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
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
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DOI：
10.1186/s12887-020-1934-4
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发表时间：
2020-02-01
期刊：
影响因子：
2.4
通讯作者：
Aden, Ulrika
中科院分区：
文献类型：
--
作者：
Baraldi, Erika;Allodi, Mara Westling;Aden, Ulrika
背景：新生儿护理的改善提高了22周后出生的婴儿的存活率，但极早产儿神经发育迟缓、学习障碍和认知能力降低的风险仍然增加，特别是执行功能缺陷。亲子互动和父母心理健康与婴儿发育有关，与早产无关。需要针对极早产(EPT)儿童及其父母进行进一步的早期干预。本文的目的是描述斯德哥尔摩早产相互作用干预(SPIBI)，SPIBI试验的安排和所选择的结果测量。方法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的EPT婴儿及其父母。纳入标准是即将从新生儿重症监护病房(NICU)出院的EPT婴儿，父母说瑞典语或英语。在招募过程中，两组在出院前都会在新生儿病房接受三次初步探视，采取基于优势和支持发展的方法。干预小组在第一年收到了10次家访和两个电话，来自一个多专业团队的训练有素的干预者。SPIBI干预是一项以优势为基础的早期干预计划，重点是父母对婴儿暗示的敏感性，加强亲子之间的积极互动，提高自我调节技能，并通过脚手架过程和亲婴共同调节支持婴儿下一小步的发展。对照组接受标准的随访和护理，外加扩展评估。感兴趣的结果是亲子互动、儿童发展、父母心理健康和幼儿教师对儿童参与的评估，评估在3个月、12个月、24个月和36个月校正年龄(CA)。主要结果是在12个月CA时的情绪可获得性。讨论如果SPIBI显示出积极的结果，可以考虑将其用于儿童抚养、伦理和卫生经济目的的临床实施。无论结果如何，这项试验都将提供有关极早产儿及其父母在瑞典地区医院护理后的婴儿期和蹒跚学步时期的有价值的信息。
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 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. 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.