Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network

 描述(由申请人提供)：新墨西哥大学提议继续努力实现NICHD新生儿研究网络的主要目标，通过执行严格的多中心临床方案的学术中心网络来推动新生儿-围产期医学领域的发展，以调查新生儿治疗和管理策略的安全性和有效性。联合国监测机制已显示出它对网络任务的所有方面的承诺。Kristi Watterberg和Co-PI Robin Ohls在独立和在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随机对照试验的PI(其心脏功能二次研究的副主任)，联合PI负责正在进行的氢化可的松治疗足月儿和晚期早产儿心血管功能不全的随机对照试验，以及正在进行的肌醇预防早产儿视网膜病变随机对照试验的小组委员会副主席。2013年，她被NHLBI(HL117764)授予R01奖，以研究参与支持学龄跟踪研究的儿童在6岁时的肾上腺功能和极早产后的心血管结局。她是议定书审查小组委员会的成员，也是一项批准的早产儿钠和利尿剂研究的合作者。Ohls博士是指导委员会批准的Darbepoetin用于早产儿神经保护的RCT的PI，并是另一项批准的RCT-低温加EPO(HOPE)研究的共同PI。她还担任早产儿输血阈值随机对照试验和NEC开腹与引流方案小组委员会的成员。让·洛也是一项评估18-22个月工作记忆与学龄期执行功能相关性的辅助研究的PI，也是支持学龄后续研究的两名标准西班牙考官之一。其他优势包括：大量代表不足的拉美裔和美洲原住民(UNM非专利数据库患者的56%和24%，以及本资助周期RCT登记人数的48%和25%，而2013年整个NRN分别为14%和1%)；全面的发展护理和后续计划，神经发育随访率达到90%(2015年3月NRN摘要报告)；全州范围的外联和运输系统导致&GT；85%的VLBW婴儿出生；与Mind Research Network的持续合作，可以为未来的NRN研究提供独特的成像资源；以及由美国国立卫生研究院资助的临床和翻译科学中心。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有价值的持续贡献者。

 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.