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Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health
Led by Umeå University · Updated on 2026-01-28
176
Participants Needed
7
Research Sites
253 weeks
Total Duration
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AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infant born before 32 weeks gestational age or with a birth weight under 1500 grams
You will not qualify if you...
- Parent(s) younger than 18 years old
- Chromosomal abnormalities or congenital syndromes affecting development
- Parents unable to understand Swedish
- Parents with severe mental illness or physical medical conditions requiring extensive inpatient care
- Families without a stable living situation such as substance abuse, homelessness, or risk of deportation from Sweden
- Families who have previously participated in the INSPIRE study or pilot
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Falu County Hospital
Falun, Dalarna County, Sweden, 791 82
Actively Recruiting
2
Östersund Hospital
Östersund, Jämtland Härjedalen, Sweden, 831 83
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3
Sunderby Hospital
Södra Sunderbyn, Norrbotten County, Sweden, 954 42
Actively Recruiting
4
Karlstad Hospital
Karlstad, Värmland County, Sweden, 651 85
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5
Umeå university hospital
Umeå, Västerbotten County, Sweden, 90185
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6
Sundsvall Hospital
Sundsvall, Västernorrland County, Sweden, 856 43
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7
Örebro University Hospital
Örebro, Örebro County, Sweden, 701 15
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Research Team
M
Malin Bergman Papworth, PhD-student
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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