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

NCT ID: NCT04638101

Last Updated: 2020-11-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2025-08-01

Brief Summary

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.

Conditions

Preterm Birth; Cognitive Dysfunction; Behavioral Problem

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group (RCT)

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

Group Type: EXPERIMENTAL

Mindfulness-based intervention

Intervention Type: BEHAVIORAL

Mindfulness-based intervention: The proposed MBI was designed based on well-known MBI programs including Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy and adapted to adolescents' needs and language. The program consisted of 8 weekly sessions in groups of up to 8 participants, lasting 1h30. Two MBI groups were offered per week (Wednesdays and Fridays) and participants had the possibility to choose the most convenient day for them. Two instructors were present for each group throughout the intervention.For each session one theme was addressed, such as attention and the stabilisation of the focus of attention, bodily sensations, breath, emotions, thoughts, compassion, stress, stress reactivity and coping strategies.

Waiting group (RCT)

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

Group Type: EXPERIMENTAL

Mindfulness-based intervention

Intervention Type: BEHAVIORAL

Mindfulness-based intervention: The proposed MBI was designed based on well-known MBI programs including Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy and adapted to adolescents' needs and language. The program consisted of 8 weekly sessions in groups of up to 8 participants, lasting 1h30. Two MBI groups were offered per week (Wednesdays and Fridays) and participants had the possibility to choose the most convenient day for them. Two instructors were present for each group throughout the intervention.For each session one theme was addressed, such as attention and the stabilisation of the focus of attention, bodily sensations, breath, emotions, thoughts, compassion, stress, stress reactivity and coping strategies.

Interventions

Mindfulness-based intervention

Mindfulness-based intervention: The proposed MBI was designed based on well-known MBI programs including Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy and adapted to adolescents' needs and language. The program consisted of 8 weekly sessions in groups of up to 8 participants, lasting 1h30. Two MBI groups were offered per week (Wednesdays and Fridays) and participants had the possibility to choose the most convenient day for them. Two instructors were present for each group throughout the intervention.For each session one theme was addressed, such as attention and the stabilisation of the focus of attention, bodily sensations, breath, emotions, thoughts, compassion, stress, stress reactivity and coping strategies.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pediatric Clinical Research Platform

OTHER

Sponsor Role: lead

Responsible Party

Petra Hüppi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Siffredi V, Liverani MC, Huppi PS, Freitas LGA, De Albuquerque J, Gimbert F, Merglen A, Meskaldji DE, Borradori Tolsa C, Ha-Vinh Leuchter R. The effect of a mindfulness-based intervention on executive, behavioural and socio-emotional competencies in very preterm young adolescents. Sci Rep. 2021 Oct 6;11(1):19876. doi: 10.1038/s41598-021-98608-2.

Reference Type: DERIVED

PMID: 34615893 (View on PubMed)

Siffredi V, Liverani MC, Smith MM, Meskaldji DE, Stuckelberger-Grobety F, Freitas LGA, De Albuquerque J, Savigny E, Gimbert F, Huppi PS, Merglen A, Borradori Tolsa C, Leuchter RH. Improving executive, behavioural and socio-emotional competences in very preterm young adolescents through a mindfulness-based intervention: Study protocol and feasibility. Early Hum Dev. 2021 Oct;161:105435. doi: 10.1016/j.earlhumdev.2021.105435. Epub 2021 Jul 31.

Reference Type: DERIVED

PMID: 34507019 (View on PubMed)

Other Identifiers

2015-00175

Identifier Type: -

Identifier Source: org_study_id