NCT00443859

Brief Summary

Babies who are suspected of having persistent pulmonary hypertension (PPHN) will be included in this study. PPHN is a condition in which the blood is restricted from flowing to the lungs in a normal way making it hard for babies to breath and placing strain on the heart. This study will observe whether certain hormones that measure stress (N-terminal pro-brain natriuretic peptide) can help determine how well a baby will do when they have PPHN.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

2 active sites

Status
terminated

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

February 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

July 11, 2016

Status Verified

May 1, 2009

Enrollment Period

1.6 years

First QC Date

March 2, 2007

Last Update Submit

July 7, 2016

Conditions

Persistent Pulmonary Hypertension of Newborn

Keywords

Persistent Pulmonary HypertensionN-terminal pro brain natriuretic peptide

Study Arms (1)

PPHN

Infants with persistent pulmonary hypertension (PPHN)

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All infants who are admitted to the NICU with a diagnoses of PPHN.

You may qualify if:

  • \>/= 34 weeks gestation at birth
  • clinical diagnosis of PPHN

You may not qualify if:

  • newborns with evidence of structural heart disease, congenital anomalies and prior use of inhaled nitric oxide.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Christiana Hospital

Newark, Delaware, 19718, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Persistent Fetal Circulation Syndrome

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Euming Chong, MD

    Christiana Hospital / Thomas Jefferson University Hospital

    PRINCIPAL INVESTIGATOR

  • Constance Andrejko, DO

    Christiana Hospital / Thomas Jefferson University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2007

First Posted

March 6, 2007

Study Start

February 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

July 11, 2016

Record last verified: 2009-05

Locations

US(2)