Study Stopped
Positive results at interim analysis
Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension
PaTTerN
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
1 other identifier
observational
140
1 country
30
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2017
Typical duration for all trials
30 active sites
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
First Submitted
Initial submission to the registry
April 25, 2017
CompletedFirst Posted
Study publicly available on registry
April 27, 2017
CompletedStudy Start
First participant enrolled
July 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2020
CompletedJune 18, 2020
June 1, 2020
2.5 years
April 25, 2017
June 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of neonates with significant response to INOmax treatment within each age group
Significant response is defined as at least a 25% improvement from baseline in oxygenation index or surrogate oxygenation index (OI/SOI) during INOMAX treatment
within 108 hours
Secondary Outcomes (3)
Number of neonates with significant response to Inomax treatment within each age group and severity group
within 108 hours
Time to reach significant response to Inomax treatment within each age group and severity group
within 108 hours
Number of neonates with partial response to INOmax treatment within each age group and severity group
within 108 hours
Study Arms (2)
P Neonates
Premature (P) neonates \[at least 27 weeks but less than 34 weeks of gestational age\]
TNT Neonates
Term-Near-Term (TNT) neonates at least 34 weeks of gestational age
Interventions
Nitric oxide gas for inhalation provided via mechanical ventilation or non invasive ventilation
Eligibility Criteria
Premature (P) and term-near-term (TNT) neonates
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mallinckrodtlead
Study Sites (30)
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006, United States
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202, United States
Loma Linda University Health Care
Loma Linda, California, 92354, United States
Miller Children's and Women's Hospital - Long Beach
Long Beach, California, 90801, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, 92123, United States
UCSF Benioff Children's Hospital
San Francisco, California, 94143, United States
Yale New Haven Children's Hospital
New Haven, Connecticut, 06520, United States
Florida Hospital for Children
Orlando, Florida, 32803, United States
University of South Florida
Tampa, Florida, 33620, United States
University of Chicago Comer Children's Hospital
Chicago, Illinois, 60637, United States
University of Iowa Stead Family Children's Hospital
Iowa City, Iowa, 52242, United States
University of Kentucky Chandler
Lexington, Kentucky, 40536, United States
Norton Children's Hospital
Louisville, Kentucky, 40202, United States
University of Minnesota Amplatz Children's Hospital
Minneapolis, Minnesota, 55454, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Saint Louis Children's Hospital
St Louis, Missouri, 63110, United States
Children's Hospital of New Jersey at Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Duke University
Durham, North Carolina, 27710, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
University Hospitals Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
The Children's Hospital at OU Medical Center
Oklahoma City, Oklahoma, 73104, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75235, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Related Publications (1)
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.
PMID: 34711938DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Team Leader
Mallinckrodt
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2017
First Posted
April 27, 2017
Study Start
July 27, 2017
Primary Completion
February 11, 2020
Study Completion
February 11, 2020
Last Updated
June 18, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share