Stockholm Preterm Interaction-Based Intervention

Summary

Extreme premature Children will at discharge from Karolinska Hospital and Södersjukhuset in Stockholm be asked to participate in a study, examining the effects of a home-visit based post-discharge program aiming at facilitating the interaction between infants and parents, improving the development of the children, and the parental mental health. The study is a randomized controlled Trial (RCT), hence 50% of the participants will be offered treatment as usual (TAU) with addition of an extended follow-up program. The interaction-based program consists of one initial visit at the hospital followed by nine home-visits and two telephone calls during the child's first year of life. The interventionists are skilled Healthcare professionals with several years of experience from caring for premature infants and their parents. All interventionists have successfully completed a one year further education program, delivered one day per week and containing theoretical lectures, practice with actual cases, supervision on the cases, visits to the different parts of the neonatal care chain and discussions with a representative from the premature family association Sweden.

Conditions

• Extreme Prematurity

Interventions

BEHAVIORAL

Stockholm Preterm Interaction-Based Intervention (SPIBI)

Post-discharge intervention to extreme premature infants and their parents

Sponsors & Collaborators

• Karolinska Institutet

  collaborator OTHER

• Region Stockholm

  collaborator OTHER_GOV

• Centrum för kompetensutveckling inom vård och omsorg, Stockholm University (funding)

  collaborator UNKNOWN

• Clas Groschinskys Minnesfond, Sweden (funding)

  collaborator UNKNOWN

• Queen Silvia Jubilee Fund for research on children and disability, Sweden (funding)

  collaborator UNKNOWN

• Filénska fonden, Sweden (funding)

  collaborator UNKNOWN

• Stockholm University

  lead OTHER

Principal Investigators

• Ulrika Ådén, MD PhD · Karolinska Institutet

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

32 Weeks

Max Age

45 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-01

Primary Completion

2023-01-03

Completion

2024-12-31

Countries

• Sweden

Study Locations