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ACTIVE NOT RECRUITING
NCT03714633
NA

Stockholm Preterm Interaction-Based Intervention

Sponsor: Stockholm University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

32 Weeks - 45 Weeks

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2018-09-01

Completion Date

2024-12-31

Last Updated

2024-04-22

Healthy Volunteers

No

Interventions

BEHAVIORAL

Stockholm Preterm Interaction-Based Intervention (SPIBI)

Post-discharge intervention to extreme premature infants and their parents

Locations (5)

Karolinska Hospital, Danderyds Sjukhus neonatalavdelning

Danderyd, Sweden

Karolinska Hospital Huddinge, neontalavdelningen

Huddinge, Sweden

Karolinska Hospital

Solna, Sweden

Stockholm University

Stockholm, Sweden

Södersjukhusets neonatalavdelning

Stockholm, Sweden