Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting
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 i
| Condition(s) | Premature Infant, Premature Babies |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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-pro |
| Who can participate | 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. |
| Ages | 0 Months to 4 Months |
| Sex | All |
| Lead sponsor | Umeå University |
| Locations | Falun, Dalarna County, Sweden; Östersund, Jämtland Härjedalen, Sweden; Södra Sunderbyn, Norrbotten County, Sweden; Karlstad, Värmland County, Sweden; Umeå, Västerbotten County, Sweden; Sundsvall, Västernorrland County, Sweden (+1 more sites) |
| Start date | 2024-11-20 |
| NCT ID | NCT06688695 |
| Official listing | https://clinicaltrials.gov/study/NCT06688695 |