Clinical trial NCT03503500: Laid-back Breastfeeding in Hospital Setting
Official title: Effectiveness of a Laid-back Breastfeeding Approach on Breastfeeding Initiation in Hospital Setting. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: Breastfeeding
Laid-back position
Breast problems
Exclusive breastfeeding
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2018-04-19
Enrollment: 208
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label, randomized parallel controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Breast problems
timeFrame: Within 7 days of birth, at discharge from hospital
Secondary outcomes:
measure: Breast problems
timeFrame: 7 days after discharge from hospital
measure: Breast problems
timeFrame: 30 days after discharge from hospital
measure: Breast problems
timeFrame: 120 days after discharge from hospital
measure: Exclusive breastfeeding during the hospital stay
timeFrame: Within 7 days of birth, at discharge from hospital
measure: Exclusive breastfeeding in the last 24 hours of hospital stay
timeFrame: Within 7 days of birth, at discharge from hospital
measure: Exclusive breastfeeding
timeFrame: 7 days after discharge from hospital
measure: Exclusive breastfeeding
timeFrame: 30 days after discharge from hospital
measure: Exclusive breastfeeding
timeFrame: 120 days after discharge from hospital
measure: Use of nipple shield
timeFrame: Within 7 days of birth, at discharge from hospital
measure: Use of nipple shield
timeFrame: 7 days after discharge from hospital
measure: Use of nipple shield
timeFrame: 30 days after discharge from hospital
measure: Use of nipple shield
timeFrame: 120 days after discharge from hospital
measure: Mother satisfaction
timeFrame: Within 7 days of birth, at discharge from hospital
measure: Mother satisfaction
timeFrame: 30 days after discharge from hospital
measure: Mother satisfaction
timeFrame: 120 days after discharge from hospital
measure: Feasibility of the LB BF approach in hospital setting
timeFrame: Within 7 days of birth, at discharge from hospital
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health IRCCS Burlo Garofolo
state: Friuli Venezia Giulia
Study officials:
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
name: Luca Ronfani, MD
role: STUDY_DIRECTOR
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
name: Mariarosa Milinco, BF counselor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.