Randomized Trial of Early Developmental Intervention on Outcomes in Children after Birth Asphyxia in Developing Countries
Randomized Trial of Early Developmental Intervention on Outcomes in Children after Birth Asphyxia in Developing Countries
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DOI：
10.1016/j.jpeds.2012.09.052
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发表时间：
2013-04-01
影响因子：
5.1
通讯作者：
Wright, Linda L.
中科院分区：
文献类型：
--
作者：
Carlo, Waldemar A.;Goudar, Shivaprasad S.;Wright, Linda L.
目的探讨早期发育干预(EDI)是否能改善复苏后儿童的发育能力。研究设计：对出生时接受袋式和面罩呼吸作为复苏一部分的对刺激无反应的婴儿和出生在印度、巴基斯坦和赞比亚农村社区的不需要任何复苏的婴儿进行平行分组随机对照试验。干预措施婴儿从出生后第一个月开始，每隔一周接受一次父母实施的EDI，并由父母培训师进行家访，为期三年。干预组和对照组的父母在家访期间都按相同的时间表接受了健康和安全咨询。结果治疗组婴儿发育指数(102.6+/-9.8)高于对照组(98.0+/-14.6，单侧P=0.0202)，而未复苏组(100.1+/-10.7vs97.7+/-10.4，P=.1392)差异无统计学意义。无论是复苏组(P=.0430)还是未复苏组(P=.0164)，EDI组儿童的精神运动发育指数均较高(P=.0164)。结论在出生时复苏的儿童中，由父母提供的家庭EDI试验提供了治疗对认知和精神运动结果有好处的证据。未复苏和复苏婴儿的MDI和精神运动发育指数评分均在正常范围内，与早期干预无关。(《儿科杂志》2013；162：705-12)。
Objective To determine if early developmental intervention (EDI) improves developmental abilities in resuscitated children.Study design This was a parallel group, randomized controlled trial of infants unresponsive to stimulation who received bag and mask ventilation as part of their resuscitation at birth and infants who did not require any resuscitation born in rural communities in India, Pakistan, and Zambia. Intervention infants received a parent-implemented EDI delivered with home visits by parent trainers every other week for 3 years starting the first month after birth. Parents in both intervention and control groups received health and safety counseling during home visits on the same schedule. The main outcome measure was the Mental Development Index (MDI) of the Bayley Scales of Infant Development, 2nd edition, assessed at 36 months by evaluators unaware of treatment group and resuscitation history.Results MDI was higher in the EDI (102.6 +/- 9.8) compared with the control resuscitated children (98.0 +/- 14.6, 1-sided P = .0202), but there was no difference between groups in the nonresuscitated children (100.1 +/- 10.7 vs 97.7 +/- 10.4, P = .1392). The Psychomotor Development Index was higher in the EDI group for both the resuscitated (P = .0430) and nonresuscitated children (P = .0164).Conclusions This trial of home-based, parent provided EDI in children resuscitated at birth provides evidence of treatment benefits on cognitive and psychomotor outcomes. MDI and Psychomotor Development Index scores of both nonresuscitated and resuscitated infants were within normal range, independent of early intervention. (J Pediatr 2013;162:705-12).