NCT01203423

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
385

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 1993

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1993

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1994

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1994

Completed
15.8 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

September 15, 2010

Last Update Submit

March 20, 2019

Conditions

Infant, NewbornInfant, Low Birth WeightInfant, Small for Gestational AgeInfant, PrematurePersistent Fetal Circulation SyndromePersistent Pulmonary Hypertension of Newborn

Keywords

NICHD Neonatal Research NetworkExtremely Low Birth Weight (ELBW)PrematurityPersistent Pulmonary Hypertension of Newborn (PPHN)

Outcome Measures

Primary Outcomes (1)

  • Death

    120 days of age

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • \>= 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

You may not qualify if:

  • \>7 days of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Stanford University

Palo Alto, California, 94304, United States

Location

Yale University

New Haven, Connecticut, 06504, United States

Location

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Tennessee

Memphis, Tennessee, 38163, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (1)

  • Walsh-Sukys MC, Tyson JE, Wright LL, Bauer CR, Korones SB, Stevenson DK, Verter J, Stoll BJ, Lemons JA, Papile LA, Shankaran S, Donovan EF, Oh W, Ehrenkranz RA, Fanaroff AA. Persistent pulmonary hypertension of the newborn in the era before nitric oxide: practice variation and outcomes. Pediatrics. 2000 Jan;105(1 Pt 1):14-20. doi: 10.1542/peds.105.1.14.

    PMID: 10617698RESULT

Related Links

MeSH Terms

Conditions

Premature BirthPersistent Fetal Circulation Syndrome

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertension, PulmonaryLung DiseasesRespiratory Tract DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Michele C. Walsh, MD MS

    Case Western Reserve University

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK

Study Record Dates

First Submitted

September 15, 2010

First Posted

September 16, 2010

Study Start

October 1, 1993

Primary Completion

December 1, 1994

Study Completion

December 1, 1994

Last Updated

March 22, 2019

Record last verified: 2019-03

Locations

US(13)