Depression, PostpartumNCT05821569
Cerebral Synchronization Between Mothers and Their Newborns During Breastfeeding
An observational study of Depression, Postpartum, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 7 days
- Conditions the study is for
- Depression, Postpartum
- What is being tested?
- Standard approach and Biological nurturing
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jan 2024to 15 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 7 days
- All sexes
- No healthy volunteers
- Child
Study population: Full term healthy newborns and their mothers.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Burlo Garofolo
Trieste, 34137
Stefano Bembich, MD, +390403785410, stefano.bembich@burlo.trieste.it
About this study
Official title: 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
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.
Read the detailed description
Breastfeeding is a very important experience since the beginning of life, supplying the best physical, biological and affective conditions for newborn's growth and development. Its promotion of motor, cognitive (e.g. language, memory), and emotional development in the long term was also observed. Benefits are for the mother too, including a reduction of the risk for postpartum depression. This clinical condition is the most common maternal psychiatric disorder after childbirth, observed in 10%-15% of mothers, and may adversely affect mother-newborn relationship, psychophysical maternal wellbeing, and infant development.
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.
Newborn cortical activation associated with breastfeeding was studied too. By functional near-infrared spectroscopy (fNIRS), a safe and minimally invasive functional neuroimaging technique based on haemoglobin absorption of near-infrared light, our research group 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
- Being tested
- Standard approach, Biological nurturing
- Keywords
- Breastfeeding, Near-infrared spectroscopy, Postpartum depression
- Medical subject headings
- Depression, Postpartum, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard approachOther
Adoption of standard approach (derived by Unicef guidelines) to breastfeed
Biological nurturingOther
Adoption of biological nurturing approach to breastfeed
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Biological nurturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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)
To evaluate differences in salivary oxytocin levels of mothers adopting the biological nurturing approach to breastfeed vs mothers adopting the standard position. In multivariate analysis also the intensity of maternal postpartum depressive symptoms assessed by EPDS will be take into account. EPDS is 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 maternal postpartum depression.
Measured: 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)
To evaluate differences in salivary oxytocin levels of newborns breastfed adopting the biological nurturing approach vs newborns breastfed adopting the standard position
Measured: At the second day after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start9 Jan 2024
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Bembich, MSC, Study director, IRCCS materno infantile Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821569
- Sponsor's protocol ID
- RC 53/22
- Status last verified
- Jan 2024
- First submitted
- 24 Mar 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05821569
- Acronym / sponsor ID
- RC 53/22
- Conditions
- Depression, Postpartum
- Keywords
- Breastfeeding, Near-infrared spectroscopy, Postpartum depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breastfeeding is a very important experience since the beginning of life, supplying the best physical, biological and affective conditions for newborn's growth and development. Its promotion of motor, cognitive (e.g. language, memory), and emotional development in the long term was also observed. Benefits are for the mother too, including a reduction of the risk for postpartum depression. This clinical condition is the most common maternal psychiatric disorder after childbirth, observed in 10%-15% of mothers, and may adversely affect mother-newborn relationship, psychophysical maternal wellbeing, and infant development.
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.
Newborn cortical activation associated with breastfeeding was studied too. By functional near-infrared spectroscopy (fNIRS), a safe and minimally invasive functional neuroimaging technique based on haemoglobin absorption of near-infrared light, our research group 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard position during breastfeeding | – | Other: Standard approachWomen 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 |
| biological nurturing | – | Other: Biological nurturingWomen who adopted, according to their preference and/or to the professional advice and support of the nursing staff, the biological nurturing approach to breastfeed |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Full term healthy newborns and their mothers.
Key inclusion criteria (6 listed)
- Full term healthy newborn
- Weight > 2500 gr
- Vaginal delivery
- Breastfeeding already started
- Absence of breast problems (e.g. cracked or sore nipple)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard approachAdoption of standard approach (derived by Unicef guidelines) to breastfeed | Other | standard position during breastfeeding |
| Biological nurturingAdoption of biological nurturing approach to breastfeed | Other | biological nurturing |
Primary outcome
To compare the frontal cerebral cortex functional synchronization in mother-newborn dyads adopting biological nurturing vs standard position to breastfeed
Time frame: At the second day after birth
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).
To compare the presence of postpartum depressive symptoms in women adopting biological nurturing vs standard position to breastfeed
Time frame: At the second day after birth
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.
2 secondary outcomes
To compare the oxytocin level of mothers adopting different position during breastfeeding (standard position vs biological nursing)
Time frame: 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)
Time frame: At the second day after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Bembich, MSC study director
IRCCS materno infantile Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Postpartum, run by IRCCS Burlo Garofolo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefano Bembich, MSC (+390403785111, stefano.bembich@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the frontal cerebral cortex functional synchronization in mother-newborn dyads adopting biological nurturing vs standard position to breastfeed (time frame: At the second day after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.