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| ID | Type | Description | Link |
|---|---|---|---|
| U10HD021364 | U.S. NIH Grant/Contract | View source | |
| U10HD021373 | U.S. NIH Grant/Contract | View source | |
| U10HD021385 | U.S. NIH Grant/Contract | View source | |
| U10HD027851 | U.S. NIH Grant/Contract | View source | |
| U10HD027853 | U.S. NIH Grant/Contract | View source | |
| U10HD027856 | U.S. NIH Grant/Contract | View source | |
| U10HD027871 | U.S. NIH Grant/Contract | View source | |
| U10HD027880 | U.S. NIH Grant/Contract | View source | |
| U10HD027904 | U.S. NIH Grant/Contract | View source | |
| U10HD034216 | U.S. NIH Grant/Contract | View source | |
| U10HD040492 | U.S. NIH Grant/Contract | View source | |
| U10HD040689 | U.S. NIH Grant/Contract | View source | |
| U10HD053089 | U.S. NIH Grant/Contract | View source | |
| U10HD053109 | U.S. NIH Grant/Contract | View source | |
| U10HD053119 | U.S. NIH Grant/Contract | View source | |
| U10HD053124 | U.S. NIH Grant/Contract | View source | |
| UL1RR024139 | U.S. NIH Grant/Contract | View source | |
| UL1RR025744 | U.S. NIH Grant/Contract | View source | |
| M01RR008084 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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).
An estimated 30-50 percent of infants born at or near term who require ventilation for respiratory failure also receive therapy for hypotension and associated clinical instability, such as poor urine output, poor circulation to the tissues, and metabolic acidosis (a pH imbalance in which the body accumulates too much acid). Emerging evidence, although limited, suggests that the underlying cause of hypotension in many of these infants is that their adrenal glands do not produce adequate amounts of cortisol.
This observational study is to determine the current incidence and management of hypotension in infants born at least 34 0/7 weeks gestation who are intubated and mechanically ventilated at less than 72 hours of age. The goal is to define a target population for a potential randomized controlled trial for the treatment of hypotension in such infants.
In this study, 16 NICHD Neonatal Research Network centers are enrolling at least 50 infants each, collecting basic demographic and baseline data on the mother and baby. In those infants treated for hypotension, data is collected on the dose, duration, and type of therapy, age and blood pressure at the time therapy is started, and the indication for the therapy.
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Hypotension in infants | < 72 hours of age until hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Management of hypotension in infants | < 72 hours of age through resolution of hypotension | |
| Short-term outcomes, including: vasopressor/inotrope exposure, death, time to full nipple feedings, duration of ventilation, and length of NICU stay | < 72 hours of age until hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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All newborn infants born at ≥34 0/7 weeks gestational age admitted to NICU Network centers who are intubated and mechanically ventilated within 72 hours of postnatal age
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| Name | Affiliation | Role |
|---|---|---|
| Abbot R Laptook, MD | Brown University, Women & Infants Hospital of Rhode Island | Principal Investigator |
| Michele C Walsh, MD MS | Case Western Reserve University, Rainbow Babies and Children's Hospital | Principal Investigator |
| Ronald N Goldberg, MD | Duke University | Principal Investigator |
| Barbara J Stoll, MD | Emory University | Principal Investigator |
| Brenda B Poindexter, MD MS | Indiana University | Principal Investigator |
| Abhik Das, PhD | RTI International | Principal Investigator |
| Krisa P Van Meurs, MD | Stanford University | Principal Investigator |
| Ivan D Frantz III, MD | Tufts Medical Center | Principal Investigator |
| Kurt Schibler, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Stanford University |
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| Label | URL |
|---|---|
| NICHD Neonatal Research Network | View source |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Waldemar A Carlo, MD |
| University of Alabama at Birmingham |
| Principal Investigator |
| Edward F Bell, MD | University of Iowa | Principal Investigator |
| Kristi L Watterberg, MD | University of New Mexico | Principal Investigator |
| Pablo J Sanchez, MD | University of Texas, Southwestern Medical Center at Dallas | Principal Investigator |
| Kathleen A Kennedy, MD MPH | The University of Texas Health Science Center, Houston | Principal Investigator |
| Roger G Faix, MD | University of Utah | Principal Investigator |
| Seetha Shankaran, MD | Wayne State University | Principal Investigator |
| Richard A Ehrenkranz, MD | Yale University | Principal Investigator |
| Palo Alto |
| California |
| 94304 |
| United States |
| Yale University | New Haven | Connecticut | 06504 | United States |
| Emory University | Atlanta | Georgia | 30303 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| RTI International | Durham | North Carolina | 27705 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cincinnati Children's Medical Center | Cincinnati | Ohio | 45267 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |