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Extreme PrematuritySPIBINCT03714633

Stockholm Preterm Interaction-Based Intervention

A study testing Stockholm Preterm Interaction-Based Intervention (SPIBI) in people with Extreme Prematurity, run by Stockholm University at 5 sites in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 32 to 45 weeks
Conditions the study is for
Extreme Prematurity
What is being tested?
Stockholm Preterm Interaction-Based Intervention (SPIBI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
5 sitesSweden
Study dates
1 Sep 2018to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

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 32 to 45 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Sweden5 sites

  • Karolinska Hospital, Danderyds Sjukhus neonatalavdelning

    Danderyd, 18288

  • Karolinska Hospital Huddinge, neontalavdelningen

    Huddinge, 14186

  • Karolinska Hospital

    Solna, 171 76

  • Stockholm University

    Stockholm, 10691

  • Södersjukhusets neonatalavdelning

    Stockholm, 11883

Other trials in Sweden

About this study

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.

Read the 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.

Being tested
Stockholm Preterm Interaction-Based Intervention (SPIBI)
Keywords
cognitive development, motor development, parent-child interaction, parental mental health, strength-based intervention, 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.

  • Stockholm Preterm Interaction-Based Intervention (SPIBI)Behavioural

    Post-discharge intervention to extreme premature infants and their parents

Study groups in NCT03714633
Study groupRoleWhat they receive
Stockholm Preterm Interaction-Based Intervention (SPIBI)ExperimentalHome-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.
Receives: Behavioral: Stockholm Preterm Interaction-Based Intervention (SPIBI)
ControlNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parent-child interaction

    Emotional availability scales, EAS The scale has four parental dimensions; sensitivity, structure, non-intrusiveness, non-hostility and two child dimensions; child responsiveness and child involvement. Each subscale has a maximum score of 29 and a direct score of 1-7. Hypothesis of higher scores in intervention group.

    Measured: 12 months corrected age.

Secondary outcomes (7)

  1. Child's general development

    Bayley scales of infant and toddler development (third edition; Bayley-III), measuring cognition, language, and motor development. Composite scores are standardized to mean (SD) scores of 100 (15), based on age-matched normative data. Higher scores in intervention group

    Measured: 24 months corrected age

  2. Child's executive function

    Behaviour Rating of Executive Function Parental version BRIEF-P. All the 5 subscales will be used. Hypothesis of less executive problems in intervention group.

    Measured: 24 and 36 months corrected age

  3. Child's motor development 1

    Alberta Infant Motor Scale, AIMS. Range 0 - 58 points, with a hypothesis of higher scores for intervention group

    Measured: 3 months & 12 months corrected age

  4. Parental depression

    Hospital anxiety and depression scale, HADS. Range depression subscale 0-21, range anxiety subscale 0-21. Hypothesis of lower scores in the intervention-parental group.

    Measured: Term age, 12, 24 and 36 months corrected age

  5. Parental anxiety

    State/trait anxiety inventory, STAI. Maximum 80 points for the State-scale, and maximum 80 points for the trait-scale. Hypothesis of lower scores in the intervention-parental group

    Measured: Term age, 12, 24 and 36 months corrected age

  6. Parental self-efficacy

    parental self-efficacy scale, PSE. PSE has 24 items at term age and 12 and 24 months and 48 items int he form for older ages, all items rated in a 0-10 scale. Hypothesis of higher score for intervention group at 12,24 and 36 months.

    Measured: Term age, 12, 24 and 36 months corrected age

  7. Parental resilience

    Resilience scale, RES. RES is a 25-items scale with a 7-point Likert scale. Hypothesis of higher scores in the intervention group.

    Measured: Term age, 12, 24 and 36 months corrected age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2018
  2. Study start1 Sep 2018
  3. Primary completion3 Jan 2023
  4. Study completion31 Dec 2024 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03714633
Sponsor's protocol ID
TiSam
Acronym
SPIBI
Status last verified
Apr 2024
First submitted
26 Sep 2018
Last updated
22 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22406323

  • 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.

    PubMed 18783797

  • 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.

    PubMed 19880139

  • 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.

    PubMed 20645992

  • 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.

    PubMed 26597166

  • 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.

    PubMed 32007087

  • 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

  • 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.

    PubMed 33322234

Questions about this trial

What is this clinical trial studying?

A study testing Stockholm Preterm Interaction-Based Intervention (SPIBI) in people with Extreme Prematurity, run by Stockholm University at 5 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parent-child interaction (time frame: 12 months corrected age.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03714633, which also lists 8 linked publications.

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 22 Apr 2024.

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