Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension
NCT ID: NCT03132428
Last Updated: 2020-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
140 participants
OBSERVATIONAL
2017-07-27
2020-02-11
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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P Neonates
Premature (P) neonates \[at least 27 weeks but less than 34 weeks of gestational age\]
INOmax
Nitric oxide gas for inhalation provided via mechanical ventilation or non invasive ventilation
TNT Neonates
Term-Near-Term (TNT) neonates at least 34 weeks of gestational age
INOmax
Nitric oxide gas for inhalation provided via mechanical ventilation or non invasive ventilation
Interventions
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INOmax
Nitric oxide gas for inhalation provided via mechanical ventilation or non invasive ventilation
Eligibility Criteria
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Inclusion Criteria
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
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.
27 Weeks
40 Weeks
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Team Leader
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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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
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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References
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Nelin L, Kinsella JP, Courtney SE, Pallotto EK, Tarau E, Potenziano JL. Use of inhaled nitric oxide in preterm vs term/near-term neonates with pulmonary hypertension: results of the PaTTerN registry study. J Perinatol. 2022 Jan;42(1):14-18. doi: 10.1038/s41372-021-01252-x. Epub 2021 Oct 28.
Other Identifiers
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MNK19050056
Identifier Type: -
Identifier Source: org_study_id
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