Clinical trial Recruiting at 7 sites Interventional Ages 0 Months to 4 Months

Support for neurodevelopment in preterm infants through responsive parenting and e-health

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

Run by Umeå University · NCT06688695 · Data updated 2026-11-12

This study tests a new online program to see if it can help parents of very preterm infants support their babies' brain development and overall growth by encouraging responsive parenting.

Quick facts

Study typeInterventional
Ages0 Months to 4 Months
SexAll
Enrollment176 (estimated)
SponsorUmeå University
Academic / other
Locations7 sites (Falun, Dalarna County and 6 other locations)
StatusRecruiting
StartedNovember 20, 2024
Main results expectedOctober 2029
Study endsOctober 2029
Registry record updatedJanuary 28, 2026
Trial IDNCT06688695 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are infants born before 32 weeks of gestation or with a birth weight under 1500 grams.

Probably not a fit

Patients who may not benefit from this study include those with chromosomal abnormalities, congenital syndromes affecting development, or families facing severe social challenges.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop and evaluate an innovative e-health intervention designed to enhance the neurodevelopment of very preterm infants by promoting responsive parenting behaviors. The intervention targets cognitive, motor, feeding, language, and socio-emotional development in infants born before 32 weeks of gestation. The primary focus is to assess whether this intervention leads to improved neurodevelopmental outcomes by the age of two. Additionally, the study will explore the emotional availability of parents and children, parental stress, and the overall experience of families, while also considering health inequalities and gender effects.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the neurodevelopmental outcomes of very preterm infants, potentially reducing the risk of long-term disabilities.

How similar studies have gone: Other studies have shown promise in using responsive parenting and e-health interventions for developmental support, suggesting a potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Falu County Hospital
    Falun, Dalarna County, Sweden
    Recruiting
  • Östersund Hospital
    Östersund, Jämtland Härjedalen, Sweden
    Recruiting
  • Sunderby Hospital
    Södra Sunderbyn, Norrbotten County, Sweden
    Recruiting
  • Karlstad Hospital
    Karlstad, Värmland County, Sweden
    Recruiting
  • Umeå university hospital
    Umeå, Västerbotten County, Sweden
    Recruiting
  • Sundsvall Hospital
    Sundsvall, Västernorrland County, Sweden
    Recruiting
Show 1 more location
  • Örebro University Hospital
    Örebro, Örebro County, Sweden
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.