Clinical trial NCT06688695: Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health
Official title: Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health (INSPIRE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Infant
Premature Babies
Keywords: Early intervention
Responsive parenting
E-health
Prematurity
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 176
Sex: ALL
Minimum age (years): 0
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Research problem and specific questions More than 1000 very preterm infants (\&amp;amp;lt; 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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Bayley Scales of Infant Development (BSID IV)
timeFrame: 24 months corrected age
Secondary outcomes:
measure: Alberta infant motor scale (AIMS)
timeFrame: 6 months corrected age.
measure: Peabody Developmental Motor Scales (PDMS-2)
timeFrame: 24 months corrected age.
measure: Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI IV)
timeFrame: 5,5 years of age
measure: Movement ABC
timeFrame: 5,5 years of age
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: 24 months corrected age, 36 months of age and 5,5 years of age
measure: The Infant Toddler Checklist (ITC)
timeFrame: 18 months corrected age
measure: The MacArthur-Bates Communicative Development Inventories (MB-CDIs)
timeFrame: 12 and 18 months corrected age.
measure: "Jollerobservation"
timeFrame: 12 months corrected age.
measure: The Montreal Children's Hospital Feeding Scale
timeFrame: 12 months corrected age.
measure: The Emotional Availability Scale (EAS)
timeFrame: 12 months corrected age and 24 months corrected age.
measure: The Parental Reflective Functioning Questionnaire (PRFQ)
timeFrame: 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.
measure: Modified Checklist for Autism in Toddlers (M-CHAT
timeFrame: 24 months corrected age
measure: The Reynell Developmental Language Scales IV (RDLS IV)
timeFrame: 36 months of age.
measure: Ages and Stages Questionnaire (ASQ)
timeFrame: 24 months corrected age
measure: Swedish Parenthood Stress Questionnarie (SPSQ)
timeFrame: 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.
measure: Resilience Scale (RES)
timeFrame: 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.
measure: Parental Self-Efficacy Scale (PSE)
timeFrame: 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.
measure: The Hospital Anxiety and Depression scale (HAD)
timeFrame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age and 5,5 years of age.
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age and 5,5 years of age.
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå university hospital
state: Västerbotten
Study officials:
affiliation: Umeå universitet
name: Magnus Domellöf, Professor
role: STUDY_DIRECTOR
References: