Lancet. 1996 Jul 27;348(9022):229-32.
Preterm babies are at risk of haemorrhagic and ischaemic brain injury. One controlled trial suggested that prophylactic fresh-frozen plasma (FFP) may reduce that risk but did not clarify whether the reduction in periventricular haemorrhage seen on ultrasonography was due to a haemostatic effect or stabilisation of intravascular volume by FFP. We undertook a trial of 776 babies of gestational age at birth less than 32 weeks to look at the short-term and long-term outcome after early prophylactic FFP.
The defined primary trial outcome was survival without identifiable major disability 2 years after birth. The babies were randomly allocated, within 2 h of birth, 20 mL/kg FFP followed by a further 10 mL/kg after 24 h; or the same volumes of a gelatin-based plasma substitute; or maintenance infusion of glucose (control). The three groups were similar at trial entry. Outcome at discharge from hospital after birth (reported elsewhere) was similar in the three groups.
No child was lost to follow-up, and all the surviving children underwent neurological and developmental assessment at the age of 2 years. The proportions dying (21.0%, 24.9%, 20.5%), and the proportions of survivors with a severe disability (11.3%, 11.2%, 14.1%) did not differ significantly between the randomised groups. The survivors had similar mean developmental quotients at age 2 (Griffiths' quotients 94, 97, and 95).
This trial provides no evidence that the routine early use of FFP, or some other form of intravascular volume expansion, affects the risk of death or disability in babies born more than 8 weeks before term.
早产儿有发生出血性和缺血性脑损伤的风险。一项对照试验表明，预防性使用新鲜冰冻血浆（FFP）可能降低这种风险，但未阐明超声检查显示的脑室周围出血减少是由于止血作用还是FFP对血管内容量的稳定作用。我们对776例出生时胎龄小于32周的婴儿进行了一项试验，以观察早期预防性使用FFP后的短期和长期结局。
确定的主要试验结局是出生后2年存活且无明显严重残疾。婴儿在出生后2小时内被随机分配，给予20 mL/kg FFP，24小时后再给予10 mL/kg；或相同体积的明胶基血浆代用品；或维持输注葡萄糖（对照组）。三组在试验入组时相似。出生后出院时的结局（其他地方已报道）在三组中相似。
没有儿童失访，所有存活儿童在2岁时均接受了神经和发育评估。随机分组之间的死亡比例（21.0%、24.9%、20.5%）以及严重残疾存活者的比例（11.3%、11.2%、14.1%）没有显著差异。存活者在2岁时的平均发育商相似（格里菲斯商数分别为94、97和95）。
该试验没有提供证据表明常规早期使用FFP或其他形式的血管内容量扩充会影响早产8周以上出生婴儿的死亡或残疾风险。
