Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study (PPHN)
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| ClinicalTrials.gov Identifier: NCT01203423 |
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Recruitment Status :
Completed
First Posted : September 16, 2010
Last Update Posted : March 22, 2019
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| Condition or disease |
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| Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Persistent Fetal Circulation Syndrome Persistent Pulmonary Hypertension of Newborn |
The optimal approach to the treatment of PPHN remains controversial. In 1978, hyperventilation was advocated for the treatment of PPHN. Newer therapies such as alkali infusion have been introduced without the support of randomized trial. In addition, in 1993, large controlled trials of inhaled nitric oxide were in the planning stages. There is a lack of knowledge about how these diverse management styles impact patient outcome.
Given the large number of treatments used in neonates with PPHN, we wished to document treatment of PPHN and outcomes of those treatments. Therefore, we performed a prospective, observational study to document prevalence of PPHN, the treatments and outcomes in a large population of infants treated at the 12 centers of the National Institute of Child Health and Human Development (NICHD) Neonatal Research Network. Further, we sought to compare treatment with hyperventilation to treatment with alkali infusion.
| Study Type : | Observational |
| Actual Enrollment : | 385 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study |
| Study Start Date : | October 1993 |
| Actual Primary Completion Date : | December 1994 |
| Actual Study Completion Date : | December 1994 |
- Death [ Time Frame: 120 days of age ]
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| Ages Eligible for Study: | up to 7 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- >= 34 weeks gestational age
- On mechanical ventilation and/or fraction of inspired oxygen >0.50; and
- Had documented pulmonary artery hypertension as defined by either two-dimensional echocardiographic evidence of elevated pulmonary pressure (judged by right to left or bidirectional shunt), or a preductal to postductal oxygen gradient >20 mm Hg
Exclusion Criteria:
- >7 days of age
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203423
| United States, California | |
| Stanford University | |
| Palo Alto, California, United States, 94304 | |
| United States, Connecticut | |
| Yale University | |
| New Haven, Connecticut, United States, 06504 | |
| United States, District of Columbia | |
| George Washington University | |
| Washington, District of Columbia, United States, 20052 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30303 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, Ohio | |
| Cincinnati Children's Medical Center | |
| Cincinnati, Ohio, United States, 45267 | |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Rhode Island | |
| Brown University, Women & Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Tennessee | |
| University of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75235 | |
| Study Director: | Michele C. Walsh, MD MS | Case Western Reserve University | |
| Principal Investigator: | Lu-Ann Papile, MD | University of New Mexico | |
| Principal Investigator: | Jon E. Tyson, MD MPH | University of Texas | |
| Principal Investigator: | Barbara J. Stoll, MD | Emory University | |
| Principal Investigator: | Edward F. Donovan, MD | Children's Hospital Medical Center, Cincinnati | |
| Principal Investigator: | Charles R. Bauer, MD | University of Miami | |
| Principal Investigator: | Raymond Bain, PhD | George Washington University | |
| Principal Investigator: | Sheldon B. Korones, MD | University of Tennessee at Memphis | |
| Principal Investigator: | James A. Lemons, MD | Indiana University | |
| Principal Investigator: | David K. Stevenson, MD | Stanford University | |
| Principal Investigator: | William Oh, MD | Brown University, Womens and Infants Hospital | |
| Principal Investigator: | Richard A. Ehrenkranz, MD | Yale University | |
| Principal Investigator: | Seetha Shankaran, MD | Wayne University |
Publications of Results:
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NICHD Neonatal Research Network Extremely Low Birth Weight (ELBW) Prematurity Persistent Pulmonary Hypertension of Newborn (PPHN) |
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Hypertension, Pulmonary Persistent Fetal Circulation Syndrome Hypertension Birth Weight Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Body Weight Infant, Newborn, Diseases |