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Premature Birth2-BRAINEDNCT06659809

2-Brain Regulation to Achieve Improved Neuroprotection During Early Development

A study testing Tele-care video-feedback intervention (TVFI) in people with Premature Birth, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 2 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Each year 15 million infants are born preterm (PT). Even without severe comorbidities, they are exposed to sensory stress during the Neonatal Intensive Care Unit (NICU) stay and are at greater risk of neurodevelopmental problems compared to full-term (FT) counterparts in the short- and long-term period. Read more about this study

Who is it for?
Ages Up to 3 monthsHealthy volunteers can take part
Conditions the study is for
Premature Birth
What is being tested?
Tele-care video-feedback intervention (TVFI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
159 participants
Where
2 sitesItaly
Study dates
24 Apr 2023to 24 Apr 2026
Phase
Interventional
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 3 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • infants' (corrected) age between birth and 3 months;
  • parental age greater than 18 years;
  • parental mastery of Italian language;
  • parents living together with the infant;

Who cannot join

  • infant's major comorbidities (e.g., genetic syndromes, malformations, brain injuries);
  • parental psychiatric diagnoses;

Trial locations and contacts

2 sites in 1 country.

Livio Provenzi, PhD contact

0382380287

livio.provenzi@mondino.it

Serena Grumi, PhD contact

0382380287

serena.grumi@mondino.it

Italy2 sites, 1 recruiting
  • Scientific Institute IRCCS E. Medea

    Bosisio Parini

    Valentina Riva, PhD, valentina.riva@lanostrafamiglia.it

    Recruiting
  • CNR Pisa

    Pisa

    Active, not recruiting

Other trials in Italy

About this study

Official title: 2-Brain Regulation to Achieve Improved Neuroprotection During Early Development (2- BRAINED)

Each year 15 million infants are born preterm (PT). Even without severe comorbidities, they are exposed to sensory stress during the Neonatal Intensive Care Unit (NICU) stay and are at greater risk of neurodevelopmental problems compared to full-term (FT) counterparts in the short- and long-term period. Altered biobehavioral interpersonal synchrony patterns are documented in PT parent-infant dyads and might contribute to detrimental outcomes. Electroencephalographic (EEG) hyperscanning provides innovative real-time central biomarkers of brain-to-brain co-regulation; it was never applied to PT mother-infant dyads. Early parenting video-feedback (VF) interventions promote at-risk infants' neurodevelopment, yet action mechanisms are partially unknown. The present longitudinal project aims (a) to compare indexes of brain-to-brain co-regulation between dyads of full-term (FT) and VPT infants interacting with their mothers and (b) to investigate the effect of an early post-discharge VF intervention on the brain-to-brain co-regulation indexes of VPT dyads. This study will establish translational hyperscanning as a new field of innovative research with crucial clinical implications.

Read the detailed description

Very preterm (VPT) birth is a major risk condition for child neurological and behavioral development and as well as for parental well-being, mainly due to multiple sources of stress (e.g., separation and pain exposure) during the hospitalization. Even in absence of severe critical medical comorbidities, VPT infants and their parents are exposed to multiple stress sources during the stay in the hospitalization in the Neonatal Intensive Care Unit (NICU), including early parent-infant separation and pain. Early parenting video-feedback (VF) interventions focused on promoting parent-infant closeness through the video-feedback (VF) approach methodology have proven effective in promoting child development and parental well-being. Electroencephalography (EEG) hyperscanning paradigms allow the assessment of brain-to-brain co-regulation during live interaction between infants and parents and hold promises to highlight mechanisms behind the interactive benefits of early VF parenting interventions. The 2-Brain Regulation to Achieve Improved Neuroprotection during Early Development (2-BRAINED) research project aims (a) to compare indexes of brain-to-brain co-regulation between dyads of full-term (FT) and VPT infants interacting with their mothers and (b) to investigate the effect of an early post-discharge VF intervention on the brain-to-brain co-regulation indexes of VPT dyads.

