Stockholm Preterm Interaction-Based Intervention

NCT ID: NCT03714633

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2024-12-31

Brief 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.

Detailed Description

Detailed description of the intervention: the purpose of the initial visit at the neonatal unit or hospital ward where the child is still treated is to establish the foundation for the interventionist/family relationship and give the parent(-s) the opportunity to show the interventionist the environment where the infant has spent his/her first 3-5 months in life.

Home-visit 1-3 and two telephone calls are provided before the child is three months corrected age. The focus of these home visits is to observe child and parent at home and validate the child's strengths and competences as well as enhancing the parent-child interaction, building on strengths. The child's strengths and interests will be summarized in a logbook owned by the parents. During home-visit 4-8 the interventionist, step by step and always with great regard to the child's level of development, will support the parent in using the home-environment in a developmental supporting manner for the child, find suitable objects/toys at home for the child to examine with mouth, hands and body, confirm the child's abilities and give suggestions on how to stimulate the child's further development. The logbook will now also contain suggestions for supporting the next developmental step, which will be formulated by the interventionist together with the parent. The ninth and last home-visit will emphasize the child's progress during the past year, look through the family logbook and both summarize the past year and talk about the next developmental step for the future.

The intervention group receives the standard follow-up program just as the control group and will be referred to specialized care when needed. Compared to children not participating in the study, the study participants will receive an extended follow-up program, with assessment and questionnaires at term age, 3 months corrected age, 12 months corrected age, 24 months corrected age and 36 months corrected age. The research process and the study protocol have been published, see references below.

Conditions

Extreme Prematurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Stockholm Preterm Interaction-Based Intervention (SPIBI)

Home-based post-discharge intervention for extreme premature babies and their parents. The intervention consists of one hospital visit, nine home-visits and two telephone calls during the first year corrected age, specifically from one week before discharge to 12 months corrected age. The intervention is strengths-based working with the infant-parent interaction, supporting infant development and strengthening the parent in his/her role.

Group Type: EXPERIMENTAL

Stockholm Preterm Interaction-Based Intervention (SPIBI)

Intervention Type: BEHAVIORAL

Post-discharge intervention to extreme premature infants and their parents

Control

The participants of the Control Group receives treatment as usual, which consists of a regular follow-up program with neurodevelopmental assessment at term age, 3 months corrected age, 12 months corrected age, 24 months corrected age and 66 months corrected age. Compared to children not participating in the study, the control group will receive an extended follow-up program, with assessment and questionnaires at term age, 3 months corrected age, 12 months corrected age, 24 months corrected age and 36 months corrected age. Participants in the control group will be referred to specialized care when needed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Stockholm Preterm Interaction-Based Intervention (SPIBI)

Post-discharge intervention to extreme premature infants and their parents

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• extremely premature born babies
• close to discharge from their neonatal intensive care unit hospital stay at Stockholm county council (Stockholms Läns Landsting).

Exclusion Criteria

• Children with parent/parents who do not communicate in Swedish or English.
• Patients not residing in Stockholm county.
• Acute surgery patients who will spend a lot of time at hospitals far from Stockholm

• Minimum Eligible Age: 32 Weeks
• Maximum Eligible Age: 45 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

Clas Groschinskys Minnesfond, Sweden (funding)

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

Filénska fonden, Sweden (funding)

UNKNOWN

Sponsor Role: collaborator

Stockholm University

OTHER

Sponsor Role: lead

Responsible Party

Professor Mara Westling Allodi

Professor in Special Education

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulrika Ådén, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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

Countries

Sweden

References

Verkerk G, Jeukens-Visser M, Houtzager B, Koldewijn K, van Wassenaer A, Nollet F, Kok J. The infant behavioral assessment and intervention program in very low birth weight infants; outcome on executive functioning, behaviour and cognition at preschool age. Early Hum Dev. 2012 Aug;88(8):699-705. doi: 10.1016/j.earlhumdev.2012.02.004. Epub 2012 Mar 10.

Reference Type: BACKGROUND

PMID: 22406323 (View on PubMed)

Koldewijn K, Wolf MJ, van Wassenaer A, Meijssen D, van Sonderen L, van Baar A, Beelen A, Nollet F, Kok J. The Infant Behavioral Assessment and Intervention Program for very low birth weight infants at 6 months corrected age. J Pediatr. 2009 Jan;154(1):33-38.e2. doi: 10.1016/j.jpeds.2008.07.039. Epub 2008 Sep 10.

Reference Type: BACKGROUND

PMID: 18783797 (View on PubMed)

Koldewijn K, van Wassenaer A, Wolf MJ, Meijssen D, Houtzager B, Beelen A, Kok J, Nollet F. A neurobehavioral intervention and assessment program in very low birth weight infants: outcome at 24 months. J Pediatr. 2010 Mar;156(3):359-65. doi: 10.1016/j.jpeds.2009.09.009. Epub 2009 Nov 2.

Reference Type: BACKGROUND

PMID: 19880139 (View on PubMed)

Meijssen DE, Wolf MJ, Koldewijn K, van Wassenaer AG, Kok JH, van Baar AL. Parenting stress in mothers after very preterm birth and the effect of the Infant Behavioural Assessment and Intervention Program. Child Care Health Dev. 2011 Mar;37(2):195-202. doi: 10.1111/j.1365-2214.2010.01119.x.

Reference Type: BACKGROUND

PMID: 20645992 (View on PubMed)

Spittle A, Orton J, Anderson PJ, Boyd R, Doyle LW. Early developmental intervention programmes provided post hospital discharge to prevent motor and cognitive impairment in preterm infants. Cochrane Database Syst Rev. 2015 Nov 24;2015(11):CD005495. doi: 10.1002/14651858.CD005495.pub4.

Reference Type: BACKGROUND

PMID: 26597166 (View on PubMed)

Baraldi E, Allodi MW, Lowing K, Smedler AC, Westrup B, Aden U. Stockholm preterm interaction-based intervention (SPIBI) - study protocol for an RCT of a 12-month parallel-group post-discharge program for extremely preterm infants and their parents. BMC Pediatr. 2020 Feb 1;20(1):49. doi: 10.1186/s12887-020-1934-4.

Reference Type: BACKGROUND

PMID: 32007087 (View on PubMed)

Baraldi, E., Westling Allodi, M., Löwing, K., Smedler, A.-C., Westrup, B., & Ådén, U. (2019). Clinical Protocol & Research Process of Stockholm Preterm Interaction-Based Intervention, SPIBI. Pediatric Research, 86(Suppl.), 54-55. https://doi.org/10.1038/s41390-019-0521-6

Reference Type: BACKGROUND

Baraldi E, Allodi MW, Smedler AC, Westrup B, Lowing K, Aden U. Parents' Experiences of the First Year at Home with an Infant Born Extremely Preterm with and without Post-Discharge Intervention: Ambivalence, Loneliness, and Relationship Impact. Int J Environ Res Public Health. 2020 Dec 13;17(24):9326. doi: 10.3390/ijerph17249326.

Reference Type: RESULT

PMID: 33322234 (View on PubMed)

Related Links

https://www.su.se/english/research/research-projects/stockholm-preterm-interaction-based-intervention-spibi?open-collapse-boxes=research-project-publications,research-project-members,research-project-description

Link to project information

Other Identifiers

TiSam

Identifier Type: -

Identifier Source: org_study_id