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Laid-back Breastfeeding in Hospital Setting

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ClinicalTrials.gov Identifier: NCT03503500
Recruitment Status : Completed
First Posted : April 19, 2018
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
IRCCS Burlo Garofolo

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.


Condition or disease Intervention/treatment Phase
Breastfeeding Other: Laid-back breastfeeding Other: Standard care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open label, randomized parallel controlled trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of a Laid-back Breastfeeding Approach on Breastfeeding Initiation in Hospital Setting. A Randomized Controlled Trial
Actual Study Start Date : March 28, 2018
Actual Primary Completion Date : August 14, 2018
Actual Study Completion Date : December 6, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Laid-back breastfeeding
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
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

Active Comparator: Standard care
Staff will show to mothers how to breastfeed and will help them to attach the baby correctly to the breast,
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




Primary Outcome Measures :
  1. Breast problems [ Time Frame: Within 7 days of birth, at discharge from hospital ]
    Frequency of breast problems (i.e., pain, fissures, etc.) during the hospital stay


Secondary Outcome Measures :
  1. Breast problems [ Time Frame: 7 days after discharge from hospital ]
    Frequency of breast problems (i.e., pain, fissures, etc.)

  2. Breast problems [ Time Frame: 30 days after discharge from hospital ]
    Frequency of breast problems (i.e., pain, fissures, etc.)

  3. Breast problems [ Time Frame: 120 days after discharge from hospital ]
    Frequency of breast problems (i.e., pain, fissures, etc.)

  4. Exclusive breastfeeding during the hospital stay [ Time Frame: Within 7 days of birth, at discharge from hospital ]
    Frequency of exclusive breastfeeding (according to the World Health Organization definitions) during the hospital stay

  5. Exclusive breastfeeding in the last 24 hours of hospital stay [ Time Frame: Within 7 days of birth, at discharge from hospital ]
    Frequency of exclusive breastfeeding (according to the World Health Organization definitions) in the last 24 hours of hospital stay

  6. Exclusive breastfeeding [ Time Frame: 7 days after discharge from hospital ]
    Frequency of exclusive breastfeeding (according to the World Health Organization definitions)

  7. Exclusive breastfeeding [ Time Frame: 30 days after discharge from hospital ]
    Frequency of exclusive breastfeeding (according to the World Health Organization definitions)

  8. Exclusive breastfeeding [ Time Frame: 120 days after discharge from hospital ]
    Frequency of exclusive breastfeeding (according to the World Health Organization definitions)

  9. Use of nipple shield [ Time Frame: Within 7 days of birth, at discharge from hospital ]
    Frequency of use of nipple shield

  10. Use of nipple shield [ Time Frame: 7 days after discharge from hospital ]
    Frequency of use of nipple shield

  11. Use of nipple shield [ Time Frame: 30 days after discharge from hospital ]
    Frequency of use of nipple shield

  12. Use of nipple shield [ Time Frame: 120 days after discharge from hospital ]
    Frequency of use of nipple shield

  13. Mother satisfaction [ Time Frame: Within 7 days of birth, at discharge from hospital ]
    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

  14. Mother satisfaction [ Time Frame: 30 days after discharge from hospital ]
    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

  15. Mother satisfaction [ Time Frame: 120 days after discharge from hospital ]
    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

  16. Feasibility of the LB BF approach in hospital setting [ Time Frame: Within 7 days of birth, at discharge from hospital ]
    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



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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503500


Locations
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Italy
Institute for Maternal and Child Health IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, Italy, 34137
Sponsors and Collaborators
IRCCS Burlo Garofolo
Investigators
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Study Director: Luca Ronfani, MD IRCCS Burlo Garofolo, Trieste, Italy
Principal Investigator: Mariarosa Milinco, BF counselor IRCCS Burlo Garofolo, Trieste, Italy
Publications of Results:
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Responsible Party: IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT03503500    
Other Study ID Numbers: RC 29/17
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IRCCS Burlo Garofolo:
Breastfeeding
Laid-back position
Breast problems
Exclusive breastfeeding