Building the Path to Resilience in Preterm Infants: Mindfulness-based Intervention

Pediatric Clinical Research Platform

Status: Active, not recruiting

Conditions: Behavioral Problem; Cognitive Dysfunction; Preterm Birth

Treatments: Behavioral: Mindfulness-based intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04638101

2015-00175

Details and patient eligibility

About

Yearly 15 million babies worldwide are born too soon. 10% of these preterm births occur very early before 32 weeks of gestation and these newborns are at high risk for neurodevelopmental disorders later in life. Neurocognitive disorders now touch 27% of the European population, and 5% or 3.3 million children suffer from social and learning difficulties, including attention-deficit hyperactivity disorders and autism, whose rates are increasing and prematurity contributes to this rise. Cognition, and socio-emotional competence are based on intact brain structure and functions that are formed early in development, both pre- and post-natally, and are heavily influenced by environment. Ramon y Cajal in his studies on the making of the brain clearly stated: "The total arborisation of a neuron represents the graphic history of conflicts suffered during its developmental life". Understanding how environment affects early brain development and defining timing and mode of early interventions to enhance brain development in high risk populations, such as preterm infants, is currently acknowledged as a fundamental endeavor for the scientific community (see guidelines of the National Scientific Council for the Developing Child). Interventions to improve and maintain cognitive and socio-emotional skills are to become an essential tool of medical care for high-risk infants. The goal of this study is to test the impact of a Mindfulness-based intervention - considered to target brain networks previously described as affected by prematurity and improve socio-emotional and executive functions. Mindfulness based intervention (intentional self-regulation of attention) will be performed in 10-13 year old preterm children, both from our prior studied preterm cohorts. Overall, our planned research will fill an important gap in our theoretical understanding of the brain vulnerability linked to prematurity. Even more importantly, the compelling issue of how to build cognitive and emotional resilience in preterm children will be addressed by preventing the onset of difficulties and reducing them with appropriate interventions.

Enrollment: 60 estimated patients

Sex: All

Ages: 10 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• born before 32 gestational weeks

Exclusion criteria

• severe sensory or physical disabilities (cerebral palsy, blindness, hearing loss)
• intelligence quotient below 70
• not French speaking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Intervention group (RCT)

Experimental group

Description:

Participants from the intervention group participated in the mindfulness-based intervention between Time 1 and Time 2.

Treatment:

Behavioral: Mindfulness-based intervention

Waiting group (RCT)

Experimental group

Description:

Participants from the waiting group took part in the mindfulness-based intervention between Time 2 and Time 3.

Treatment:

Behavioral: Mindfulness-based intervention