Premature InfantINSPIRENCT06688695
Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health
A study testing Neurodevelopmental support in people with Premature Infant and Premature Babies, run by Umeå University at 7 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 4 months
- Conditions the study is for
- Premature Infant, Premature Babies
- What is being tested?
- Neurodevelopmental support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 7 sitesSweden
- Study dates
- 20 Nov 2024to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant born before 32 GV, or with birth weight under 1500 gr.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Sweden7 sites, 7 recruiting
- Recruiting
Falu County Hospital
Falun, Dalarna County, 791 82
- Recruiting
Karlstad Hospital
Karlstad, Värmland County, 651 85
- Recruiting
Örebro University Hospital
Örebro, Örebro County, 701 15
- Recruiting
Östersund Hospital
Östersund, Jämtland Härjedalen, 831 83
- Recruiting
Sunderby Hospital
Södra Sunderbyn, Norrbotten County, 954 42
- Recruiting
Sundsvall Hospital
Sundsvall, Västernorrland County, 856 43
- Recruiting
Umeå university hospital
Umeå, Västerbotten County, 90185
Malin C Bergman Papworth, PhD student, +46730438397
About this study
Official title: Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health (INSPIRE)
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.
Read more
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
- Being tested
- Neurodevelopmental support
- Keywords
- Early intervention, Responsive parenting, E-health, Prematurity
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodevelopmental supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Controll group | No intervention | Standard care |
| INSPIRE-intervention | Other | Intervention group, recieving the INSPIRE-intervention Receives: Behavioral: Neurodevelopmental support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 months corrected age
Secondary outcomes (19)
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.
Measured: 6 months corrected age.
Peabody Developmental Motor Scales (PDMS-2)
Peabody Developmental Motor Scales (PDMS-2) is a test, administered by a physiotherapist, to assess motor function.
Measured: 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.
Measured: 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.
Measured: 5,5 years of age
Strengths and Difficulties Questionnaire (SDQ)
Strengths and Difficulties Questionnaire (SDQ) is a parental questionnaire for assessment of behavioural problems
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 36 months of age.
Ages and Stages Questionnaire (ASQ)
Ages and Stages Questionnaire (ASQ) is a parental questionnaire for assessment of general neurodevelopment
Measured: 24 months corrected age
Swedish Parenthood Stress Questionnarie (SPSQ)
Swedish Parenthood Stress Questionnarie (SPSQ) is a questionnaire that measures stress.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age and 5,5 years of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start20 Nov 2024
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magnus Domellöf, Professor, Study director, Umeå universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688695
- Sponsor's protocol ID
- EPM Dnr 2024-03048-01
- Acronym
- INSPIRE
- Status last verified
- Jan 2026
- First submitted
- 3 Oct 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health (INSPIRE)
- ClinicalTrials.gov ID
- NCT06688695
- Acronym / sponsor ID
- INSPIRE / EPM Dnr 2024-03048-01
- Conditions
- Premature Infant, Premature Babies
- Keywords
- Early intervention, Responsive parenting, E-health, Prematurity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controll group | No intervention | –Standard care |
| INSPIRE-intervention | Other | Behavioral: Neurodevelopmental supportIntervention group, recieving the INSPIRE-intervention |
Who may qualify
- Ages
- 0 to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infant born before 32 GV, or with birth weight under 1500 gr.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurodevelopmental supportThe 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. | Behavioural | INSPIRE-intervention |
Primary outcome
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)
19 secondary outcomes
Alberta infant motor scale (AIMS)
Time frame: 6 months corrected age.
Peabody Developmental Motor Scales (PDMS-2)
Time frame: 24 months corrected age.
Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI IV)
Time frame: 5,5 years of age
Movement ABC
Time frame: 5,5 years of age
Strengths and Difficulties Questionnaire (SDQ)
Time frame: 24 months corrected age, 36 months of age and 5,5 years of age
The Infant Toddler Checklist (ITC)
Time frame: 18 months corrected age
The MacArthur-Bates Communicative Development Inventories (MB-CDIs)
Time frame: 12 and 18 months corrected age.
"Jollerobservation"
Time frame: 12 months corrected age.
The Montreal Children's Hospital Feeding Scale
Time frame: 12 months corrected age.
The Emotional Availability Scale (EAS)
Time frame: 12 months corrected age and 24 months corrected age.
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.
Modified Checklist for Autism in Toddlers (M-CHAT
Time frame: 24 months corrected age
The Reynell Developmental Language Scales IV (RDLS IV)
Time frame: 36 months of age.
Ages and Stages Questionnaire (ASQ)
Time frame: 24 months corrected age
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.
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.
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.
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 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magnus Domellöf, Professor study director
Umeå universitet
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurodevelopmental support in people with Premature Infant and Premature Babies, run by Umeå University at 7 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malin Bergman Papworth, PhD-student (0046 730438397, malin.bergman.papworth@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley Scales of Infant Development (BSID IV) (time frame: 24 months corrected age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.