Pulmonary Hypertension of NewbornPaTTerNNCT03132428
Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension
An observational study of Pulmonary Hypertension of Newborn, run by Mallinckrodt at 30 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 27 to 40 weeks
- Conditions the study is for
- Pulmonary Hypertension of Newborn
- What is being tested?
- INOmax
- How many people
- 140 participants
- Where
- 30 sitesUnited States
- Study dates
- 27 Jul 2017to 11 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 40 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Premature (P) and term-near-term (TNT) neonates
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
University of Chicago Comer Children's Hospital
Chicago, Illinois, 60637
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
University Hospitals Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
Duke University
Durham, North Carolina, 27710
University of Iowa Stead Family Children's Hospital
Iowa City, Iowa, 52242
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Children's Mercy Hospital
Kansas City, Missouri, 64108
University of Kentucky Chandler
Lexington, Kentucky, 40536
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202
Loma Linda University Health Care
Loma Linda, California, 92354
Miller Children's and Women's Hospital - Long Beach
Long Beach, California, 90801
Norton Children's Hospital
Louisville, Kentucky, 40202
University of Minnesota Amplatz Children's Hospital
Minneapolis, Minnesota, 55454
Yale New Haven Children's Hospital
New Haven, Connecticut, 06520
Children's Hospital of New Jersey at Newark Beth Israel Medical Center
Newark, New Jersey, 07112
The Children's Hospital at OU Medical Center
Oklahoma City, Oklahoma, 73104
Children's Hospital of Orange County
Orange, California, 92868
Florida Hospital for Children
Orlando, Florida, 32803
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
Virginia Commonwealth University
Richmond, Virginia, 23298
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, 92123
UCSF Benioff Children's Hospital
San Francisco, California, 94143
Saint Louis Children's Hospital
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33620
About this study
Official title: 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
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.
- Conditions
- Pulmonary Hypertension of Newborn
- Being tested
- INOmax
- Keywords
- Premature and term-near-term neonates
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INOmaxDrug
Nitric oxide gas for inhalation provided via mechanical ventilation or non invasive ventilation
| Study group | Role | What they receive |
|---|---|---|
| P Neonates | Premature (P) neonates [at least 27 weeks but less than 34 weeks of gestational age] Receives: Drug: INOmax | |
| TNT Neonates | Term-Near-Term (TNT) neonates at least 34 weeks of gestational age Receives: Drug: INOmax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 108 hours
Secondary outcomes (3)
Number of neonates with significant response to Inomax treatment within each age group and severity group
The severity of pulmonary hypertension (PH) is classified for each participant Categories: Mild, Moderate, Severe
Measured: within 108 hours
Time to reach significant response to Inomax treatment within each age group and severity group
The median time to INOmax complete response (25% improvement) for neonates with each baseline PH severity classification Categories: Mild, Moderate, Severe
Measured: within 108 hours
Number of neonates with partial response to INOmax treatment within each age group and severity group
Partial response is defined as less than a 25% improvement in OI/SOI during INOmax treatment
Measured: within 108 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start27 Jul 2017
- Primary completion11 Feb 2020
- Study completion11 Feb 2020
Why it stopped: Positive results at interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Hypertension of NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Team Leader, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132428
- Sponsor's protocol ID
- MNK19050056
- Acronym
- PaTTerN
- Status last verified
- Jun 2020
- First submitted
- 25 Apr 2017
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34711938
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03132428
- Acronym / sponsor ID
- PaTTerN / MNK19050056
- Conditions
- Pulmonary Hypertension of Newborn
- Keywords
- Premature and term-near-term neonates
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Positive results at interim analysis
- Enrolment
- 140 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P Neonates | – | Drug: INOmaxPremature (P) neonates [at least 27 weeks but less than 34 weeks of gestational age] |
| TNT Neonates | – | Drug: INOmaxTerm-Near-Term (TNT) neonates at least 34 weeks of gestational age |
Who may qualify
- Ages
- 27 to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature (P) and term-near-term (TNT) neonates
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INOmaxNitric oxide gas for inhalation provided via mechanical ventilation or non invasive ventilation | Drug | P Neonates, TNT Neonates |
Primary outcome
Number of neonates with significant response to INOmax treatment within each age group
Time frame: within 108 hours
Significant response is defined as at least a 25% improvement from baseline in oxygenation index or surrogate oxygenation index (OI/SOI) during INOMAX treatment
3 secondary outcomes
Number of neonates with significant response to Inomax treatment within each age group and severity group
Time frame: within 108 hours
Time to reach significant response to Inomax treatment within each age group and severity group
Time frame: within 108 hours
Number of neonates with partial response to INOmax treatment within each age group and severity group
Time frame: within 108 hours
Results and safety
The study was stopped early (reason given: Positive results at interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Derived from this study: PubMed 34711938Nelin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Team Leader study director
Mallinckrodt
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension of Newborn, run by Mallinckrodt at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Positive results at interim analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of neonates with significant response to INOmax treatment within each age group (time frame: within 108 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03132428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.