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Laid-back Breastfeeding in Hospital Setting

NCT03503500 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2020-06-22

No results posted yet for this study

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.

Conditions

  • Breastfeeding

Interventions

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

OTHER

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

Sponsors & Collaborators

  • IRCCS Burlo Garofolo

    lead OTHER

Principal Investigators

  • Luca Ronfani, MD · IRCCS Burlo Garofolo, Trieste, Italy

  • Mariarosa Milinco, BF counselor · IRCCS Burlo Garofolo, Trieste, Italy

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-28
Primary Completion
2018-08-14
Completion
2018-12-06

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03503500 on ClinicalTrials.gov