TY - JOUR
T1 - Overview of the neonatal research network
T2 - History, contributions, challenges, and future
AU - Watterberg, Kristi L.
AU - Carlo, Waldemar A.
AU - Brion, Luc P.
AU - Cotten, C. Michael
AU - Higgins, Rosemary D.
N1 - Funding Information:
Supported in part by cooperative agreements from the National Institutes of Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ( U10 HD21373 , UG1 HD21364 , UG1 HD21385 , UG1 HD27851 , UG1 HD27853 , UG1 HD27856 , UG1 HD27880 , UG1 HD27904 , UG1 HD34216 , UG1 HD36790 , UG1 HD40492 , UG1 HD40689 , UG1 HD53089 , UG1 HD53109 , UG1 HD68244 , UG1 HD68270 , UG1 HD68278 , UG1 HD68263 , UG1 HD68284 ; UG1 HD87226 , UG1 HD87229 ) and the National Center for Advancing Translational Sciences ( NCATS ) ( UL1 TR6 , UL1 TR41 , UL1 TR42 , UL1 TR77 , UL1 TR93 , UL1 TR105 , UL1 TR442 , UL1 TR454 , UL1 TR1117 ).
Funding Information:
With its established infrastructure, the NRN has been attractive to other institutes at NIH as well as other agencies and clinical trials networks. Moreover, the NICHD has actively promoted inter-agency collaborations. The National Institute for Drug Abuse (NIDA), National Heart, Lung and Blood Institute (NHLBI), and the National Eye Institute (NEI) have funded portions of NRN studies. 40 , 70 The Best Pharmaceuticals for Children Act (BPCA) funding has been used for studies of neonatal blood pressure and neuromonitoring, 35 , 71 and the CDC has funded several studies of neonatal sepsis. 72 , 73 These co-funders contribute to capitation, follow-up, investigator salary support, and data coordinating center costs, resulting in cost savings from using existing infrastructure. Currently, the NRN is collaborating with other NIH-supported clinical trials groups, including the Idea States Pediatric Clinical Trials Network (ISPCTN) and the NIH Helping to End Addiction Long-term (HEAL) initiative in the development and implementation of their Eat, Sleep, Console trial (NCT04057820) 74 and Opiate Weaning trial ( NCT04214834 ). 75
Publisher Copyright:
© 2022 Elsevier Inc.
PY - 2022
Y1 - 2022
N2 - The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN) has been a leader in neonatal research since 1986. In this chapter we review its history and achievements in (1) continuing observation of populations, treatments, short and longer-term outcomes, and trends over time; (2) “negative studies” (trials with non-significant primary outcomes) and trials stopped for futility or adverse events, which have influenced practice and subsequent trial design; and, (3) landmark trials that have changed neonatal care. Its consistent framework has enabled the NRN to be a pioneer in conducting longer-term, school-age follow-up. Leveraging its established infrastructure, the NRN has also partnered with other NIH institutes, governmental agencies, and industry to more effectively advance neonatal care. As current examples of its evolution with changing times, the Network has instituted a process to open specific network trials to external institutions and is adding a parent and participant component to future endeavors.
AB - The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN) has been a leader in neonatal research since 1986. In this chapter we review its history and achievements in (1) continuing observation of populations, treatments, short and longer-term outcomes, and trends over time; (2) “negative studies” (trials with non-significant primary outcomes) and trials stopped for futility or adverse events, which have influenced practice and subsequent trial design; and, (3) landmark trials that have changed neonatal care. Its consistent framework has enabled the NRN to be a pioneer in conducting longer-term, school-age follow-up. Leveraging its established infrastructure, the NRN has also partnered with other NIH institutes, governmental agencies, and industry to more effectively advance neonatal care. As current examples of its evolution with changing times, the Network has instituted a process to open specific network trials to external institutions and is adding a parent and participant component to future endeavors.
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U2 - 10.1016/j.semperi.2022.151634
DO - 10.1016/j.semperi.2022.151634
M3 - Article
C2 - 35786518
AN - SCOPUS:85133307003
SN - 0146-0005
JO - Seminars in Perinatology
JF - Seminars in Perinatology
M1 - 151634
ER -