Uwamariya Josee, Mazimpaka Christian, May Leana, Nshimyiryo Alphonse, Feldman Henry A, Sayinzoga Felix, Umutesi Sharon, Gadgil Ashok, Rapp Vi H, Nahimana Evrard, Hansen Anne
Partners In Health/Inshuti Mu Buzima (PIH/IMB), KG9 Avenue, No. 46, Nyarutarama Cell, Remera Sector, Kigali, Gasabo, Rwanda.
Children's Hospital of Colorado, 13123 E 16th Ave, Aurora, CO 80045, United States.
EClinicalMedicine. 2021 Apr 16;34:100842. doi: 10.1016/j.eclinm.2021.100842. eCollection 2021 Apr.
Neonatal hypothermia is a common source of morbidity and mortality in low resource settings. We developed the Dream Warmer, a low cost, re-usable non-electric infant warmer to prevent and treat hypothermia.
We conducted a cluster-randomized stepped-wedge trial. The primary aim was to assess the effect on overall euthermia rates of introducing the warmer compared to standard of care in rural Rwandan hospitals. The secondary aims were to assess effects of warmer introduction on mortality, as well as the safety and feasibility of the warmer. Ten district hospitals participated in the study from November 19th 2019 to July 15th 2020. Patients were eligible to use the warmer if they were 1) hypothermic (temp < 36·5 °C) or 2) or at risk of hypothermia (weight < 2·5 kg or estimated post menstrual age < 35 weeks) when Kangaroo Mother Care was not available. An encounter was defined as the data from an individual infant on a single day. Trial of a Non Electric Infant Warmer for Prevention and Treatment of Hypothermia in Rwanda [NCT03890211].
Over the study period, 3179 patients were enrolled across the ten neonatal wards, yielding 12,748 encounters; 464 unique infants used the warmer 892 times, 79% eligible due to hypothermia. Because of limited study nurse resources, the warmer was used in only 18% of eligible encounters. Despite this low rate of warmer use, the rate of euthermia rose from 51% (95% CI 50-52%) of encounters pre-intervention to 67% (66-68%) post-intervention; < 0·0001. Among the encounters in which the warmer was used, only 11% (9-13%) remained hypothermic. While mortality rates pre- and post-intervention did not change, mortality rate among those who used the warmer was significantly lower than among those who did not (0·9% vs 2·8%, = 0·01). Use of the warmer did not affect hyperthermia rates. There were no safety concerns or instances of incorrect warmer use.
Introduction of the warmer increased rates of euthermia with no associated safety concerns.
在资源匮乏地区，新生儿低体温是发病和死亡的常见原因。我们开发了“梦想暖箱”，这是一种低成本、可重复使用的非电动婴儿暖箱，用于预防和治疗低体温。
我们进行了一项整群随机阶梯楔形试验。主要目的是评估在卢旺达农村医院引入该暖箱与标准护理相比，对总体正常体温率的影响。次要目的是评估引入暖箱对死亡率的影响，以及暖箱的安全性和可行性。2019年11月19日至2020年7月15日，十家地区医院参与了该研究。如果患者1）体温过低（体温<36.5°C）或2）在无法进行袋鼠式护理时存在体温过低风险（体重<2.5 kg或估计月经龄<35周），则有资格使用该暖箱。一次诊疗被定义为单个婴儿一天的数据。卢旺达非电动婴儿暖箱预防和治疗低体温的试验[NCT03890211]。
在研究期间，十个新生儿病房共纳入3179例患者，产生了12748次诊疗；464名独特的婴儿使用该暖箱892次，79%因体温过低符合使用条件。由于研究护士资源有限，该暖箱仅在18%符合条件的诊疗中被使用。尽管暖箱使用率较低，但正常体温率从干预前诊疗的51%（95%CI 50 - 52%）升至干预后的67%（66 - 68%）；P<0.0001。在使用暖箱的诊疗中，只有11%（9 - 13%）仍体温过低。虽然干预前后死亡率没有变化，但使用暖箱的患者死亡率显著低于未使用暖箱的患者（0.9%对2.8%，P = 0.01）。使用暖箱未影响体温过高率。没有安全问题或暖箱使用不当的情况。
引入该暖箱提高了正常体温率，且无相关安全问题。
