Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health
Launched by UMEÅ UNIVERSITY · Nov 12, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called INSPIRE, is designed to help very preterm infants—those born before 32 weeks of pregnancy or weighing less than 1500 grams—develop better during their early years. The study aims to see if a new digital program, which includes video interactions and guidance for parents, can improve important skills like thinking, movement, communication, and emotional health in these infants. The program will support parents in using responsive parenting techniques to nurture their child's development. Researchers will compare families participating in the INSPIRE program with those receiving standard care to see which approach works better over the first two years of the child's life.
To be eligible for the study, parents must be at least 18 years old and have a very preterm infant. Families dealing with severe mental health issues, unstable living situations, or certain medical conditions that could affect the child’s development may not be eligible. Participants can expect to join 18 sessions of support over two years, where they will receive practical advice and resources to help them care for their child. This trial is important because it seeks to reduce risks of developmental problems in high-risk babies while also supporting their parents' mental health and well-being.
Gender
ALL
Eligibility 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.
About Umeå University
Umeå University, a leading research institution in Sweden, is dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on interdisciplinary collaboration, the university harnesses cutting-edge technology and expert knowledge across various fields to address critical health challenges. Its commitment to ethical standards and patient safety ensures that all clinical trials conducted under its auspices are designed to generate robust scientific evidence, ultimately contributing to improved health outcomes and informed medical practices. Umeå University strives to foster a dynamic research environment that supports the development of new therapies and enhances the understanding of complex health issues.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Umeå, , Sweden
Umeå, Västerbotten, Sweden
Patients applied
Trial Officials
Magnus Domellöf, Professor
Study Director
Umeå universitet
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported