternal and Child Health IRCCS Burlo Garofolo	Trieste	Friuli Venezia Giulia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast problems	Frequency of breast problems (i.e., pain, fissures, etc.) during the hospital stay	Within 7 days of birth, at discharge from hospital
Secondary	Breast problems	Frequency of breast problems (i.e., pain, fissures, etc.)	7 days after discharge from hospital
Secondary	Breast problems	Frequency of breast problems (i.e., pain, fissures, etc.)	30 days after discharge from hospital
Secondary	Breast problems	Frequency of breast problems (i.e., pain, fissures, etc.)	120 days after discharge from hospital
Secondary	Exclusive breastfeeding during the hospital stay	Frequency of exclusive breastfeeding (according to the World Health Organization definitions) during the hospital stay	Within 7 days of birth, at discharge from hospital
Secondary	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	Within 7 days of birth, at discharge from hospital
Secondary	Exclusive breastfeeding	Frequency of exclusive breastfeeding (according to the World Health Organization definitions)	7 days after discharge from hospital
Secondary	Exclusive breastfeeding	Frequency of exclusive breastfeeding (according to the World Health Organization definitions)	30 days after discharge from hospital
Secondary	Exclusive breastfeeding	Frequency of exclusive breastfeeding (according to the World Health Organization definitions)	120 days after discharge from hospital
Secondary	Use of nipple shield	Frequency of use of nipple shield	Within 7 days of birth, at discharge from hospital
Secondary	Use of nipple shield	Frequency of use of nipple shield	7 days after discharge from hospital
Secondary	Use of nipple shield	Frequency of use of nipple shield	30 days after discharge from hospital
Secondary	Use of nipple shield	Frequency of use of nipple shield	120 days after discharge from hospital
Secondary	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	Within 7 days of birth, at discharge from hospital
Secondary	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	30 days after discharge from hospital
Secondary	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	120 days after discharge from hospital
Secondary	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	Within 7 days of birth, at discharge from hospital