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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Maximum Age: 4 months
Healthy Volunteers: f
View:

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

Locations
Other Locations
Sweden
Umeå university hospital
RECRUITING
Umeå
Contact Information
Primary
Malin Bergman Papworth, PhD-student
malin.bergman.papworth@umu.se
0046 730438397
Time Frame
Start Date: 2024-11-20
Estimated Completion Date: 2029-10
Participants
Target number of participants: 176
Treatments
No_intervention: Controll group
Standard care
Other: INSPIRE-intervention
Intervention group, recieving the INSPIRE-intervention
Related Therapeutic Areas
Sponsors
Leads: Umeå University

This content was sourced from clinicaltrials.gov