NICHD Cooperative Multicenter Neonatal Research Network

NICHD 多中心新生儿合作研究网络

• 批准号: 7799869
• 负责人: KRISTI L. WATTERBERG
• 金额: $ 23.94万
• 依托单位: UNIVERSITY OF NEW MEXICO
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7799869
• 关键词: Admission activity; Adrenal gland hypofunction; Area; Beds; Blood Pressure; Bronchopulmonary Dysplasia; Cardiac; Cardiovascular Physiology; Cardiovascular system; Caring; Childhood; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Critical Illness; Data; Development; Diagnosis; Dose; Drug Kinetics; Echocardiography; Enrollment; Environmental air flow; Etiology; Exposure to; Frequencies; Functional disorder; Funding; Future; Glucocorticoids; Hispanics; Hour; Hydrocortisone; Hypotension; Incidence; Infant; Intervention; Length of Stay; Liquid substance; Masks; Measures; Medicine; Metabolic acidosis; Multi-Institutional Clinical Trial; Multicenter Neonatal Research Network; National Institute of Child Health and Human Development; Native Americans; Neonatal; New Mexico; Newborn Infant; Nursing Research; Output; Patients; Perfusion; Perinatal; Phase; Placebo Control; Population; Premature Infant; Principal Investigator; Protocols documentation; Randomized; Recording of previous events; Relative (related person); Research; Research Personnel; Research Proposals; Respiratory Failure; Risk; Rural; Safety; Series; Site; Symptoms; Time; Treatment Efficacy; Universities; Urine; Vasoconstrictor Agents; Very Low Birth Weight Infant; Work; base; cohort; design; experience; follow-up; hypothalamic-pituitary-adrenal axis; improved; infant outcome; mortality; outreach program; patient population; persistent pulmonary hypertension; prevent; programs; research study

DESCRIPTION (provided by applicant): The University of New Mexico proposes to join the NICHD Neonatal Research Network in working to achieve its primary objective of advancing the field of Neonatal-Perinatal Medicine through a network of academic centers that perform rigorous, multicenter clinical protocols to investigate the safety and efficacy of treatment and management strategies for newborn infants. The principal investigator, Kristi Watterberg, MD, and the alternate PI, Lu-Ann Papile, MD, have extensive experience in designing and carrying out both observational and interventional clinical studies. Specifically, Dr. Watterberg designed, received NICHD funding for, and directed all phases of a recent multicenter clinical trial of early, low-dose hydrocortisone therapy to prevent bronchopulmonary dysplasia. Now in its follow-up phase, this study generated important information regarding safety and efficacy of this therapy, critical to designing future studies. Dr. Papile was a NRN PI for 10 years and has a long history of both collaborating and acting as PI for clinical research studies, including several NRN studies. Specific strengths of the UNM program include (1) a neonatal division with broad experience in and commitment to clinical research; (2) the only State-supported level III NICU in New Mexico (50 beds, approx. 800 admissions and 175 very low birth weight admissions/year, expanding to a new facility in 2007), with a significant, under-represented Hispanic(48 percent) and Native American(12 percent) population; (3) one of the largest rural perinatal outreach programs in the nation, resulting in the vast majority of premature infants being inborn (87 percent); (4) the UNM General Clinical Research Center Pediatric Scatterbed Program (directed by Dr. Papile), established more than 25 years ago, which currently has 6 research nurses enrolling patients in 25 research protocols; (5) a comprehensive Developmental Care follow-up program comprised of 9 professionals with specific areas of expertise. This program, founded in 1978, begins with an assessment of each patient admitted to the NICU, designing individualized follow-up based on risk. The followup program works closely with the Neonatal Scatterbed Program of the GCRC to achieve follow-up rates consistently above 85 percent for research studies, and 100 percent for Dr. Watterberg's recent trial. Thus, the facilities, programs and patient population at UNM, together with the expertise and experience of the investigators in this application will make UNM a worthy addition to the NICHD Neonatal Research Network.

描述（由申请人提供）：新墨西哥大学提议加入NICHD新生儿研究网络，致力于通过执行严格的，多中心临床方案的学术中心网络来实现其主要目标，以促进新生儿 - 期限医学的领域，以研究新生婴儿的治疗和管理策略的安全性和管理策略。主要研究员Kristi Watterberg，医学博士和MD Lu-Ann Papile的替代Pi，在设计和进行观察和介入的临床研究方面具有丰富的经验。具体而言，沃特伯格博士设计的，为早期低剂量氢化可的松治疗的最新多中心临床试验的所有阶段提供了NICHD资金，以防止支气管肺发育不良。现在，在其后续阶段，这项研究生成了有关该疗法的安全性和功效的重要信息，这对于设计未来的研究至关重要。 Papile博士一直是NRN PI 10年，并且在合作和充当临床研究的PI（包括几项NRN研究）的历史上很长。 UNM计划的具体优势包括（1）具有广泛经验和对临床研究承诺的新生儿分裂； （2）新墨西哥州唯一由州支持的III NICU（50张床，大约800张入院和175个非常低的出生体重入院，每年扩展到2007年的新设施），具有显着的，占代表性不足的西班牙裔（48％）和美国本地人（12％）人口； （3）全国最大的农村围产期外展计划之一，导致绝大多数的早产儿（87％）； （4）25年前建立的UNM通用临床研究中心小儿分散计划（由Papile博士指导），目前有6位研究护士，招募了25种研究方案的患者； （5）由9位具有特定专业领域的专业人员组成的全面发展护理后续计划。该计划成立于1978年，始于对NICU接纳的每个患者的评估，根据风险设计个性化的随访。后续计划与GCRC的新生儿分散计划紧密合作，以达到研究研究的持续超过85％，而沃特伯格博士最近的试验100％。因此，UNM的设施，计划和患者人口以及调查人员的专业知识和经验 该应用程序将使UNM成为NICHD新生儿研究网络的值得添加。