Registry Evaluating Premature and Term-Near-Term Neonates With Pulmonary Hypertension Receiving Inhaled Nitric Oxide



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Women's Studies
Therapuetic Areas:Cardiology / Vascular Diseases, Reproductive
Healthy:No
Age Range:Any
Updated:1/11/2019
Start Date:July 27, 2017
End Date:April 2022
Contact:Anne Marie Viola
Email:clinicaltrials@mnk.com
Phone:800-556-3314

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Multicenter, Prospectively Defined Observational Registry With Retrospective Data Collection, Evaluating Premature and Term-Near-Term Neonates With Pulmonary Hypertension Receiving Inhaled Nitric Oxide Via Invasive or Noninvasive Ventilation

This is a multicenter, prospectively defined, observational registry study evaluating the use
of inhaled nitric oxide (INOMAX) in 84 Premature (P) neonates (at least 27 weeks but less
than 34 weeks of gestational age [GA]) and 84 Term-Near-Term (TNT) neonates (at least 34
weeks to no more than 40 weeks of GA), with Pulmonary Hypertension (PH). The 2 groups will
have a similar number of participants by severity (mild, moderate, and, severe) and evaluated
for response to INOMAX during a treatment period of up to 96 hours ± 12 hours and a safety
follow-up through 7 days (for a total of up to 11 days) or to hospital discharge, whichever
comes first.


Inclusion Criteria:

1. Was either a P neonate born at least 27 weeks to less than 34 weeks of GA or a TNT
neonate born at least 34 weeks but no more than 40 weeks of GA.

2. Was administered INOMAX therapy after birth to 7 days of age via any route (invasive
or noninvasive ventilation) for a minimum treatment period of at least 24 hours up to
96 ±12 hours. The participants may receive Inomax for a longer period.

3. Had PH, as confirmed by echocardiogram or a differential saturation gradient of at
least 10%.

4. Received INOMAX administration as part of routine clinical practice in a Level III or
higher neonatal intensive care unit in the United States.

5. Has all variables required to calculate OI or SOI (a baseline sample prior to
treatment and 4 samples obtained during treatment).

Exclusion Criteria:

1. Was at risk of imminent death (death expected within 24 hours).

2. Received extracorporeal membrane oxygenation (ECMO).

3. Had a life-threatening abnormality (cranial, cardiac, thoracic), chromosomal
abnormality, congenital diaphragmatic hernia, congenital heart defect (other than
patent ductus arteriosus or small atrial septal defect).

4. Had been resuscitated requiring chest compressions within 6 hours of receiving INOMAX.

5. Had Grade IV bilateral intraventricular hemorrhage or periventricular leukomalacia.

6. Had active uncontrolled bleeding.

7. Had disseminated intravascular coagulopathy.

8. Had active seizures while receiving anticonvulsants.

9. Experienced prolonged asphyxia with evidence of severe acidosis (pH < 7.25).

10. Received concomitant pulmonary vasodilator therapy (eg, prostacyclin or sildenafil)
except when sildenafil was used to wean the participant from INOMAX therapy.
We found this trial at
32
sites
Saint Louis, Missouri 63110
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5721 S. Maryland Avenue
Chicago, Illinois 60637
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Grand Rapids, Michigan 49503
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800 Rose Street
Lexington, Kentucky 40536
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Little Rock, AR
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Loma Linda, California 92350
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Louisville, Kentucky 40202
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New Haven, Connecticut 06511
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Oklahoma City, Oklahoma 73104
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Orlando, Florida 32803
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Phoenix, Arizona 85006
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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101 Dudley St
Providence, Rhode Island 02905
(401) 274-1100
Women and Infants Hospital of Rhode Island Women & Infants Hospital of Rhode Island, a...
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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San Francisco, California 94143
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