Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study

Sponsor

NICHD Neonatal Research Network (Other)

Overall Status

Completed

CT.gov ID

NCT01203423

Collaborator

National Center for Research Resources (NCRR) (NIH)

385

Enrollment

Locations

Duration (Months)

29.6

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Persistent Fetal Circulation Syndrome Persistent Pulmonary Hypertension of Newborn

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.

Study Design

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 :

Oct 1, 1993

Actual Primary Completion Date :

Dec 1, 1994

Actual Study Completion Date :

Dec 1, 1994

Outcome Measures

Primary Outcome Measures

Death [120 days of age]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 7 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94304
2	Yale University	New Haven	Connecticut	United States	06504
3	George Washington University	Washington	District of Columbia	United States	20052
4	University of Miami	Miami	Florida	United States	33136
5	Emory University	Atlanta	Georgia	United States	30303
6	Indiana University	Indianapolis	Indiana	United States	46202
7	Wayne State University	Detroit	Michigan	United States	48201
8	University of New Mexico	Albuquerque	New Mexico	United States	87131
9	Cincinnati Children's Medical Center	Cincinnati	Ohio	United States	45267
10	Case Western Reserve University, Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106
11	Brown University, Women & Infants Hospital of Rhode Island	Providence	Rhode Island	United States	02905
12	University of Tennessee	Memphis	Tennessee	United States	38163
13	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas	United States	75235

Sponsors and Collaborators

NICHD Neonatal Research Network
National Center for Research Resources (NCRR)

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, 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