van der Pal S M, Maguire C M, Bruil J, Le Cessie S, Wit J M, Walther F J, Veen S
Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands.
Child Care Health Dev. 2008 Sep;34(5):619-25. doi: 10.1111/j.1365-2214.2008.00840.x. Epub 2008 Jun 28.
In the context of a growing interest in developmental care (DC) this study explores the effect of the basic elements of DC and the additional effect of the individual approach of the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) on the health-related quality of life (HRQoL) of very preterm infants at 1 year of age. The basic elements of DC in this study were defined as the use of standardized nests and incubator covers whose protective characteristics were hypothesized to have a positive effect on the infant's HRQoL. The individualized approach of the NIDCAP was thought to further increase HRQoL.
Very preterm (<or=32 weeks) born infants in a Dutch Neonatal Intensive Care Unit at two locations were included in two consecutive randomized controlled trials (RCT) comparing controls (standard care) with basic DC (standardized nests and covers) in the first RCT and basic DC with NIDCAP in the second RCT. Parents completed a questionnaire (RCT 1, n=136; RCT 2, n=128) regarding their infant's HRQoL (TNO-AZL Preschool Quality of Life Questionnaire) at 1 year of age, corrected for prematurity. Because of multiple testing a P-value of below 0.01 was chosen to indicate significance.
HRQoL scores ranged from good to optimal for most infants. No significant differences were found between basic DC vs. controls and NIDCAP vs. basic DC on the child's HRQoL as reported by parents at 1 year of age.
These two RCT show that the basic elements of DC and the more individualized NIDCAP do not improve HRQoL of very preterm infants at 1 year of age.
在对发育照护(DC)的兴趣日益增长的背景下,本研究探讨了DC的基本要素以及新生儿个体化发育照护与评估计划(NIDCAP)的个体化方法对1岁极早产儿健康相关生活质量(HRQoL)的影响。本研究中DC的基本要素被定义为使用标准化睡袋和暖箱罩,其保护特性被假定对婴儿的HRQoL有积极影响。NIDCAP的个体化方法被认为会进一步提高HRQoL。
荷兰两个地点的新生儿重症监护病房中出生的极早产儿(≤32周)被纳入两项连续的随机对照试验(RCT),在第一项RCT中,将对照组(标准护理)与基本DC(标准化睡袋和暖箱罩)进行比较,在第二项RCT中,将基本DC与NIDCAP进行比较。父母在婴儿1岁时填写一份关于其HRQoL的问卷(RCT 1,n = 136;RCT 2,n = 128)(TNO-AZL学龄前生活质量问卷),并对早产进行校正。由于进行了多次检验,选择低于0.01的P值来表示显著性。
大多数婴儿的HRQoL评分从良好到最佳。父母报告1岁时孩子的HRQoL,基本DC与对照组之间以及NIDCAP与基本DC之间未发现显著差异。
这两项RCT表明,DC的基本要素和更个体化的NIDCAP并不能改善1岁极早产儿的HRQoL。