The 2-BRAINED project is a randomized-controlled trial (RCT) with three arms (see arm description). VPT (gestational age below 35 weeks) and FT (gestational age above 37 weeks) dyads will be enrolled at birth and the former will be randomly allocated to one of two arms: VF intervention or care as usual. The VF intervention will be delivered during the first three months after NICU discharge, consisting of and consists of 8 weekly remote VF sessions focused on sensory, behavioral, cognitive, and affective dimensions of parenting. Before and after the intervention, videotaped mother-infant interaction will provide pre-post behavioral data to assess the short-term effectiveness of the VF intervention. Videos will be micro-analytically coded for infant's and caregivers' target behaviors.

Mothers of VPT and FT infants will fill in questionnaires focused on maternal well-being (symptoms of depression [Beck Depression Inventory, BDI; Beck et al.,1961] and anxiety [State-Trait Anxiety Inventory, STAI-Y, Spielberg, 1983]), parenting (parental stress and mother-infant bonding [Parenting Stress Index, PSI; Abidin, 1983]), and infant development (language [Italian adaptation of the MacArthur-Bates Communicative Development Inventory; Caselli \& Casadio, 1995]; temperament [Infant Behavior Questionnaire Revised, IBQ-R, Gartstein et al., 2003] and sensory profile [Sensory Profile 2, SP-2, Dunn, 2014]) at 3, 6 and 9 months (corrected age, CA).

At 9 months CA, all dyads will take part in a lab-based 5-min EEG- hyperscanning Still-Face task (Tronick et al., 1978; Provenzi et al., 2016) in the laboratory to assess brain-to-brain co-regulation, during which EEG activity from both the interactive partners will be recorded using two 32-electrode caps linked with two PC-connected wireless amplifiers (Smarting mBrainTrain) that will assure complete freedom of movements. Several indexes used to measure of brain-to-brain co-regulation will be tested and compared, including Phase-Locking Value (PLV), Amplitude-Amplitude Coupling (AAC) and imaginary coherence (ICoh). These indexes will be used to compare brain-to-brain co-regulation indexes (a) between PT and FT infants to test difference in interpersonal neurophysiological attunement in typical and at-risk infants as well as (b) between PTCU and PTVF. Moreover, best-fitting synchrony indexes will be used in a path analysis model testing the mediating role of brain-to-brain co-regulation indexes on the effects of VF early parental intervention on the short- and long-term outcomes. A prediction model will be implemented to predict outcomes on the basis of both clinical and EEG measures.

Conditions
Premature Birth
Being tested
Tele-care video-feedback intervention (TVFI)
Keywords
preterm birth, EEG, hyperscanning, video-feedback, early intervention, brain-to-brain co-regulation
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tele-care video-feedback intervention (TVFI)Behavioural

    The TVFI 6 weekly sessions are organized in two subsequent phases: 4 sharing the focus sessions and 2 integration sessions. Sharing the focus sessions are dedicated to the discussion between the psychologist and the mother of specific themes related to parenting and parent-infant interaction: physical stimulation, responsiveness, teaching, and parenting experience. The goal of the sharing the focus sessions is to develop insights about the infants' behavioral signals, the best ways to provide stimulations and get in touch, strategies to promote emotion regulation, and to sustain cognitive and behavioral achievements. In the subsequent two integration sessions, the mother plays with the infant while the psychologist provides guidance based on topics previously discussed during the first four sessions. The goal is to promote a pragmatical translation of the insights developed during the sharing the focus sessions into the interactive exchanges between the mother and the infant.

Study groups in NCT06659809
Study groupRoleWhat they receive
VPT infants and their caregivers randomly allocated to the intervention arm (VPT-VF)ExperimentalMother-infant dyads will partecipate in 6 weekly 1-hour sessions of Tele-care video-feedback intervention
Receives: Behavioral: Tele-care video-feedback intervention (TVFI)
VPT infants and their caregivers randomly allocated to the care as usual arm (VPT-CU)No interventionUsual care; no VF intervention. This arm will act as a control group matched to preterm conditions of VPT-VF.
FT infants and their caregivers (FT-CG)No interventionUsual care; no VF intervention. This arm will act as an additional control group unmatched to preterm conditions.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase-Locking Value (PLV)

    EEG index of brain-to-brain co-regulation among PT and FT parent-infant dyads

    Measured: 9 months (infant's corrected age)

  2. Amplitude-Amplitude Coupling (AAC)

    EEG index of brain-to-brain co-regulation among PT and FT parent-infant dyads

    Measured: 9 months (infant's corrected age)

  3. Imaginary Coherence (ICoh)

    EEG index of brain-to-brain co-regulation among PT and FT parent-infant dyads

    Measured: 9 months (infant's corrected age)

Secondary outcomes (17)
  1. Parental NICU-related stress

    Parental Stressor Scale - NICU (PSS-NICU) (Miles, 1993).

    Measured: NICU discharge T1 (only VPT)

  2. Sensory profile

    Sensory Profile-2 (SP-2) (Dunn, 2014)

    Measured: 3 months (infant's corrected age) T2

  3. Sensory profile

    Sensory Profile-2 (SP-2) (Dunn, 2014)

    Measured: 6 months (infant's corrected age) T3

  4. Sensory profile

    Sensory Profile-2 (SP-2) (Dunn, 2014)

    Measured: 9 months (infant's corrected age) T4

  5. Anxiety symptoms

    State-Trait Anxiety Inventory (STAI-Y) (Spielberger et al., 1983)

    Measured: 3 months (infant's corrected age) T2

  6. Anxiety symptoms

    State-Trait Anxiety Inventory (STAI-Y) (Spielberger et al., 1983)

    Measured: 9 months (infant's corrected age) T4

  7. Depression symptoms

    Beck Depression Inventory (BDI-II) (Beck et al., 1996)

    Measured: 3 months (infant's corrected age) T2

  8. Depression symptoms

    Beck Depression Inventory (BDI-II) (Beck et al., 1996)

    Measured: 9 months (infant's corrected age) T4

  9. Parenting stress

    Parenting Stress Index - Short Form (PSI-SF) (Abidin, 1995)

    Measured: 3 months (infant's corrected age) T2

  10. Parenting stress

    Parenting Stress Index - Short Form (PSI-SF) (Abidin, 1995)

    Measured: 6 months (infant's corrected age) T3

  11. Parenting stress

    Parenting Stress Index - Short Form (PSI-SF) (Abidin, 1995)

    Measured: 9 months (infant's corrected age) T4

  12. Temperament

    Infant Behavior Questionnaire-Revised (IBQ-R) very short form (Gartstein \& Rothbart, 2003)

    Measured: 3 months (infant's corrected age) T2

  13. Temperament

    Infant Behavior Questionnaire-Revised (IBQ-R) very short form (Gartstein \& Rothbart, 2003)

    Measured: 6 months (infant's corrected age) T3

  14. Temperament

    Infant Behavior Questionnaire-Revised (IBQ-R) very short form (Gartstein \& Rothbart, 2003)

    Measured: 9 months (infant's corrected age) T4

  15. Language and communication development

    Italian adaptation of the MacArthur-Bates Communicative Development Inventory (MB-CDI Fenson et al., 2007)

    Measured: 3 months (infant's corrected age) T2

  16. Language and communication development

    Italian adaptation of the MacArthur-Bates Communicative Development Inventory (MB-CDI Fenson et al., 2007)

    Measured: 6 months (infant's corrected age) T3

  17. Language and communication development

    Italian adaptation of the MacArthur-Bates Communicative Development Inventory (MB-CDI Fenson et al., 2007)

    Measured: 9 months (infant's corrected age) T4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2024
  2. Study start24 Apr 2023
  3. Primary completion24 Dec 2025 (estimated)
  4. Study completion24 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
159 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06659809
Sponsor's protocol ID
2-BRAINED
Acronym
2-BRAINED
Status last verified
May 2024
First submitted
29 May 2024
Last updated
26 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Raw data will be made available upon request through Zenodo repository

Questions about this trial

What is this clinical trial studying?

A study testing Tele-care video-feedback intervention (TVFI) in people with Premature Birth, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 2 sites 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 2 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 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Livio Provenzi, PhD (0382380287, livio.provenzi@mondino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase-Locking Value (PLV) (time frame: 9 months (infant's corrected age)). The study lists 3 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 26 Oct 2024.

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