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

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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

Tracking Information
First Submitted Date April 25, 2017
First Posted Date April 27, 2017
Last Update Posted Date June 18, 2020
Actual Study Start Date July 27, 2017
Actual Primary Completion Date February 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 16, 2020)
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
Original Primary Outcome Measures
 (submitted: April 25, 2017)
25% improvement in oxygenation index (OI) or surrogate oxygenation index (SOI) compared to baseline for neonates who transition between modes of ventilation. [ Time Frame: at least 24 hours and up to 96 +/- 12 hours ]
The incidence of subjects with at least a 25% improvement in OI or SOI during the INOMAX treatment period compared to baseline.
Change History
Current Secondary Outcome Measures
 (submitted: June 16, 2020)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: April 25, 2017)
  • Pulmonary Hypertension (PH) severity within each group (P and TNT) [ Time Frame: at least 24 hours and up to 96 +/- 12 hours ]
    25% improvement in OI/SOI will be summarized for each severity group of mild, moderate, and severe within each age group
  • Response to INOMAX [ Time Frame: up to 96 hours ]
    The time-course of response to INOMAX up to 96 hours for each severity and age group.
  • Evaluation of 25% improvement in OI or SOI for baseline factors [ Time Frame: up to 96 hours ]
    Baseline factors: The effect of the following variables will be assessed with univariate and multivariate logistic regressions for response: neonate age group, severity group, disease subtype, weight, race, and gender.
  • Incidence of subjects with partial response [ Time Frame: up to 96 hours ]
    The incidence of subjects with a partial response, defined as less than 25% improvement in OI/SOI, for nonresponders.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension
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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Premature (P) and term-near-term (TNT) neonates
Condition Pulmonary Hypertension of Newborn
Intervention Drug: INOmax
Nitric oxide gas for inhalation provided via mechanical ventilation or non invasive ventilation
Study Groups/Cohorts
  • P Neonates
    Premature (P) neonates [at least 27 weeks but less than 34 weeks of gestational age]
    Intervention: Drug: INOmax
  • TNT Neonates
    Term-Near-Term (TNT) neonates at least 34 weeks of gestational age
    Intervention: Drug: INOmax
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: June 16, 2020)
140
Original Estimated Enrollment
 (submitted: April 25, 2017)
168
Actual Study Completion Date February 11, 2020
Actual Primary Completion Date February 11, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 27 Weeks to 40 Weeks   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03132428
Other Study ID Numbers MNK19050056
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Mallinckrodt
Study Sponsor Mallinckrodt
Collaborators Not Provided
Investigators
Study Director: Clinical Team Leader Mallinckrodt
PRS Account Mallinckrodt
Verification Date June 2020