NCT06688695 Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health
| NCT ID | NCT06688695 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Umeå University |
| Condition | Premature Infant |
| Study Type | INTERVENTIONAL |
| Enrollment | 176 participants |
| Start Date | 2024-11-20 |
| Primary Completion | 2029-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 176 participants in total. It began in 2024-11-20 with a primary completion date of 2029-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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-professional approach, the study team have developed a post-discharge "Intervention for Neurodevelopmental Support in Preterm Infants using Responsive parenting and E-health" (INSPIRE). Parents of very preterm infants will be included in the program at hospital discharge and will receive the intervention in 18 sessions over a two year period. The study team have assessed feasibility and refined the intervention in a pilot study including 9 families. This autumn, a randomized clinical trial will be performed to evaluate efficiency: Families will be randomized to the INSPIRE program or standard care. Follow-up and assessment of children (and parents) across a range of crucial domains will be performed up to at least 2 years of age. Societal relevance and utilisation The project will be the first in the world to use a digital e-health solution with video interaction to deliver a post discharge parental support intervention to parents of very preterm infants. The project has great potential to reduce the risk of cognitive impairment, behavioral problems, mental illness and eating disorders in these high risk children, as well as improving mental health and well-being in the parents. Parents of preterm infants are involved as co-creators in developing and evaluating the program. Plan for project realization Currently, there is no similar post-discharge program available. Based on the results, the study team aim to implement a sustainable, nationwide, post-discharge e-health intervention program to improve health in very preterm-born children and their parents, which will also reduce health inequality by ensuring the availability of high-quality support to families living far away from highly specialized health care facilities
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.
Contact & Investigator
Magnus Domellöf, Professor
STUDY DIRECTOR
Umeå universitet
Frequently Asked Questions
Who can join the NCT06688695 clinical trial?
This trial is open to participants of all sexes, aged 0 Months or older, up to 4 Months, studying Premature Infant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06688695 currently recruiting?
Yes, NCT06688695 is actively recruiting participants. Contact the research team at malin.bergman.papworth@umu.se for enrollment information.
Where is the NCT06688695 trial being conducted?
This trial is being conducted at Falun, Sweden, Östersund, Sweden, Södra Sunderbyn, Sweden, Karlstad, Sweden and 3 additional locations.
Who is sponsoring the NCT06688695 clinical trial?
NCT06688695 is sponsored by Umeå University. The principal investigator is Magnus Domellöf, Professor at Umeå universitet. The trial plans to enroll 176 participants.