Support for neurodevelopment in preterm infants through responsive parenting and e-health
Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health (INSPIRE)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 0 Months to 4 Months |
| Sex | All |
| Sponsor | Umeå University Academic / other |
| Locations | 7 sites (Falun, Dalarna County and 6 other locations) |
| Trial ID | NCT06688695 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born before 32 weeks of gestation or with a birth weight under 1500 grams.
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.
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 performed: Other studies have shown promise in using responsive parenting and e-health interventions for developmental support, suggesting a potential for success in this approach.
Eligibility criteria
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 this trial is running
Falun, Dalarna County and 6 other locations
- 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)
- Örebro University Hospital — Örebro, Örebro County, Sweden (Recruiting)
Study contacts
- Study coordinator: Malin Bergman Papworth, PhD-student
- Email: malin.bergman.papworth@umu.se
- Phone: 0046 730438397
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.