Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW 2065, Australia; Physiotherapy Department, Royal North Shore Hospital, St Leonards, NSW 2065, Australia; John Walsh Centre for Rehabilitation Research, Northern Sydney Local Health District, St Leonards, Sydney, NSW, Australia.
Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW 2065, Australia; Department of Neonatology, Royal North Shore Hospital, Sydney, Australia..
Early Hum Dev. 2024 Nov;198:106111. doi: 10.1016/j.earlhumdev.2024.106111. Epub 2024 Sep 2.
It is unknown whether ultra-early physiotherapy commenced during neonatal intensive care unit admission is of value for optimising developmental outcomes in preterm/term infants at high-risk of cerebral palsy or motor-delay.
To determine whether ultra-early parent-administered physiotherapy to preterm/term high- risk infants commenced at earliest from 34-weeks post menstrual age, improves motor outcomes at 16-weeks corrected age (CA) compared to usual care.
Single-blind randomised controlled pilot study with 30 infant participants. The primary outcome was the Alberta Infant Motor Scale (AIMS) total score at 16-weeks CA. Secondary outcomes included (i) parent Depression Anxiety and Stress Score and Parent Perceptions Survey at 16-weeks CA; and (ii) Bayley Scales of Infant Development at 12-months CA.
There were no clinically worthwhile effects at 16-weeks CA on the AIMS (mean between-group difference, 95% CI: -0.2, -2.4 to 2.0) or most secondary outcomes. However, the parents' "perception of treatment effectiveness" and "perception of change" favoured the experimental group.
In this pilot trial, there was no clinically worthwhile effect of ultra-early parent-administered physiotherapy over usual care on the AIMS. However, the intervention was feasible for infants, acceptable to parents and parents perceived a benefit of treatment. Whilst this trial did not demonstrate treatment effectiveness using the AIMS, these findings should be interpreted cautiously because of the small sample size, the low responsivity of the AIMS to change in motor performance and the heterogeneity of the participants. Therefore, the intervention should not be abandoned on the basis of this trial, but rather further evaluated in a larger trial that addresses some of the learnings from this one.
目前尚不清楚新生儿重症监护病房入院时开始进行超早期物理治疗是否对优化脑瘫或运动发育迟缓高危早产儿/足月婴儿的发育结局有价值。
确定超早期由家长实施的针对高危早产儿/足月婴儿的物理治疗，从校正胎龄（CA）34 周开始，与常规护理相比，是否能改善校正 16 周 CA 时的运动结局。
这是一项单盲随机对照试验，纳入了 30 名婴儿参与者。主要结局指标为校正 16 周 CA 时的 Alberta 婴儿运动量表（AIMS）总分。次要结局指标包括：（i）校正 16 周 CA 时的父母抑郁、焦虑和压力量表以及父母感知调查；（ii）校正 12 月龄 CA 时的贝利婴幼儿发育量表。
在 16 周 CA 时，AIMS （组间平均差异，95%CI：-0.2，-2.4 至 2.0）或大多数次要结局均无临床意义的获益。然而，父母对“治疗效果的感知”和“对变化的感知”更倾向于实验组。
在这项试验中，与常规护理相比，超早期由家长实施的物理治疗对 AIMS 没有显著的临床获益。然而，该干预措施对婴儿是可行的，父母也能接受，并且父母认为治疗有获益。尽管该试验未使用 AIMS 显示出治疗效果，但由于样本量小、AIMS 对运动表现变化的反应性低以及参与者的异质性，这些发现应谨慎解读。因此，不应基于该试验放弃该干预措施，而应在一项更大的试验中进一步评估，该试验应解决从该试验中获得的一些经验教训。
