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润肤疗法对巴基斯坦早产儿临床结局的影响:一项随机对照试验。

Effect of emollient therapy on clinical outcomes in preterm neonates in Pakistan: a randomised controlled trial.

作者信息

Salam Rehana A, Darmstadt Gary L, Bhutta Zulfiqar A

机构信息

Division of Women & Child Health, The Aga Khan University, Karachi, Sindh, Pakistan.

Global Development Division, Bill & Melinda Gates Foundation, Seattle, Washington, USA.

出版信息

Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F210-5. doi: 10.1136/archdischild-2014-307157. Epub 2015 Jan 30.

DOI:10.1136/archdischild-2014-307157
PMID:25637007
Abstract

IMPORTANCE

Newborn oil massage, a traditional community practice, could potentially benefit thermoregulation and skin barrier function, and prevent serious infections, morbidity and mortality in high-risk preterm infants, but has only been evaluated in limited studies in low income settings.

OBJECTIVES

To assess the efficacy of topical coconut oil applications among a cohort of hospital-born preterm infants.

DESIGN

A prospective, individually randomised controlled clinical trial.

SETTING

Nursery and neonatal intensive care unit at Aga Khan University Hospital, Pakistan.

PARTICIPANTS

Of 270 eligible neonates, a consecutive cohort of 258 hospital-born preterm infants (gestational age ≥26 weeks and ≤37 weeks).

INTERVENTION

Twice daily topical application of coconut oil by nurses from birth until discharge and continued thereafter by mothers at home until completion of the 28th day of life.

PRIMARY OUTCOME MEASURES

Incidence of hospital-acquired bloodstream infections.

SECONDARY OUTCOME MEASURES

Weight gain, skin condition and neonatal mortality.

RESULTS

23% of the enrolled neonates developed clinically suspected sepsis while 14% developed blood culture proven infection. The unadjusted hazard for developing hospital-acquired infection in the control group was 4.7 (95% CI 1.8 to 12.4) compared with the intervention group. After adjusting for gestational age, birth weight, duration of intubation and duration of hospitalisation for possible confounding, the hazard for hospital-acquired infection in the control group was 6.0 (95% CI 2.3 to 16) compared with the intervention group. The rate of hospital-acquired infections in the control and intervention groups was 219.1 and 39.5 per 1000 patient-days, respectively. Mean weight gain was 11.3 g/day higher (95% CI 8.1 to 14.6, p<0.0001) and average skin condition was significantly better in the intervention group when compared with controls. There was no significant impact on duration of hospitalisation or neonatal mortality. No adverse effects such as local irritation or local infection were observed among newborns receiving coconut oil applications.

CONCLUSIONS

Topical emollient therapy was effective in maintaining skin integrity and reducing the risk of bloodstream infection in preterm infants in a tertiary hospital setting in Pakistan. The effectiveness of this approach in primary care settings needs to be further explored.

TRIAL REGISTRATION NUMBER

NCT01396642.

摘要

重要性

新生儿油浴按摩是一种传统的社区做法,可能有益于体温调节和皮肤屏障功能,并预防高危早产儿发生严重感染、发病和死亡,但仅在低收入环境下的有限研究中进行过评估。

目的

评估在一组医院出生的早产儿中局部应用椰子油的疗效。

设计

一项前瞻性、个体随机对照临床试验。

地点

巴基斯坦阿迦汗大学医院的新生儿病房和新生儿重症监护室。

参与者

在270名符合条件的新生儿中,连续选取258名医院出生的早产儿(胎龄≥26周且≤37周)。

干预措施

护士从出生至出院每天两次局部涂抹椰子油,出院后母亲在家继续涂抹,直至出生后第28天结束。

主要结局指标

医院获得性血流感染的发生率。

次要结局指标

体重增加、皮肤状况和新生儿死亡率。

结果

23%的入选新生儿出现临床疑似败血症,14%出现血培养证实的感染。与干预组相比,对照组发生医院获得性感染的未调整风险为4.7(95%置信区间1.8至12.4)。在对胎龄、出生体重、插管时间和住院时间进行调整以排除可能的混杂因素后,与干预组相比,对照组发生医院获得性感染的风险为6.0(95%置信区间2.3至16)。对照组和干预组的医院获得性感染率分别为每1000患者日219.1例和39.5例。与对照组相比,干预组的平均体重增加高11.3克/天(95%置信区间8.1至14.6,p<0.0001),平均皮肤状况明显更好。对住院时间或新生儿死亡率没有显著影响。在接受椰子油涂抹的新生儿中未观察到局部刺激或局部感染等不良反应。

结论

在巴基斯坦一家三级医院环境中,局部润肤治疗可有效维持早产儿的皮肤完整性并降低血流感染风险。这种方法在初级保健环境中的有效性需要进一步探索。

试验注册号

NCT01396642。

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