Exploring mother-newborn brain synchronization during breastfeeding

Cerebral Synchronization Between Mothers and Their Newborns During Breastfeeding and Related Oxytocin Response, According to Different Reciprocal Positioning of the Dyad, and Possible Related Benefit for Postpartum Depressive Symptoms

Observational IRCCS Burlo Garofolo · NCT05821569

This study looks at how mothers' and newborns' brains work together during breastfeeding to see if a new feeding position can improve both the mother's mental health and the baby's development.

Quick facts

Study typeObservational
Enrollment60 (estimated)
Ages1 Day to 7 Days
SexAll
SponsorIRCCS Burlo Garofolo Academic / other
Locations1 site (Trieste)
Trial IDNCT05821569 on ClinicalTrials.gov

What this trial studies

This observational study investigates the synchronization of brain activity between mothers and their newborns during breastfeeding using functional near-infrared spectroscopy (fNIRS). It compares traditional breastfeeding positions with a new approach called biological nurturing, which aims to enhance the natural interaction between mother and baby. The study focuses on understanding how these interactions can influence both maternal mental health, particularly postpartum depression, and the overall development of the newborn. By analyzing cortical activation patterns, the research seeks to provide insights into the benefits of breastfeeding practices.

Who should consider this trial

Good fit: Ideal candidates for this study are full-term healthy newborns who are already breastfeeding and have no breast problems.

Not a fit: Patients who may not benefit from this study include those with syndromic diagnoses, major organ conditions, or mothers with a history of neurological disorders.

Why it matters

Potential benefit: If successful, this study could lead to improved breastfeeding practices that enhance maternal mental health and infant development.

How similar studies have performed: Preliminary data from similar studies using fNIRS have shown promising results in understanding mother-newborn interactions, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

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

Where this trial is running

Trieste

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Depression, PostpartumBreastfeedingNear-infrared spectroscopyPostpartum depression
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.