Laid-back Breastfeeding in Hospital Setting
Condition: Breastfeeding
Study type: Interventional

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.
    

Intervention name(s): Laid-back breastfeeding; Standard care
Intervention type(s): Other; Other
Intervention description(s): 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; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label, randomized parallel controlled trial
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Breastfeeding; Laid-back position; Breast problems; Exclusive breastfeeding