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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controll group | No Intervention | Standard care | |
| INSPIRE-intervention | Other | Intervention group, recieving the INSPIRE-intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Alberta infant motor scale (AIMS) | 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. | 6 months corrected age. |
| Peabody Developmental Motor Scales (PDMS-2) |
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Inclusion Criteria:
* Infant born before 32 GV, or with birth weight under 1500 gr.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Malin Bergman Papworth, PhD-student | Contact | 0046 730438397 | malin.bergman.papworth@umu.se |
| Name | Affiliation | Role |
|---|---|---|
| Magnus Domellöf, Professor | Umeå universitet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Falu County Hospital | Recruiting | Falun | Dalarna County | 791 82 | Sweden | |
| Östersund Hospital |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
Peabody Developmental Motor Scales (PDMS-2) is a test, administered by a physiotherapist, to assess motor function. |
| 24 months corrected age. |
| Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI IV) | 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. | 5,5 years of age |
| Movement ABC | Movement ABC is a test administered by a physiotherapist for assessment of motor development at 5.5 years of age. | 5,5 years of age |
| Strengths and Difficulties Questionnaire (SDQ) | Strengths and Difficulties Questionnaire (SDQ) is a parental questionnaire for assessment of behavioural problems | 24 months corrected age, 36 months of age and 5,5 years of age |
| The Infant Toddler Checklist (ITC) | The Infant Toddler Checklist (ITC) is a questionnaire/method to assess early language development | 18 months corrected age |
| The MacArthur-Bates Communicative Development Inventories (MB-CDIs) | The MacArthur-Bates Communicative Development Inventories (MB-CDIs) is a questionnaire/method to assess early language development. | 12 and 18 months corrected age. |
| "Jollerobservation" | "Jollerobservation" is a Swedish standardised protocol for observation of babbling. The observation is performed by a speech- and language pathologist. | 12 months corrected age. |
| The Montreal Children's Hospital Feeding Scale | The Montreal Children's Hospital Feeding Scale are a questionnaire that will be used for assessment of feeding development. | 12 months corrected age. |
| The Emotional Availability Scale (EAS) | 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 | 12 months corrected age and 24 months corrected age. |
| The Parental Reflective Functioning Questionnaire (PRFQ) | The Parental Reflective Functioning Questionnaire (PRFQ) will be used to assess parents reflective functioning regarding their child's emotional needs | 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. |
| Modified Checklist for Autism in Toddlers (M-CHAT | Modified Checklist for Autism in Toddlers (M-CHAT) is a parental questionnaire for assessment of early signs of autism | 24 months corrected age |
| The Reynell Developmental Language Scales IV (RDLS IV) | The Reynell Developmental Language Scales IV (RDLS IV) will be used for detailed assessment of language development. | 36 months of age. |
| Ages and Stages Questionnaire (ASQ) | Ages and Stages Questionnaire (ASQ) is a parental questionnaire for assessment of general neurodevelopment | 24 months corrected age |
| Swedish Parenthood Stress Questionnarie (SPSQ) | Swedish Parenthood Stress Questionnarie (SPSQ) is a questionnaire that measures stress. | 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) | Resilience Scale (RES) is a questionnaire that measures resilience. | 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) | Parental Self-Efficacy Scale (PSE) is a questionnaire that measures parental self efficacy. | 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 Hospital Anxiety and Depression scale (HAD) | The Hospital Anxiety and Depression scale (HAD) is a questionnaire that measures anxiety and depression. It will be used to assess parental mental health. | 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) | The State-Trait Anxiety Inventory (STAI) is a questionnaire that measures anxiety. It will be used to assess parental mental health. | At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age and 5,5 years of age. |
| Recruiting |
| Östersund |
| Jämtland Härjedalen |
| 831 83 |
| Sweden |
| Sunderby Hospital | Recruiting | Södra Sunderbyn | Norrbotten County | 954 42 | Sweden |
| Karlstad Hospital | Recruiting | Karlstad | Värmland County | 651 85 | Sweden |
| Umeå university hospital | Recruiting | Umeå | Västerbotten County | 90185 | Sweden |
|
| Sundsvall Hospital | Recruiting | Sundsvall | Västernorrland County | 856 43 | Sweden |
| Örebro University Hospital | Recruiting | Örebro | Örebro County | 701 15 | Sweden |
| D000091642 | Urogenital Diseases |