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

NCT06688695 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2026-01-28

No results posted yet for this study

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

Conditions

  • Premature Infant
  • Premature Babies

Interventions

BEHAVIORAL

Neurodevelopmental support

The Intervention for Neurodevelopmental Support in Preterm Infants using Responsive parenting and E-health (INSPIRE) aims to support the infant's neurodevelopment by supporting the parents to develop a responsive approach. The intervention will enhance the infant's social and environmental interactions, focusing on developing both the infant's and parent's strengths, seeking opportunities instead of problems in behaviour, enhancing mutually satisfying interaction and parental empowerment.

Sponsors & Collaborators

  • Umeå University

    lead OTHER

Principal Investigators

  • Magnus Domellöf, Professor · Umeå universitet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
0 Months
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-20
Primary Completion
2029-10-31
Completion
2029-10-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06688695 on ClinicalTrials.gov