Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health

Recruiting now · Not applicable

Conditions studied: Premature Infant, Premature Babies

In brief

Research problem and specific questions More than 1000 very preterm infants (\&amp;lt; 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

Key facts

Study ID: NCT06688695
Run by: Umeå University
People needed: 176
Starts: 2024-11-20
Expected to finish: 2029-10-01
Last updated by the study team: 2026-01-28

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Infant born before 32 GV, or with birth weight under 1500 gr.

You may not qualify if…

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 is running

Falu County Hospital — Falun, Dalarna County, Sweden (enrolling)
Östersund Hospital — Östersund, Jämtland Härjedalen, Sweden (enrolling)
Sunderby Hospital — Södra Sunderbyn, Norrbotten County, Sweden (enrolling)
Karlstad Hospital — Karlstad, Värmland County, Sweden (enrolling)
Umeå university hospital — Umeå, Västerbotten County, Sweden (enrolling)
Sundsvall Hospital — Sundsvall, Västernorrland County, Sweden (enrolling)
Örebro University Hospital — Örebro, Örebro County, Sweden (enrolling)

Full record on ClinicalTrials.gov

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