Brain ActivityNCT05805254
Neurofunctional Study of Preterm Infants' Brain Activity
An observational study of Brain Activity and Preterm, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
During hospital stay, a family centered therapeutic approach is increasingly seen as the preferred clinical and care model to be adopted, since it is effective in promoting the neurobehavioral development of the infant and the psychophysical health of the family. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Brain Activity, Preterm
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 25 Mar 2018to 8 Aug 2022
- 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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants with gestational age at birth ≤32 weeks
Who may be able to join
- gestational age at birth ≤32 weeks
- absence of brain injury and neurological problems
- newborn-mother pairs in KMC
- adherence to research by parents.
Who cannot join
- contraindications to KMC and NIRS, according to internal protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurofunctional Study of the Brain Activity of Preterm Infants During Family-centered Interventions
During hospital stay, a family centered therapeutic approach is increasingly seen as the preferred clinical and care model to be adopted, since it is effective in promoting the neurobehavioral development of the infant and the psychophysical health of the family. In preterm infant, parental relationship and parental relationship-centered interventions, such as kangaroo mother care (KMC), are actively promoted. Studies carried out with electroencephalography showed that preterm infants who participated in KMC interventions have, when reach term equivalent age, a similar level of maturity as healthy full-term infants. It has also been observed that KMC carried out in preterm infant with gestational age <33 weeks promotes adequate development of the primary motor cortex during adolescence.
Recent scientific evidence showed an early response to relational stimulations, in particular to their emotional content, of term infants. After few days of life, the infant's brain picks up messages from the human context and interacts with them. For example, a study using near-infrared spectroscopy (NIRS) showed increased activation of the right frontal cortex in infants in association with their mother's direct speech. Similar neuroimaging studies have not yet been conducted in preterm infants during hospitalization. The aim of this study is to assess the activation of the cerebral cortex of the preterm infant in the course of 1) KMC and 2) listening to their mother's voice, using optical topography, a multichannel NIRS system.
- Conditions
- Brain Activity, Preterm
- Keywords
- Preterm infant, Kangaroo Mother care, family-centered interventions, near-infrared spectroscopy
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Values of cortical oxy-haemoglobin (HbO2) during KMC in preterm infants
Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring cortical oxy-haemoglobin (HbO2) values
Measured: During hospital stay, between 30 to 36 weeks of postmenstrual age
Secondary outcomes (1)
Values of cortical oxy-haemoglobin (HbO2) during the experience of listening the mother's voice and the voice of an unknown woman in preterm infants
Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring cortical oxy-haemoglobin (HbO2) values
Measured: During hospital stay, between 30 to 36 weeks of postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start25 Mar 2018
- Primary completion8 Aug 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ActivityStudies 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
- Prospective
- Enrolment
- 30 participants (actual)
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
- NCT05805254
- Sponsor's protocol ID
- RC 02/17
- Status last verified
- Apr 2023
- First submitted
- 24 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofunctional Study of the Brain Activity of Preterm Infants During Family-centered Interventions
- ClinicalTrials.gov ID
- NCT05805254
- Acronym / sponsor ID
- RC 02/17
- Conditions
- Brain Activity, Preterm
- Keywords
- Preterm infant, Kangaroo Mother care, family-centered interventions, near-infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 25 Mar 2018 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 7 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.
During hospital stay, a family centered therapeutic approach is increasingly seen as the preferred clinical and care model to be adopted, since it is effective in promoting the neurobehavioral development of the infant and the psychophysical health of the family. In preterm infant, parental relationship and parental relationship-centered interventions, such as kangaroo mother care (KMC), are actively promoted. Studies carried out with electroencephalography showed that preterm infants who participated in KMC interventions have, when reach term equivalent age, a similar level of maturity as healthy full-term infants. It has also been observed that KMC carried out in preterm infant with gestational age <33 weeks promotes adequate development of the primary motor cortex during adolescence.
Recent scientific evidence showed an early response to relational stimulations, in particular to their emotional content, of term infants. After few days of life, the infant's brain picks up messages from the human context and interacts with them. For example, a study using near-infrared spectroscopy (NIRS) showed increased activation of the right frontal cortex in infants in association with their mother's direct speech. Similar neuroimaging studies have not yet been conducted in preterm infants during hospitalization. The aim of this study is to assess the activation of the cerebral cortex of the preterm infant in the course of 1) KMC and 2) listening to their mother's voice, using optical topography, a multichannel NIRS system.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants with gestational age at birth ≤32 weeks
Key inclusion criteria (4 listed)
- gestational age at birth ≤32 weeks
- absence of brain injury and neurological problems
- newborn-mother pairs in KMC
- adherence to research by parents.
Key exclusion criteria (1 listed)
- contraindications to KMC and NIRS, according to internal protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Values of cortical oxy-haemoglobin (HbO2) during KMC in preterm infants
Time frame: During hospital stay, between 30 to 36 weeks of postmenstrual age
Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring cortical oxy-haemoglobin (HbO2) values
1 secondary outcome
Values of cortical oxy-haemoglobin (HbO2) during the experience of listening the mother's voice and the voice of an unknown woman in preterm infants
Time frame: During hospital stay, between 30 to 36 weeks of postmenstrual age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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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 Brain Activity and Preterm, 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 12 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Values of cortical oxy-haemoglobin (HbO2) during KMC in preterm infants (time frame: During hospital stay, between 30 to 36 weeks of postmenstrual age). 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 12 Apr 2023.