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

NCT06688695 | Recruiting

• 1 other identifier: EPM Dnr 2024-03048-01
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 7

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

Conditions

Premature Infant; Premature Babies

Keywords

Early intervention; Responsive parenting; E-health; Prematurity

Outcome Measures

Primary Outcomes (1)

• Bayley Scales of Infant Development (BSID IV)

  Bayley Scales of Infant Development (BSID IV) is a test administered by a psychologist for assessment of general neurodevelopment (cognitive, language and motor) at 24 months corrected age (primary outcome)

  24 months corrected age

Secondary Outcomes (19)

• Alberta infant motor scale (AIMS)

  6 months corrected age.

• Peabody Developmental Motor Scales (PDMS-2)

  24 months corrected age.

• Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI IV)

  5,5 years of age

• Movement ABC

  5,5 years of age

• Strengths and Difficulties Questionnaire (SDQ)

  24 months corrected age, 36 months of age and 5,5 years of age

Study Arms (2)

Controll group

NO INTERVENTION

Standard care

INSPIRE-intervention

OTHER

Intervention group, recieving the INSPIRE-intervention

Behavioral: Neurodevelopmental support

Interventions

Neurodevelopmental support BEHAVIORAL

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.

INSPIRE-intervention

Eligibility Criteria

• Age: 0 Months - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Umeå University: lead

Study Sites (7)

Falu County Hospital

Falun, Dalarna County, 791 82, Sweden

RECRUITING

Östersund Hospital

Östersund, Jämtland Härjedalen, 831 83, Sweden

RECRUITING

Sunderby Hospital

Södra Sunderbyn, Norrbotten County, 954 42, Sweden

RECRUITING

Karlstad Hospital

Karlstad, Värmland County, 651 85, Sweden

RECRUITING

Umeå university hospital

Umeå, Västerbotten County, 90185, Sweden

RECRUITING

Sundsvall Hospital

Sundsvall, Västernorrland County, 856 43, Sweden

RECRUITING

Örebro University Hospital

Örebro, Örebro County, 701 15, Sweden

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Magnus Domellöf, Professor

  Umeå universitet

  STUDY DIRECTOR

Central Study Contacts

Malin Bergman Papworth, PhD-student

CONTACT

0046 730438397; malin.bergman.papworth@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: November 14, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (7)