Baraldi Erika, Allodi Mara Westling, Löwing Kristina, Smedler Ann-Charlotte, Westrup Björn, Ådén Ulrika
Department of Special Education, Specialpedagogiska institutionen Stockholms universitet, Stockholm University, Frescati Hagväg 10, 106 91, Stockholm, Sweden.
Department of Women's and Children's Health, Institutionen för kvinnors och barns hälsa, Karolinska Institutet, Karolinska Institutet, 171 77, Stockholm, Sweden.
BMC Pediatr. 2020 Feb 1;20(1):49. doi: 10.1186/s12887-020-1934-4.
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.
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 multi-professional 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.
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.
The study was registered in ClinicalTrials.gov in October 2018 (NCT03714633).
新生儿护理的改善使得孕22周后出生的婴儿存活率有所提高,但极早产儿仍有神经发育延迟、学习障碍和认知能力下降的风险增加,尤其是执行功能缺陷。亲子互动和父母心理健康与婴儿发育相关,无论是否早产。需要对极早产儿及其父母进行进一步的早期干预。本文旨在描述斯德哥尔摩基于互动的早产干预(SPIBI)、SPIBI试验的安排以及所选择的结局测量指标。
SPIBI是一项随机临床试验,纳入瑞典斯德哥尔摩四个新生儿病房出院时的极早产儿及其父母。纳入标准是即将从新生儿重症监护病房(NICU)出院的极早产儿,其父母说瑞典语或英语。两组在招募过程中在出院前于新生儿病房接受三次初始访视,采用基于优势和支持发育的方法。干预组在第一年接受来自多专业团队的经过培训的干预人员进行的十次家访和两次电话随访。SPIBI干预是一项基于优势的早期干预计划,侧重于父母对婴儿线索的敏感性,增强积极的亲子互动,提高自我调节技能,并通过支架过程和亲子共同调节支持婴儿的下一个小的发育步骤。对照组接受标准的随访和护理以及扩展评估。感兴趣的结局是亲子互动、儿童发育、父母心理健康以及学前教师对儿童参与情况的评估,在矫正年龄(CA)3、12、24和36个月时进行评估。主要结局是矫正年龄12个月时的情感可及性。
如果SPIBI显示出积极结果,出于儿童支持、伦理和健康经济目的,可考虑将其用于临床实施。无论结果如何,该试验将为瑞典地区医院护理后婴儿期和幼儿期的极早产儿及其父母提供有价值的信息。
该研究于2018年10月在ClinicalTrials.gov注册(NCT03714633)。