Phase 2 Trial of Recombinant Human Prolactin for Lactation Insufficiency

描述（由申请人提供）： 该提案的广泛目标是确定rhPRL治疗早产儿母亲泌乳不足的安全性和有效性。 母乳是婴儿的首选营养品，其基础是对婴儿和母亲的营养、医疗和心理优势。 在早产儿中，母乳提供了比配方奶粉更好的优势，包括更好的消化和营养吸收，更快的喂养进展，降低感染率和感染严重程度，改善视觉功能和神经发育以及降低坏死性小肠结肠炎的发生率。 早产儿的母亲不得不用泵来维持他们的乳汁供应，而婴儿太小或太弱而无法母乳喂养。 到抽奶的第四周，多达50%的母亲的乳汁供应减少，泌乳不足。 早产儿母亲的泌乳不足患病率估计为66 000。 有证据表明，泌乳不足与低催乳素水平有关，增加催乳素可增加乳汁量。 不幸的是，在美国只有一种药物可用于治疗泌乳不足;然而，它没有FDA批准，并且它具有副作用，包括限制其使用的衰弱性抑郁症。 在本提案中，将在为早产儿吸奶以维持乳汁供应而出现泌乳不足的母亲中检查r-hPRL的安全性和有效性。 R-hPRL将给药7天，每日一次或两次。 在治疗期间和研究完成后1周，将比较每日一次r-hPRL、每日两次r-hPRL和安慰剂治疗受试者的催乳素水平和乳汁量。 还将比较r-hPRL和安慰剂治疗组的乳汁组成。 将记录治疗的可接受性和对母亲和婴儿的副作用。 最后，将在1年随访期间评估母乳喂养率和婴儿生长情况。 这项2期研究将是第一个检查r-hPRL用于泌乳诱导的研究，预计将为r-hPRL作为泌乳不足治疗的开发提供关键背景。 因此，这些研究可能提供导致FDA批准的第一种治疗泌乳不足的数据。 此外，这些研究可能进一步确定泌乳素在泌乳中的生理作用。

ADESCRIPTION (provided by applicant): The broad goal of this proposal is to determine the safety and efficacy of rhPRL for lactation insufficiency in mothers of premature infants. Breast milk is the nutrition of choice for infants based on the nutritional, medical and psychological advantages for both the infant and the mother. In premature infants, breast milk provides further advantages over formula including better digestion and nutrient absorption, faster progression of feeding, a decreased rate of infection and infection severity, improved visual function and neurodevelopment and a decreased rate of necrotizing enterocolitis. Mothers of premature infants have to pump to maintain their milk supply while infants are too small or weak to suckle. The milk supply diminishes and lactation insufficiency develops in up to 50% of mothers by the fourth week of pumping. The prevalence of lactation insufficiency in mothers of premature infants is estimated to be 66,000. There is evidence that lactation insufficiency is related to low prolactin levels and that increasing prolactin increases milk volume. Unfortunately, there is only one medication available for treatment of lactation insufficiency in the United States; however, it is not FDA approved and it has side effects including debilitating depression that limit its use. In this proposal, the safety and efficacy of r-hPRL will be examined in mothers who develop lactation insufficiency while pumping to maintain their milk supply for a premature infant. R-hPRL will be administered for 7 days, either once or twice daily. Prolactin levels and milk volume will be compared in the daily r-hPRL, twice daily r-hPRL and placebo treated subjects during treatment and 1 week after study completion. Milk composition will also be compared in r-hPRL and placebo treated groups. Acceptability of the treatment and side effects for both mother and infant will be documented. Finally, breast-feeding rates and infant growth will be assessed during a 1 year follow-up. This Phase 2 study will be the first to examine the use of r-hPRL for lactation induction and is expected to provide the critical backdrop for the development of r-hPRL as a treatment for lactation insufficiency. The studies may thus provide data that lead to the first FDA approved treatment for lactation insufficiency. In addition, these studies may further define the physiological role of prolactin in lactation.