Benzies Karen M, Aziz Khalid, Shah Vibhuti, Faris Peter, Isaranuwatchai Wanrudee, Scotland Jeanne, Larocque Jill, Mrklas Kelly J, Naugler Christopher, Stelfox H Thomas, Chari Radha, Soraisham Amuchou Singh, Akierman Albert Richard, Phillipos Ernest, Amin Harish, Hoch Jeffrey S, Zanoni Pilar, Kurilova Jana, Lodha Abhay
Faculty of Nursing, University of Calgary, Calgary, AB, T2N 1N4, Canada.
Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
BMC Pediatr. 2020 Nov 28;20(1):535. doi: 10.1186/s12887-020-02438-6.
Parents of infants in neonatal intensive care units (NICUs) are often unintentionally marginalized in pursuit of optimal clinical care. Family Integrated Care (FICare) was developed to support families as part of their infants' care team in level III NICUs. We adapted the model for level II NICUs in Alberta, Canada, and evaluated whether the new Alberta FICare™ model decreased hospital length of stay (LOS) in preterm infants without concomitant increases in readmissions and emergency department visits.
In this pragmatic cluster randomized controlled trial conducted between December 15, 2015 and July 28, 2018, 10 level II NICUs were randomized to provide Alberta FICare™ (n = 5) or standard care (n = 5). Alberta FICare™ is a psychoeducational intervention with 3 components: Relational Communication, Parent Education, and Parent Support. We enrolled mothers and their singleton or twin infants born between 32 and 34 weeks gestation. The primary outcome was infant hospital LOS. We used a linear regression model to conduct weighted site-level analysis comparing adjusted mean LOS between groups, accounting for site geographic area (urban/regional) and infant risk factors. Secondary outcomes included proportions of infants with readmissions and emergency department visits to 2 months corrected age, type of feeding at discharge, and maternal psychosocial distress and parenting self-efficacy at discharge.
We enrolled 654 mothers and 765 infants (543 singletons/111 twin cases). Intention to treat analysis included 353 infants/308 mothers in the Alberta FICare™ group and 365 infants/306 mothers in the standard care group. The unadjusted difference between groups in infant hospital LOS (1.96 days) was not statistically significant. Accounting for site geographic area and infant risk factors, infant hospital LOS was 2.55 days shorter (95% CI, - 4.44 to - 0.66) in the Alberta FICare™ group than standard care group, P = .02. Secondary outcomes were not significantly different between groups.
Alberta FICare™ is effective in reducing preterm infant LOS in level II NICUs, without concomitant increases in readmissions or emergency department visits. A small number of sites in a single jurisdiction and select group infants limit generalizability of findings.
ClinicalTrials.gov Identifier NCT02879799 , retrospectively registered August 26, 2016.
在新生儿重症监护病房(NICU)中,为追求最佳临床护理,婴儿的父母常常在无意间被边缘化。家庭综合护理(FICare)旨在支持家庭成为三级NICU中婴儿护理团队的一部分。我们对该模式进行了调整,以适用于加拿大艾伯塔省的二级NICU,并评估新的艾伯塔FICare™模式是否能缩短早产儿的住院时间(LOS),同时不会增加再次入院率和急诊就诊率。
在2015年12月15日至2018年7月28日进行的这项实用整群随机对照试验中,10个二级NICU被随机分为提供艾伯塔FICare™(n = 5)或标准护理(n = 5)两组。艾伯塔FICare™是一种包含三个组成部分的心理教育干预措施:关系沟通、家长教育和家长支持。我们纳入了妊娠32至34周出生的单胎或双胎婴儿的母亲。主要结局是婴儿的住院时间。我们使用线性回归模型进行加权的机构层面分析,比较两组间调整后的平均住院时间,并考虑机构所在地理区域(城市/地区)和婴儿风险因素。次要结局包括校正年龄至2个月时再次入院和急诊就诊的婴儿比例、出院时的喂养方式、母亲出院时的心理社会困扰和育儿自我效能感。
我们纳入了654名母亲和765名婴儿(543名单胎/111例双胎)。意向性分析包括艾伯塔FICare™组的353名婴儿/308名母亲和标准护理组的365名婴儿/306名母亲。两组间婴儿住院时间的未调整差异(1.96天)无统计学意义。在考虑机构所在地理区域和婴儿风险因素后,艾伯塔FICare™组的婴儿住院时间比标准护理组短2.55天(95%CI,-4.44至-0.66),P = 0.02。两组间次要结局无显著差异。
艾伯塔FICare™在降低二级NICU中早产儿的住院时间方面有效,且不会增加再次入院率或急诊就诊率。单个司法管辖区内少量机构以及特定组别的婴儿限制了研究结果的普遍性。
ClinicalTrials.gov标识符NCT02879799,于2016年8月26日进行回顾性注册。