Actively Recruiting
Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health (INSPIRE)
Led by Umeå University · Updated on 2026-01-28
176
Participants Needed
7
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating a new e-health program designed to improve the neurodevelopment of very preterm infants, born before 32 weeks or with low birth weight, by supporting parents in responsive caregiving. The study aims to see if this program, called INSPIRE, can enhance cognitive, motor, feeding, language, and socio-emotional development up to 2 years of age. Additional goals include assessing parental stress, emotional availability, health inequalities, and gender differences. This trial is conducted by Umeå University with a multi-professional team and builds on a pilot study involving nine families. The intervention group will receive the INSPIRE program, which consists of 18 sessions delivered digitally over two years, starting at hospital discharge. This program focuses on strengthening parent-child interactions and empowering parents with responsive parenting skills. Families in the control group will receive standard care without the INSPIRE intervention. The study randomly assigns families to either group and follows up with assessments over time. Participants will be involved from discharge through at least 2 years corrected age, with evaluations including neurodevelopmental tests such as the Bayley Scales of Infant Development at 24 months. Additional assessments cover motor skills, language, feeding, emotional availability, parental stress, and mental health using various standardized tools at multiple time points up to 5.5 years of age. Researchers will monitor child development, parent well-being, and other outcomes to understand the intervention's impact and safety over the study period.
CONDITIONS
Brief 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
- Parents able to understand Swedish
- Parents aged 18 years or older
- Infant younger than 4 months old
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 conditions requiring extensive inpatient care
- Families without a stable living situation, such as substance abuse, homelessness, or threat of deportation
- Families that have previously participated in the INSPIRE study or pilot study
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months corrected age
Participants receive the INSPIRE behavioral intervention aimed at supporting infant neurodevelopment through responsive parenting and e-health methods.
Regular visits scheduled during the intervention period
Duration - Up to 5.5 years of age
Participants are monitored at multiple time points up to 5.5 years to assess neurodevelopmental outcomes and parental wellbeing.
Multiple follow-up visits at 6 months, 12 months, 18 months, 24 months, 36 months, and 5.5 years
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
Actively Recruiting
3
Sunderby Hospital
Södra Sunderbyn, Norrbotten County, Sweden, 954 42
Actively Recruiting
4
Karlstad Hospital
Karlstad, Värmland County, Sweden, 651 85
Actively Recruiting
5
Umeå university hospital
Umeå, Västerbotten County, Sweden, 90185
Actively Recruiting
6
Sundsvall Hospital
Sundsvall, Västernorrland County, Sweden, 856 43
Actively Recruiting
7
Örebro University Hospital
Örebro, Örebro County, Sweden, 701 15
Actively Recruiting
Research Team
M
Malin Bergman Papworth, PhD-student
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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