Laid-back Breastfeeding in Hospital Setting

NCT03503500 | Completed

• 1 other identifier: RC 29/17
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Breast problems

  7 days after discharge from hospital

• Breast problems

  30 days after discharge from hospital

• Breast problems

  120 days after discharge from hospital

• Exclusive breastfeeding during the hospital stay

  Within 7 days of birth, at discharge from hospital

• Exclusive breastfeeding in the last 24 hours of hospital stay

  Within 7 days of birth, at discharge from hospital

Study Arms (2)

Laid-back breastfeeding

EXPERIMENTAL

Women will 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, without following particular procedure to breastfed.

Other: Laid-back breastfeeding

Standard care

ACTIVE COMPARATOR

Staff will show to mothers how to breastfeed and will help them to attach the baby correctly to the breast,

Other: Standard care

Interventions

Laid-back breastfeeding OTHER

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

Laid-back breastfeeding

Standard care OTHER

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

Standard care

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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);

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

Institute for Maternal and Child Health IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, 34137, Italy

Location

Related 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 early breastfeeding problems: a randomized controlled trial. Int Breastfeed J. 2020 Apr 5;15(1):21. doi: 10.1186/s13006-020-00261-4.

  PMID: 32248838 RESULT

MeSH Terms

Conditions

Breast Feeding

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Luca Ronfani, MD

  IRCCS Burlo Garofolo, Trieste, Italy

  STUDY DIRECTOR

• Mariarosa Milinco, BF counselor

  IRCCS Burlo Garofolo, Trieste, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, randomized parallel controlled trial

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 19, 2018
• Study Start: March 28, 2018
• Primary Completion: August 14, 2018
• Study Completion: December 6, 2018
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)