Actively Recruiting

Phase Not Applicable
Age: 0Months - 4Months
All Genders
ID06688695

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

Led by Umeå University · Updated on 2026-01-28

176

Participants Needed

7

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating a new e-health program designed to improve the neurodevelopment of very preterm infants, born before 32 weeks or with low birth weight, by supporting parents in responsive caregiving. The study aims to see if this program, called INSPIRE, can enhance cognitive, motor, feeding, language, and socio-emotional development up to 2 years of age. Additional goals include assessing parental stress, emotional availability, health inequalities, and gender differences. This trial is conducted by Umeå University with a multi-professional team and builds on a pilot study involving nine families. The intervention group will receive the INSPIRE program, which consists of 18 sessions delivered digitally over two years, starting at hospital discharge. This program focuses on strengthening parent-child interactions and empowering parents with responsive parenting skills. Families in the control group will receive standard care without the INSPIRE intervention. The study randomly assigns families to either group and follows up with assessments over time. Participants will be involved from discharge through at least 2 years corrected age, with evaluations including neurodevelopmental tests such as the Bayley Scales of Infant Development at 24 months. Additional assessments cover motor skills, language, feeding, emotional availability, parental stress, and mental health using various standardized tools at multiple time points up to 5.5 years of age. Researchers will monitor child development, parent well-being, and other outcomes to understand the intervention's impact and safety over the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0Months - 4Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infant born before 32 weeks gestational age or with a birth weight under 1500 grams
  • Parents able to understand Swedish
  • Parents aged 18 years or older
  • Infant younger than 4 months old
Not Eligible

You will not qualify if you...

  • Parent(s) younger than 18 years old
  • Chromosomal abnormalities or congenital syndromes affecting development
  • Parents unable to understand Swedish
  • Parents with severe mental illness or physical conditions requiring extensive inpatient care
  • Families without a stable living situation, such as substance abuse, homelessness, or threat of deportation
  • Families that have previously participated in the INSPIRE study or pilot study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Up to 24 months corrected age

Participants receive the INSPIRE behavioral intervention aimed at supporting infant neurodevelopment through responsive parenting and e-health methods.

Regular visits scheduled during the intervention period

Follow-up

Duration - Up to 5.5 years of age

Participants are monitored at multiple time points up to 5.5 years to assess neurodevelopmental outcomes and parental wellbeing.

Multiple follow-up visits at 6 months, 12 months, 18 months, 24 months, 36 months, and 5.5 years

Trial Site Locations

Total: 7 locations

1

Falu County Hospital

Falun, Dalarna County, Sweden, 791 82

Actively Recruiting

2

Östersund Hospital

Östersund, Jämtland Härjedalen, Sweden, 831 83

Actively Recruiting

3

Sunderby Hospital

Södra Sunderbyn, Norrbotten County, Sweden, 954 42

Actively Recruiting

4

Karlstad Hospital

Karlstad, Värmland County, Sweden, 651 85

Actively Recruiting

5

Umeå university hospital

Umeå, Västerbotten County, Sweden, 90185

Actively Recruiting

6

Sundsvall Hospital

Sundsvall, Västernorrland County, Sweden, 856 43

Actively Recruiting

7

Örebro University Hospital

Örebro, Örebro County, Sweden, 701 15

Actively Recruiting

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Research Team

M

Malin Bergman Papworth, PhD-student

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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