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
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5721 S. Maryland Avenue
Chicago, Illinois 60637
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
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700 Childrens Drive
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Durham, North Carolina 27710
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2500 N State St
Jackson, Mississippi 39216
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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
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South 34th Street
Philadelphia, Pennsylvania 19104
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4502 Medical Drive
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4202 E Fowler Ave
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(813) 974-2011
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1801 Inwood Rd
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Grand Rapids, Michigan 49503
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800 Rose Street
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Oklahoma City, Oklahoma 73104
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Pittsburgh, Pennsylvania 15213
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101 Dudley St
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Saint Louis, Missouri 63110
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