Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension

Stopped early

Conditions studied: Pulmonary Hypertension of Newborn

In brief

Pulmonary hypertension is high blood pressure in the arteries to the lungs. It is a serious condition. It causes the blood vessels that carry blood from the heart to the lungs to become hard and narrow. When this happens, the heart has to work harder to pump the blood through. Some babies are born with pulmonary hypertension (PH). Doctors might use INOmax (a gas the baby breathes) to help newborn babies (neonates) with PH. This study will use information from the records of registered babies to see how effective and safe INOmax is for treating premature and other newborn babies for up to 11 days after they are born.

Key facts

Study ID: NCT03132428
Run by: Mallinckrodt
People needed: 140
Starts: 2017-07-27
Expected to finish: 2020-02-11
Last updated by the study team: 2020-06-18

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Was either a P neonate born at least 27 weeks to less than 34 weeks of gestational age (GA) or a TNT neonate born at least 34 weeks but no more than 40 weeks of GA.
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.
Had PH, as confirmed by echocardiogram or a differential saturation gradient of at least 10%.
Received INOmax administration as part of routine clinical practice in a Level III or higher neonatal intensive care unit in the United States.
Has all variables required to calculate OI or SOI (a baseline sample prior to treatment and 4 samples obtained during treatment).

You may not qualify if…

Was at risk of imminent death (death expected within 24 hours).
Received extracorporeal membrane oxygenation (ECMO).
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).
Had been resuscitated requiring chest compressions within 6 hours of receiving INOmax.
Had Grade IV bilateral intraventricular hemorrhage or periventricular leukomalacia.
Had active uncontrolled bleeding.
Had disseminated intravascular coagulopathy.
Had active seizures while receiving anticonvulsants.
Experienced prolonged asphyxia with evidence of severe acidosis (pH < 7.25).
Received concomitant pulmonary vasodilator therapy (eg, prostacyclin or sildenafil) except when sildenafil was used to wean the participant from INOmax therapy.

Where it is running

Banner Good Samaritan Medical Center — Phoenix, Arizona, United States
Arkansas Children's Hospital Research Institute — Little Rock, Arkansas, United States
Loma Linda University Health Care — Loma Linda, California, United States
Miller Children's and Women's Hospital - Long Beach — Long Beach, California, United States
Children's Hospital of Orange County — Orange, California, United States
Sharp Mary Birch Hospital for Women and Newborns — San Diego, California, United States
UCSF Benioff Children's Hospital — San Francisco, California, United States
Yale New Haven Children's Hospital — New Haven, Connecticut, United States
Florida Hospital for Children — Orlando, Florida, United States
University of South Florida — Tampa, Florida, United States
University of Chicago Comer Children's Hospital — Chicago, Illinois, United States
University of Iowa Stead Family Children's Hospital — Iowa City, Iowa, United States
University of Kentucky Chandler — Lexington, Kentucky, United States
Norton Children's Hospital — Louisville, Kentucky, United States
University of Minnesota Amplatz Children's Hospital — Minneapolis, Minnesota, United States
University of Mississippi Medical Center — Jackson, Mississippi, United States
Children's Mercy Hospital — Kansas City, Missouri, United States
Saint Louis Children's Hospital — St Louis, Missouri, United States
Children's Hospital of New Jersey at Newark Beth Israel Medical Center — Newark, New Jersey, United States
Duke University — Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
University Hospitals Rainbow Babies & Children's Hospital — Cleveland, Ohio, United States
Nationwide Children's Hospital — Columbus, Ohio, United States
The Children's Hospital at OU Medical Center — Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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