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

Abstract

Background: Improved neonatal care has resulted in increased survival rates among infants born after only 22 gestational weeks, but extremely preterm children still have an increased risk of neurodevelopmental delays, learning disabilities and reduced cognitive capacity, particularly executive function deficits. Parent-child interaction and parental mental health are associated with infant development, regardless of preterm birth. There is a need for further early interventions directed towards extremely preterm (EPT) children as well as their parents. The purpose of this paper is to describe the Stockholm Preterm Interaction-Based Intervention (SPIBI), the arrangements of the SPIBI trial and the chosen outcome measurements. Methods: The SPIBI is a randomized clinical trial that includes EPT infants and their parents upon discharge from four neonatal units in Stockholm, Sweden. Inclusion criteria are EPT infants soon to be discharged from a neonatal intensive care unit (NICU), with parents speaking Swedish or English. Both groups receive three initial visits at the neonatal unit before discharge during the recruitment process, with a strengths-based and development-supportive approach. The intervention group receives ten home visits and two telephone calls during the first year from a trained interventionist from a multiprofessional team. The SPIBI intervention is a strengths-based early intervention programme focusing on parental sensitivity to infant cues, enhancing positive parent-child interaction, improving self-regulating skills and supporting the infant's next small developmental step through a scaffolding process and parent-infant co-regulation. The control group receives standard follow-up and care plus extended assessment. The outcomes of interest are parent-child interaction, child development, parental mental health and preschool teacher evaluation of child participation, with assessments at 3, 12, 24 and 36 months corrected age (CA). The primary outcome is emotional availability at 12 months CA. Discussion: If the SPIBI shows positive results, it could be considered for clinical implementation for child-support, ethical and health-economic purposes. Regardless of the outcome, the trial will provide valuable information about extremely preterm children and their parents during infancy and toddlerhood after regional hospital care in Sweden. Trial registration: The study was registered in ClinicalTrials.gov in October 2018 (NCT03714633).

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

“…In this study, 43% of the families had at least one parent who was born outside of Sweden, which is quite a large proportion. Since one exclusion criteria of SPIBI is families where none of the parents speak Swedish or English [ 71 ], some of the families who recently immigrated to Sweden were initially excluded. Previous research has suggested that migrating to Sweden may increase the risk of giving birth preterm during the first year [ 88 ], a result partly confirmed by international data [ 89 ], even though clear conclusions are difficult to draw since the definition of migration is not standardized.…”

“…Hence, parental feelings as well as behavior are the central target in the theory of change of the SPIBI-intervention and not the infant behavior per se. With increased parental well-being, less stress and reinforced parental responsive interaction, the intervention is hypothesized to affect the dyadic interplay, parental mental health and the infant development, see protocol for more information [ 71 ].…”

“…The intention of both interview guides was to get an idea of how the first year at home was perceived, as well as to ask follow-up questions to the parents’ answers when applicable. The questions for the intervention group parents concerned the intervention and aimed to give a broader picture of parental perceptions compared to the client-satisfaction questionnaire CSQ-8 [ 75 ], which was distributed during the 12-month home-visit [ 71 ]. The general questions concerned parental perception of the first year at home, queries about the support received, and if parents required more or different types of support.…”

“…We do not intend to evaluate the effects of the randomized controlled study (RCT) in the current study, since qualitative outcomes were not a predefined outcome [ 71 ].…”

Educational Methods to Improve the Ability of Parents to Provide Developmental Care For Premature Infants: A Literatur Review

“…The results of the literature study obtained several sustainable education and monitoring methods, including Stockholm preterm interaction-based intervention (SPIBI) (15) and Creating Opportunities for Parent Empowerment (COPE). Stockholm preterm interaction-based intervention (SPIBI) (15), is one of the methods used to improve people's ability to provide developmental care.…”