Department of Neonatology, Pramukhswami Medical College, Bhaikaka University, Karamsad, Gujarat, 388325, India.
Central Research Services, Bhaikaka University, Karamsad, Gujarat, 388325, India.
Sci Rep. 2023 Mar 16;13(1):4368. doi: 10.1038/s41598-023-29388-0.
The objective of the study was to determine if using the hypothermia-detecting bracelet (named BEMPU) improves the duration of Kangaroo Mother Care (KMC) at home by one hour. This parallel-group randomized controlled trial was conducted at a step-down nursery of a teaching hospital. Neonates between 1000 and 2000 g were randomized to BEMPU and control groups at the time of discharge. BEMPU was applied at the wrist of each newborn in the BEMPU (intervention) group. Parents were advised to keep the BEMPU in place till 4 weeks post-discharge. The BEMPU generates a beep sound as an alarm when a newborn's temperature drops below 36.5 °C. Parents in both groups were trained to provide KMC at home. Parents in the BEMPU group received the "KMC chart" and "BEMPU beep chart," while the control group received the "KMC chart" only. In the "KMC chart," parents entered information about KMC hours on a real-time basis, and in the "BEMPU beep chart," they entered information about alarm beeps from BEMPU on a real-time basis till 4 weeks post-discharge. Independent samples t-test was used to compare mean KMC hours between the two groups. A total of 128 neonates participated in the study (64 in BEMPU and 64 in Control groups). The mean(SD) gestational age for the BEMPU group was 34.04(2.84) weeks vs 34.75(2.70) weeks for the control group. In BEMPU group, mean(SD) daily time spent doing KMC was significantly higher in 1st week [4.78(2.93) vs. 3.22(2.44) h, p = 0.003], in 2nd week [4.52(3.43) vs. 2.84(2.95) h, p = 0.008], in 3rd week [4.23(3.71) vs. 2.30(2.70) h, p = 0.003], in 4th week [3.72(3.30) vs. 1.95(2.65) h, p = 0.003] as compared to control group. BEMPU improved the daily duration of KMC hours at home compared to the control group over four weeks. Clinical Trial Registration: This trial is registered at Clinical Trials Registry India with registration number: CTRI/2018/08/015154 and accessible at http://ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=27600&EncHid=&modid=&compid=%27,%2727600det%27 Registered on 01/08/2018.
研究目的是确定使用低温检测手环（名为 BEMPU）是否能将家庭袋鼠式护理（KMC）的持续时间延长一个小时。这项平行分组随机对照试验在一家教学医院的过渡病房进行。在出院时，将 1000-2000 克的新生儿随机分为 BEMPU 组和对照组。BEMPU 组的每个新生儿手腕上都佩戴 BEMPU。建议家长在出院后 4 周内保持 BEMPU 在位。当新生儿体温降至 36.5°C 以下时，BEMPU 会发出哔哔声作为警报。两组家长均接受在家中进行 KMC 的培训。BEMPU 组的家长收到了“KMC 图表”和“BEMPU 哔哔声图表”，而对照组只收到了“KMC 图表”。在“KMC 图表”中，家长实时记录 KMC 小时数，在“BEMPU 哔哔声图表”中，家长实时记录 BEMPU 发出的警报声，直到出院后 4 周。采用独立样本 t 检验比较两组 KMC 小时数的均值。共有 128 名新生儿参与了这项研究（BEMPU 组 64 名，对照组 64 名）。BEMPU 组的平均（SD）胎龄为 34.04（2.84）周，对照组为 34.75（2.70）周。BEMPU 组在第 1 周[4.78（2.93）vs. 3.22（2.44）h，p=0.003]、第 2 周[4.52（3.43）vs. 2.84（2.95）h，p=0.008]、第 3 周[4.23（3.71）vs. 2.30（2.70）h，p=0.003]、第 4 周[3.72（3.30）vs. 1.95（2.65）h，p=0.003]的每日 KMC 时间明显高于对照组。与对照组相比，BEMPU 在家中 KMC 小时的日常持续时间提高了 4 周。临床试验注册：该试验在印度临床试验注册中心注册，注册号为 CTRI/2018/08/015154，可在 http://ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=27600&EncHid=&modid=&compid=%27,%2727600det%27 获得。于 2018 年 8 月 1 日注册。
