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Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01203423
First received: September 15, 2010
Last updated: January 9, 2011
Last verified: September 2010
  Purpose

This study was an observational study to estimate the prevalence of Persistent pulmonary hypertension of the newborn (PPHN) among term or near-term infants with severe respiratory disease.


Condition
Infant, Newborn
Infant, Low Birth Weight
Infant, Small for Gestational Age
Infant, Premature
Persistent Fetal Circulation Syndrome
Persistent Pulmonary Hypertension of Newborn

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Death [ Time Frame: 120 days of age ] [ Designated as safety issue: No ]

Enrollment: 385
Study Start Date: October 1993
Study Completion Date: December 1994
Primary Completion Date: December 1994 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The infants were screened within the first 24 hours and were followed until enrollment criteria were met or until they reached 7 days of age, whichever occurred first.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203423

Locations
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
Sponsors and Collaborators
Investigators
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 Cincinnati Children's Medical Center
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
  More Information

Additional Information:
Publications:
Responsible Party: Michele C. Walsh/ Lead Principal Investigator, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01203423     History of Changes
Other Study ID Numbers: NICHD-NRN-0009, U10HD027881, U10HD021373, U10HD027851, U10HD027853, U10HD021397, U01HD019897, U10HD021415, U10HD027856, U10HD021364, U10HD027880, U10HD027904, U10HD027871, U10HD021385, M01RR000997, M01RR008084, M01RR000750, M01RR000070, M01RR006022
Study First Received: September 15, 2010
Last Updated: January 9, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Prematurity
Persistent Pulmonary Hypertension of Newborn (PPHN)

Additional relevant MeSH terms:
Birth Weight
Hypertension
Hypertension, Pulmonary
Persistent Fetal Circulation Syndrome
Body Weight
Cardiovascular Diseases
Infant, Newborn, Diseases
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014