Faculty of Biomedicine, Nursing and Nutrition Department, Universidad Europea de Madrid, 28670 Madrid, Spain.
Department of Neonatal Intensive Care, Hospital Universitario 12 de Octubre, (H12O), 28041 Madrid, Spain.
Int J Environ Res Public Health. 2021 Dec 28;19(1):293. doi: 10.3390/ijerph19010293.
This study aims to assess the efficacy of the modified kangaroo care lateral position on the thermal stability of preterm neonates versus conventional kangaroo care prone position.
A non-inferiority randomized parallel clinical trial. Kangaroo care will be performed in a lateral position for the experimental group and in a prone position for the control group preterm. The study will take place at the neonatal intensive care unit (NICU) of a University Hospital. The participants will be extremely premature infants (under 28 weeks of gestational age) along the first five days of life, hemodynamically stable, with mother or father willing to do kangaroo care and give their written consent to participate in the study. The sample size calculated was 35 participants in each group. When the premature infant is hemodynamically stable and one of the parents stays in the NICU, the patient will be randomized into two groups: an experimental group or a control group. The primary outcome is premature infant axillary temperature. Neonatal pain level and intraventricular hemorrhage are secondary outcomes.
There is no scientific evidence on modified kangaroo care lateral position. Furthermore, there is little evidence of increased intraventricular hemorrhage association with the lateral head position necessary in conventional or prone kangaroo care in extremely premature newborns. Kangaroo care is a priority intervention in neonatal units increasing the time of use more and more, making postural changes necessary to optimize comfort and minimize risks with kangaroo care lateral position as an alternative to conventional prone position kangaroo care. Meanwhile, it is essential to ensure that the conventional kangaroo care prone position, which requires the head to lay sideways, is a safe position in terms of preventing intraventricular hemorrhage in the first five days of life of children under 28 weeks of gestational age. Trial registration at clinicaltrials.gov: NCT03990116.
本研究旨在评估改良袋鼠式护理侧卧位对早产儿体温稳定性的疗效，与传统袋鼠式护理俯卧位相比。
这是一项非劣效性随机平行临床试验。实验组早产儿将采用侧卧位进行袋鼠式护理，对照组早产儿则采用俯卧位。该研究将在一家大学医院的新生儿重症监护病房（NICU）进行。研究对象为极早产儿（胎龄<28 周），生命体征稳定，母亲或父亲愿意进行袋鼠式护理，并书面同意参与研究。计算出的样本量为每组 35 名参与者。当早产儿生命体征稳定且父母一方留在 NICU 时，将患儿随机分为两组：实验组或对照组。主要结局指标为早产儿腋温。新生儿疼痛程度和颅内出血为次要结局。
目前尚无关于改良袋鼠式护理侧卧位的科学证据。此外，对于极早产儿，常规或俯卧位袋鼠式护理中必需的头侧卧位与颅内出血增加之间的关联证据较少。袋鼠式护理是新生儿病房的优先干预措施，使用时间越来越长，因此需要改变体位，以优化舒适度并降低袋鼠式护理侧卧位的风险，作为常规俯卧位袋鼠式护理的替代方法。同时，必须确保传统的袋鼠式护理俯卧位（需要头部侧卧）在胎龄<28 周的儿童生命的头 5 天内是安全的，不会导致颅内出血。本试验已在 clinicaltrials.gov 上注册：NCT03990116。
