Hypothermia for encephalopathy in low-income and middle-income countries: feasibility of whole-body cooling using a low-cost servo-controlled device.

Hypothermia for encephalopathy in low-income and middle-income countries: feasibility of whole-body cooling using a low-cost servo-controlled device.
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DOI:
10.1136/bmjpo-2017-000245
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发表时间:
2018
影响因子:
2.6
通讯作者:
Thayyil S
Thayyil S
中科院分区:
医学4区
文献类型:
--
作者:
Oliveira V;Kumutha JR;E N;Somanna J;Benkappa N;Bandya P;Chandrasekeran M;Swamy R;Mondkar J;Dewang K;Manerkar S;Sundaram M;Chinathambi K;Bharadwaj S;Bhat V;Madhava V;Nair M;Lally PJ;Montaldo P;Atreja G;Mendoza J;Bassett P;Ramji S;Shankaran S;Thayyil S

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虽然治疗性低温(TH)是高收入国家缺氧缺血性脑病的标准治疗方法,但该疗法在低收入和中等收入国家(LMIC)的安全性和有效性尚不清楚。我们的目的是描述TH的可行性,使用低成本的伺服控制的冷却设备和冷却的婴儿在LMIC的短期结果。我们招募了在印度公立三级新生儿病房住院28个月的中度或重度缺氧缺血性脑病(<6小时)婴儿。我们使用伺服控制装置进行全身冷却(将核心温度设定为33.5°C)72小时,然后进行被动复温。我们收集了出院前新生儿短期结局的数据。82名婴儿被纳入-61名(74%)患有中度脑病,21名(26%)患有重度脑病。平均(SD)低温冷却诱导时间为1.7小时(1.5),有效冷却时间为95%(0.08)。平均(SD)低温诱导时间为1.7小时(1.5小时),冷却期间核心温度为33.4°C(0.2),复温率为0.34°C(0.16°C)/小时,有效冷却时间为95%(8%)。25名(51%)婴儿在分娩时有胃出血,6名(12%)有肺出血,21名(27%)有胎粪。15名(18%)婴儿在出院前死亡。降温期间心率超过120 bpm(P=0.01)和胃出血(P<0.001)与新生儿死亡率相关。低成本的伺服控制冷却装置将核心温度保持在目标范围内。需要进行有说服力的临床试验来确定TH在LMIC中的安全性和有效性。 NCT01760629。
Although therapeutic hypothermia (TH) is the standard of care for hypoxic ischaemic encephalopathy in high-income countries, the safety and efficacy of this therapy in low-income and middle-income countries (LMICs) is unknown. We aimed to describe the feasibility of TH using a low-cost servo-controlled cooling device and the short-term outcomes of the cooled babies in LMIC. We recruited babies with moderate or severe hypoxic ischaemic encephalopathy (aged <6 hours) admitted to public sector tertiary neonatal units in India over a 28-month period. We administered whole-body cooling (set core temperature 33.5°C) using a servo-controlled device for 72 hours, followed by passive rewarming. We collected the data on short-term neonatal outcomes prior to hospital discharge. Eighty-two babies were included—61 (74%) had moderate and 21 (26%) had severe encephalopathy. Mean (SD) hypothermia cooling induction time was 1.7 hour (1.5) and the effective cooling time 95% (0.08). The mean (SD) hypothermia induction time was 1.7 hour (1.5 hour), core temperature during cooling was 33.4°C (0.2), rewarming rate was 0.34°C (0.16°C) per hour and the effective cooling time was 95% (8%). Twenty-five (51%) babies had gastric bleeds, 6 (12%) had pulmonary bleeds and 21 (27%) had meconium on delivery. Fifteen (18%) babies died before discharge from hospital. Heart rate more than 120 bpm during cooling (P=0.01) and gastric bleeds (P<0.001) were associated with neonatal mortality. The low-cost servo-controlled cooling device maintained the core temperature well within the target range. Adequately powered clinical trials are required to establish the safety and efficacy of TH in LMICs. NCT01760629.