An interventional study of Tele-care video-feedback intervention (TVFI) in Premature Birth, sponsored by IRCCS National Neurological Institute "C. Mondino" Foundation. Recruiting at 2 sites in Italy. Open to participants aged Up to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-26.
Sponsored by IRCCS National Neurological Institute "C. Mondino" Foundation · Not applicable, Interventional, and Supportive care
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.
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 159 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →IRCCS National Neurological Institute "C. Mondino" Foundation is the lead sponsor of 57 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Mother-infant dyads will partecipate in 6 weekly 1-hour sessions of Tele-care video-feedback intervention
Behavioral: Tele-care video-feedback intervention (TVFI)
Usual care; no VF intervention. This arm will act as a control group matched to preterm conditions of VPT-VF.
Usual care; no VF intervention. This arm will act as an additional control group unmatched to preterm conditions.
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.
Phase-Locking Value (PLV)
EEG index of brain-to-brain co-regulation among PT and FT parent-infant dyads
Time frame: 9 months (infant's corrected age)
Amplitude-Amplitude Coupling (AAC)
EEG index of brain-to-brain co-regulation among PT and FT parent-infant dyads
Time frame: 9 months (infant's corrected age)
Imaginary Coherence (ICoh)
EEG index of brain-to-brain co-regulation among PT and FT parent-infant dyads
Time frame: 9 months (infant's corrected age)
Parental NICU-related stress
Parental Stressor Scale - NICU (PSS-NICU) (Miles, 1993).
Time frame: NICU discharge T1 (only VPT)
Sensory profile
Sensory Profile-2 (SP-2) (Dunn, 2014)
Time frame: 3 months (infant's corrected age) T2
Sensory profile
Sensory Profile-2 (SP-2) (Dunn, 2014)
Time frame: 6 months (infant's corrected age) T3
Sensory profile
Sensory Profile-2 (SP-2) (Dunn, 2014)
Time frame: 9 months (infant's corrected age) T4
Anxiety symptoms
State-Trait Anxiety Inventory (STAI-Y) (Spielberger et al., 1983)
Time frame: 3 months (infant's corrected age) T2
Anxiety symptoms
State-Trait Anxiety Inventory (STAI-Y) (Spielberger et al., 1983)
Time frame: 9 months (infant's corrected age) T4
Depression symptoms
Beck Depression Inventory (BDI-II) (Beck et al., 1996)
Time frame: 3 months (infant's corrected age) T2
Depression symptoms
Beck Depression Inventory (BDI-II) (Beck et al., 1996)
Time frame: 9 months (infant's corrected age) T4
Parenting stress
Parenting Stress Index - Short Form (PSI-SF) (Abidin, 1995)
Time frame: 3 months (infant's corrected age) T2
Parenting stress
Parenting Stress Index - Short Form (PSI-SF) (Abidin, 1995)
Time frame: 6 months (infant's corrected age) T3
Parenting stress
Parenting Stress Index - Short Form (PSI-SF) (Abidin, 1995)
Time frame: 9 months (infant's corrected age) T4
Temperament
Infant Behavior Questionnaire-Revised (IBQ-R) very short form (Gartstein \& Rothbart, 2003)
Time frame: 3 months (infant's corrected age) T2
Temperament
Infant Behavior Questionnaire-Revised (IBQ-R) very short form (Gartstein \& Rothbart, 2003)
Time frame: 6 months (infant's corrected age) T3
Temperament
Infant Behavior Questionnaire-Revised (IBQ-R) very short form (Gartstein \& Rothbart, 2003)
Time frame: 9 months (infant's corrected age) T4
Language and communication development
Italian adaptation of the MacArthur-Bates Communicative Development Inventory (MB-CDI Fenson et al., 2007)
Time frame: 3 months (infant's corrected age) T2
Language and communication development
Italian adaptation of the MacArthur-Bates Communicative Development Inventory (MB-CDI Fenson et al., 2007)
Time frame: 6 months (infant's corrected age) T3
Language and communication development
Italian adaptation of the MacArthur-Bates Communicative Development Inventory (MB-CDI Fenson et al., 2007)
Time frame: 9 months (infant's corrected age) T4
Plan to share: Yes — Raw data will be made available upon request through Zenodo repository
Supporting information: Sap
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IRCCS National Neurological Institute "C. Mondino" Foundation