Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network

 描述（由申请人提供）：新墨西哥州大学建议继续努力实现NICHD新生儿研究网络的主要目标，即通过执行严格的多中心临床方案的学术中心网络推进新生儿-围产期医学领域，以调查新生儿治疗和管理策略的安全性和有效性。联合国墨西哥运动已表明它致力于该网络使命的所有方面。PI Kristi Watterberg和Co-PI Robin Ohls在独立和网络内设计和实施临床研究方面拥有丰富的经验，并为NRN提供了重要的智力贡献。Watterberg博士是正在进行的氢化可的松治疗BPD RCT的PI（以及其心脏功能次要研究的副主席），正在进行的氢化可的松治疗足月和晚期早产儿心血管功能不全RCT的共同PI，以及正在进行的肌醇预防早产儿视网膜病变RCT的小组委员会副主席。2013年，她被NHLBI授予R 01（HL 117764），研究“极度早产后6岁时的肾上腺功能和心血管结局”，研究对象是参加SUPPORT学龄随访研究的儿童。她在方案审查小组委员会任职，是一项已批准的早产儿钠和利尿剂研究的共同主要研究者。Ohls博士是指导委员会批准的达贝泊用于早产儿神经保护的RCT的PI，也是另一项批准的RCT，即低温加Epo（HOPE）研究的共同PI。她还担任早产儿输血阈值和NEC剖腹术与引流的RCT的方案小组委员会成员。后续PI Jean Lowe也是一项辅助研究的PI，该研究评估了18 - 22个月的工作记忆与学龄执行功能的相关性，并且是SUPPORT学龄后续研究的两名黄金标准西班牙语考官之一。其他优势包括大量代表性不足的西班牙裔和美洲土著人口（UNM通用数据库患者的56%和24%以及当前资助周期RCT入组的48%和25%，而2013年整体NRN为14%和<1%）;全面的发育护理和随访计划，导致神经发育随访率达到90%（2015年3月NRN总结报告）;全州范围内的外展和运输系统使>85%的极低出生体重婴儿得以出生;与MIND研究网络持续合作，为未来的NRN研究提供独特的成像资源;以及NIH资助的临床和转化科学中心。研究人员的专业知识和经验，以及UNM的设施，项目和患者群体，使UNM成为新生儿研究网络的独特和值得持续的贡献者。

 DESCRIPTION (provided by applicant): The University of New Mexico proposes to continue to work vigorously toward achieving the NICHD Neonatal Research Network primary objective of advancing the field of Neonatal-Perinatal Medicine through a network of academic centers performing rigorous, multi-center clinical protocols to investigate the safety and efficacy of treatment and management strategies for newborn infants. UNM has shown its commitment to all facets of the Network mission. The PI, Kristi Watterberg, and Co-PI, Robin Ohls, have extensive experience in designing and implementing clinical studies, both independently and within the Network, and provide significant intellectual contributions to the NRN. Dr. Watterberg is PI for the ongoing RCT of hydrocortisone to treat BPD (and vice-chair for its secondary study of cardiac function), Co-PI for the ongoing RCT of hydrocortisone for cardiovascular insufficiency in term and late preterm infants, and vice-chair of the subcommittee for the ongoing RCT of inositol to prevent retinopathy of prematurity. In 2013 she was awarded an R01 by NHLBI (HL117764) to study "Adrenal Function and Cardiovascular Outcomes at Age 6 after Extremely Preterm Birth" in children enrolled in the SUPPORT school-age follow up study. She serves on the Protocol Review Subcommittee and is Co-PI for an approved study of sodium and diuretics in preterm infants. Dr. Ohls is PI for a Steering Committee approved RCT of darbepoetin for neuroprotection in preterm infants and is Co-PI for another approved RCT, the Hypothermia plus Epo (HOPE) study. She also serves on protocol subcommittees for the RCTs of transfusion thresholds in preterm infants and laparotomy vs drain for NEC. Jean Lowe, the follow up PI, is also PI of an ancillary study assessing the correlation of working memory at 18 - 22 months with executive function at school age, and is one of two gold standard Spanish examiners for the SUPPORT school-age follow up study. Additional strengths include large under-represented Hispanic and Native American populations (56% and 24% of UNM generic database patients and 48% and 25% of RCT enrollment for the current funding cycle, compared to 14% and <1% for the overall NRN in 2013); a comprehensive Developmental Care and follow-up program resulting in a Neurodevelopmental Follow-up rate of 90% (March 2015 NRN summary report); a statewide outreach and transport system resulting in >85% of VLBW infants being inborn; ongoing collaboration with the MIND Research Network which can provide a unique imaging resource for future NRN studies; and an NIH-funded Clinical and Translational Science Center. The expertise and experience of the investigators, together with the facilities, programs, and patient populations at UNM, make UNM a unique and worthy continuing contributor to the Neonatal Research Network.