Actively Recruiting

Phase Not Applicable
Age: 0Months - 4Months
All Genders
NCT06688695

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

Led by Umeå University · Updated on 2026-01-28

176

Participants Needed

7

Research Sites

253 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 0Months - 4Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infant born before 32 weeks gestational age or with a birth weight under 1500 grams
Not Eligible

You will not qualify if you...

  • Parent(s) younger than 18 years old
  • Chromosomal abnormalities or congenital syndromes affecting development
  • Parents unable to understand Swedish
  • Parents with severe mental illness or physical medical conditions requiring extensive inpatient care
  • Families without a stable living situation such as substance abuse, homelessness, or risk of deportation from Sweden
  • Families who have previously participated in the INSPIRE study or pilot

AI-Screening

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Trial Site Locations

Total: 7 locations

1

Falu County Hospital

Falun, Dalarna County, Sweden, 791 82

Actively Recruiting

2

Östersund Hospital

Östersund, Jämtland Härjedalen, Sweden, 831 83

Actively Recruiting

3

Sunderby Hospital

Södra Sunderbyn, Norrbotten County, Sweden, 954 42

Actively Recruiting

4

Karlstad Hospital

Karlstad, Värmland County, Sweden, 651 85

Actively Recruiting

5

Umeå university hospital

Umeå, Västerbotten County, Sweden, 90185

Actively Recruiting

6

Sundsvall Hospital

Sundsvall, Västernorrland County, Sweden, 856 43

Actively Recruiting

7

Örebro University Hospital

Örebro, Örebro County, Sweden, 701 15

Actively Recruiting

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Research Team

M

Malin Bergman Papworth, PhD-student

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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