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Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension (PaTTerN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03132428
Recruitment Status : Terminated (Positive results at interim analysis)
First Posted : April 27, 2017
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

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.


Condition or disease Intervention/treatment
Pulmonary Hypertension of Newborn Drug: INOmax

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Study Type : Observational
Actual Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : July 27, 2017
Actual Primary Completion Date : February 11, 2020
Actual Study Completion Date : February 11, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
P Neonates
Premature (P) neonates [at least 27 weeks but less than 34 weeks of gestational age]
Drug: 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
Drug: INOmax
Nitric oxide gas for inhalation provided via mechanical ventilation or non invasive ventilation




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of neonates with significant response to Inomax treatment within each age group and severity group [ Time Frame: within 108 hours ]
    The severity of pulmonary hypertension (PH) is classified for each participant Categories: Mild, Moderate, Severe

  2. Time to reach significant response to Inomax treatment within each age group and severity group [ Time Frame: within 108 hours ]
    The median time to INOmax complete response (25% improvement) for neonates with each baseline PH severity classification Categories: Mild, Moderate, Severe

  3. Number of neonates with partial response to INOmax treatment within each age group and severity group [ Time Frame: within 108 hours ]
    Partial response is defined as less than a 25% improvement in OI/SOI during INOmax treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   27 Weeks to 40 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Premature (P) and term-near-term (TNT) neonates
Criteria

Inclusion Criteria:

  1. 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.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132428


Locations
Show Show 30 study locations
Sponsors and Collaborators
Mallinckrodt
Investigators
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Study Director: Clinical Team Leader Mallinckrodt
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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT03132428    
Other Study ID Numbers: MNK19050056
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mallinckrodt:
Premature and term-near-term neonates
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases