Cerebral Synchronization Between Mothers and Their Newborns During Breastfeeding

NCT05821569 | Unknown

• 1 other identifier: RC 53/22
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Different reciprocal positions of mother and newborn during breastfeeding may be adopted. Other than the one derived from UNICEF guidelines, or standard position, an approach called biological nurturing has been recently proposed. It aims to promote the activation of neonatal primitive reflexes, breast problems reduction (e.g. cracked or sore nipple) and, overall, spontaneity and naturalness of mother-newborn dyad behaviour during feeding. The study of newborn cortical activation by functional near-infrared spectroscopy (fNIRS), a safe and minimally invasive functional neuroimaging technique based on haemoglobin absorption of near-infrared light, showed that baby's cortex exhibit a wide activation associated with breastfeeding. Moreover, preliminary and not yet published data, collected by fNIRS hyperscanning (e.g. the simultaneous detection of brain functional activation from two individuals living the same experience) in the Nursery of our Institute, evidenced that mother-newborn dyads adopting a biological nurturing approach to breastfeeding show a neural synchronization between their frontal cortex during such experience. Basing on this new evidence, it is now worth to understand if a biological nurturing approach to breastfeeding may promote such neural synchronization, even when postpartum depressive symptoms are present. Accordingly, biological nurturing may result to be protective for the neural basis of mother-newborn relationship, also in case of a postnatal affective suffering and helping to prevent its potential long term consequences on maternal wellbeing and infant neurodevelopment as well. Moreover, since oxytocin is a neuropeptide with widespread influence on parental function, including lactation and nurturing maternal behaviour physiology, if a biological nurturing approach to breastfeeding may promote the oxytocin level in the mother and/or in the newborn is worth to understand as well, taking into account again possible relations with postpartum depression symptoms. the aim of this study is to evaluate, by fNIRS hyperscanning, if the frontal cerebral cortex functional synchronization of mother-newborn dyads, who adopt a reciprocal positioning according to the biological nurturing approach during breastfeeding, differs from that of mother-newborn dyads adopting the standard position, taking into account the intensity of mother's postpartum depressive symptoms.

Conditions

Depression, Postpartum

Keywords

Breastfeeding; Near-infrared spectroscopy; Postpartum depression

Outcome Measures

Primary Outcomes (2)

• To compare the frontal cerebral cortex functional synchronization in mother-newborn dyads adopting biological nurturing vs standard position to breastfeed

  To evaluate by fNIRS hyperscanning if the frontal cerebral cortex functional synchronization of mother-newborn dyads who adopt a reciprocal positioning according to the biological nurturing approach during breastfeeding, differs from that of mother-newborn dyads adopting the standard position. Cortical activation associated with breastfeeding will be assessed by multichannel fNIRS (Hitachi mod. ETG 4000, 48 channels), using a fibre holder in plastic in mothers and in soft material (neoprene) in newborns, with an interfibre distance of 3 cm. Bilateral functional activity in the frontal and somatomotor areas will be monitored in both mother and newborn (24 channels each).

  At the second day after birth

• To compare the presence of postpartum depressive symptoms in women adopting biological nurturing vs standard position to breastfeed

  The presence of maternal postpartum depressive symptoms will be evaluated by the Edinburgh Postnatal Depression Scale (EPDS), a set of 10 screening questions. Each answer is given a score of 0 to 3. Cut-off values of 10 or higher suggest the presence of depression.

  At the second day after birth

Secondary Outcomes (2)

• To compare the oxytocin level of mothers adopting different position during breastfeeding (standard position vs biological nursing)

  At the second day after birth

• To evaluate the oxytocin level of newborns according to different position adopted during breastfeeding (standard position vs biological nursing)

  At the second day after birth

Study Arms (2)

standard position during breastfeeding

Women who adopted, according to their preference and/or to the professional advice and support of the nursing staff the standard position (derived from UNICEF guidelines) to breastfeed

Other: Standard approach

biological nurturing

Women who adopted, according to their preference and/or to the professional advice and support of the nursing staff, the biological nurturing approach to breastfeed

Other: Biological nurturing

Interventions

Standard approach OTHER

Adoption of standard approach (derived by Unicef guidelines) to breastfeed

standard position during breastfeeding

Biological nurturing OTHER

Adoption of biological nurturing approach to breastfeed

biological nurturing

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Full term healthy newborns and their mothers.

You may qualify if:

• Full term healthy newborn
• Weight \> 2500 gr
• Vaginal delivery
• Breastfeeding already started
• Absence of breast problems (e.g. cracked or sore nipple)
• Parents' consent to research participation

You may not qualify if:

• Syndromic diagnosis (genetic/hereditary)
• Condition affecting a major organ (heart disease, cerebropathy, etc.)
• Medication intake that may interfere with the data collection (e.g. analgesics)
• Newborn head lesion that may interfere with the fNIRS assessment (e.g. due to an operative delivery)
• Mother history of neurological or neurosensory disorder, psychosis, bipolar disorder, and substance abuse or addiction.

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

IRCCS Burlo Garofolo

Trieste, 34137, Italy

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum; Breast Feeding

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Feeding Behavior; Behavior

Study Officials

• Stefano Bembich, MSC

  IRCCS materno infantile Burlo Garofolo

  STUDY DIRECTOR

Central Study Contacts

Stefano Bembich, MSC

CONTACT

+390403785111; stefano.bembich@burlo.trieste.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 20, 2023
• Study Start: January 9, 2024
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

IT (1)