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NCT Number: NCT06688695

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

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

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Key information

Conditions

Premature Infant Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Babies Premature Birth Urogenital Diseases

Age range

0 month–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Falu County Hospital, Falun, Dalarna County, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Bayley Scales of Infant Development (BSID IV)

    Time frame: 24 months corrected age

    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)

Secondary outcomes

  1. Alberta infant motor scale (AIMS)

    Time frame: 6 months corrected age.

    Alberta infant motor scale is a test performed by a physiotherapist, based on live observation or a video recording of the infant. We will use video recordings.

  2. Peabody Developmental Motor Scales (PDMS-2)

    Time frame: 24 months corrected age.

    Peabody Developmental Motor Scales (PDMS-2) is a test, administered by a physiotherapist, to assess motor function.

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

    Time frame: 5,5 years of age

    Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI IV) is a test performed by a psychologist for assessment of cognitive development at 5.5 years of age.

  4. Movement ABC

    Time frame: 5,5 years of age

    Movement ABC is a test administered by a physiotherapist for assessment of motor development at 5.5 years of age.

  5. Strengths and Difficulties Questionnaire (SDQ)

    Time frame: 24 months corrected age, 36 months of age and 5,5 years of age

    Strengths and Difficulties Questionnaire (SDQ) is a parental questionnaire for assessment of behavioural problems

  6. The Infant Toddler Checklist (ITC)

    Time frame: 18 months corrected age

    The Infant Toddler Checklist (ITC) is a questionnaire/method to assess early language development

  7. The MacArthur-Bates Communicative Development Inventories (MB-CDIs)

    Time frame: 12 and 18 months corrected age.

    The MacArthur-Bates Communicative Development Inventories (MB-CDIs) is a questionnaire/method to assess early language development.

  8. "Jollerobservation"

    Time frame: 12 months corrected age.

    "Jollerobservation" is a Swedish standardised protocol for observation of babbling. The observation is performed by a speech- and language pathologist.

  9. The Montreal Children's Hospital Feeding Scale

    Time frame: 12 months corrected age.

    The Montreal Children's Hospital Feeding Scale are a questionnaire that will be used for assessment of feeding development.

  10. The Emotional Availability Scale (EAS)

    Time frame: 12 months corrected age and 24 months corrected age.

    The Emotional Availability Scale (EAS) is an observational coding system to assess emotional availability during caregiver-infant interactions regarding both the parent and the child

  11. The Parental Reflective Functioning Questionnaire (PRFQ)

    Time frame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age, 24 months corrected age, and 36 months of age and 5,5 years of age.

    The Parental Reflective Functioning Questionnaire (PRFQ) will be used to assess parents reflective functioning regarding their child's emotional needs

  12. Modified Checklist for Autism in Toddlers (M-CHAT

    Time frame: 24 months corrected age

    Modified Checklist for Autism in Toddlers (M-CHAT) is a parental questionnaire for assessment of early signs of autism

  13. The Reynell Developmental Language Scales IV (RDLS IV)

    Time frame: 36 months of age.

    The Reynell Developmental Language Scales IV (RDLS IV) will be used for detailed assessment of language development.

  14. Ages and Stages Questionnaire (ASQ)

    Time frame: 24 months corrected age

    Ages and Stages Questionnaire (ASQ) is a parental questionnaire for assessment of general neurodevelopment

  15. Swedish Parenthood Stress Questionnarie (SPSQ)

    Time frame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age, 24 months corrected age, and 36 months of age and 5,5 years of age.

    Swedish Parenthood Stress Questionnarie (SPSQ) is a questionnaire that measures stress.

  16. Resilience Scale (RES)

    Time frame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age, 24 months corrected age, and 36 months of age and 5,5 years of age.

    Resilience Scale (RES) is a questionnaire that measures resilience.

  17. Parental Self-Efficacy Scale (PSE)

    Time frame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age, 24 months corrected age, and 36 months of age and 5,5 years of age.

    Parental Self-Efficacy Scale (PSE) is a questionnaire that measures parental self efficacy.

  18. The Hospital Anxiety and Depression scale (HAD)

    Time frame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age and 5,5 years of age.

    The Hospital Anxiety and Depression scale (HAD) is a questionnaire that measures anxiety and depression. It will be used to assess parental mental health.

  19. The State-Trait Anxiety Inventory (STAI)

    Time frame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age and 5,5 years of age.

    The State-Trait Anxiety Inventory (STAI) is a questionnaire that measures anxiety. It will be used to assess parental mental health.

Study contacts

Contact information is provided by the study sponsor or research team.

Malin Bergman Papworth, PhD-student

CONTACT

[email protected]

0046 730438397

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

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

Acronym: INSPIRE

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Nov 14, 2024
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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