Hypotension in Neonates

Summary

This observational study collects information on the current incidence and management of hypotension in babies born at term or late preterm that are admitted to Neonatal Intensive Care Units (NICUs) within the Neonatal Research Network (NRN). Participants include all newborn infants born at 34 0/7 weeks gestation or greater who are admitted to NICU Network centers and intubated and mechanically ventilated at less than 72 hours of age. The information gathered will provide a framework for the design of a potential randomized controlled trial for the treatment of hypotension in neonates. This observational study is for a time-limited enrollment period of 4-6 months; NRN centers will continue to enroll until at least 50 patients are enrolled per center (for approximately 800-1,000 subjects total).

Conditions

• Infant, Newborn
• Hypotension
• Blood Pressure

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Abbot R Laptook, MD · Brown University, Women & Infants Hospital of Rhode Island

• Michele C Walsh, MD MS · Case Western Reserve University, Rainbow Babies and Children's Hospital

• Ronald N Goldberg, MD · Duke University

• Barbara J Stoll, MD · Emory University

• Brenda B Poindexter, MD MS · Indiana University

• Abhik Das, PhD · RTI International

• Krisa P Van Meurs, MD · Stanford University

• Ivan D Frantz III, MD · Tufts Medical Center

• Kurt Schibler, MD · Children's Hospital Medical Center, Cincinnati

• Waldemar A Carlo, MD · University of Alabama at Birmingham

• Edward F Bell, MD · University of Iowa

• Kristi L Watterberg, MD · University of New Mexico

• Pablo J Sanchez, MD · University of Texas, Southwestern Medical Center at Dallas

• Kathleen A Kennedy, MD MPH · The University of Texas Health Science Center, Houston

• Roger G Faix, MD · University of Utah

• Seetha Shankaran, MD · Wayne State University

• Richard A Ehrenkranz, MD · Yale University

Eligibility

Max Age

72 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-04-30

Primary Completion

2009-12-31

Completion

2009-12-31

Countries

• United States

Study Locations