Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health

Официальное название

Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health (INSPIRE)

Обзор

Research problem and specific questions More than 1000 very preterm infants (\< 32 weeks) are born every year in Sweden. They are at high risk of neurodevelopmental disabilities and mental illness throughout the lifespan. The overall purpose is to develop and evaluate a novel e-health intervention aimed at improving neurodevelopment (cognitive, motor, feeding, language, socio-emotional) of very preterm infants by supporting responsive parenting behaviours. The primary research question is whether the intervention improves child neurodevelopment up to 2 years. Further research questions relate to the emotional availability of parents and children, parental stress and overall experience as well as effects on health inequalities and gender effects. Data and method Using a multi-professional approach, the study team have developed a post-discharge "Intervention for Neurodevelopmental Support in Preterm Infants using Responsive parenting and E-health" (INSPIRE). Parents of very preterm infants will be included in the program at hospital discharge and will receive the intervention in 18 sessions over a two year period. The study team have assessed feasibility and refined the intervention in a pilot study including 9 families. This autumn, a randomized clinical trial will be performed to evaluate efficiency: Families will be randomized to the INSPIRE program or standard care. Follow-up and assessment of children (and parents) across a range of crucial domains will be performed up to at least 2 years of age. Societal relevance and utilisation The project will be the first in the world to use a digital e-health solution with video interaction to deliver a post discharge parental support intervention to parents of very preterm infants. The project has great potential to reduce the risk of cognitive impairment, behavioral problems, mental illness and eating disorders in these high risk children, as well as improving mental health and well-being in the parents. Parents of preterm infants are involved as co-creators in developing and evaluating the program. Plan for project realization Currently, there is no similar post-discharge program available. Based on the results, the study team aim to implement a sustainable, nationwide, post-discharge e-health intervention program to improve health in very preterm-born children and their parents, which will also reduce health inequality by ensuring the availability of high-quality support to families living far away from highly specialized health care facilities

Вмешательства

• Поведенческое Neurodevelopmental support
  The Intervention for Neurodevelopmental Support in Preterm Infants using Responsive parenting and E-health (INSPIRE) aims to support the infant's neurodevelopment by supporting the parents to develop a responsive approach. The intervention will enhance the infant's social and environmental interactions, focusing on developing both the infant's and parent's strengths, seeking opportunities instead of problems in behaviour, enhancing mutually satisfying interaction and parental empowerment.

Первичные конечные точки

• Bayley Scales of Infant Development (BSID IV) [Срок оценки: 24 months corrected age]

Вторичные конечные точки (12)

• Alberta infant motor scale (AIMS) [Срок оценки: 6 months corrected age.]
• Peabody Developmental Motor Scales (PDMS-2) [Срок оценки: 24 months corrected age.]
• Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI IV) [Срок оценки: 5,5 years of age]
• Movement ABC [Срок оценки: 5,5 years of age]
• Strengths and Difficulties Questionnaire (SDQ) [Срок оценки: 24 months corrected age, 36 months of age and 5,5 years of age]
• The Infant Toddler Checklist (ITC) [Срок оценки: 18 months corrected age]
• The MacArthur-Bates Communicative Development Inventories (MB-CDIs) [Срок оценки: 12 and 18 months corrected age.]
• "Jollerobservation" [Срок оценки: 12 months corrected age.]
• The Montreal Children's Hospital Feeding Scale [Срок оценки: 12 months corrected age.]
• The Emotional Availability Scale (EAS) [Срок оценки: 12 months corrected age and 24 months corrected age.]
• The Parental Reflective Functioning Questionnaire (PRFQ) [Срок оценки: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age, 24 months corrected age, and 36 months of age and 5,5 years of age.]
• Modified Checklist for Autism in Toddlers (M-CHAT [Срок оценки: 24 months corrected age]

Критерии участия

Критерии включения

\* Infant born before 32 GV, or with birth weight under 1500 gr.

Критерии исключения

• Parent(s) younger than 18 ya.
• Chromosomal abnormalities, congenital syndromes that may affect the child's development.
• Parents unable to understand Swedish.
• Parents with severe mental illness or a physical medical condition requiring extensive inpatient care.
• Families without a stable living situation, such as parental substance abuse, homelessness, or family living under threat of deportation from Sweden.
• Families that have previously participated in the INSPIRE study or the INSPIRE pilot study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Швеция · 7 центров

• Falu County Hospital — Falun
• Östersund Hospital — Östersund
• Sunderby Hospital — Södra Sunderbyn
• Karlstad Hospital — Karlstad
• Umeå university hospital — Umeå
• Sundsvall Hospital — Sundsvall
• Örebro University Hospital — Örebro

Идентификаторы

NCT: NCT06688695 · EPM Dnr 2024-03048-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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