ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    03132428
Previous Study | Return to List | Next Study

Registry Evaluating Premature and Term-Near-Term Neonates With Pulmonary Hypertension Receiving Inhaled Nitric Oxide (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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03132428
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Brief Summary:
This is a multicenter, prospectively defined, observational registry study evaluating the use of inhaled nitric oxide (INOMAX) in 84 Premature (P) neonates (at least 27 weeks but less than 34 weeks of gestational age [GA]) and 84 Term-Near-Term (TNT) neonates (at least 34 weeks to no more than 40 weeks of GA), with Pulmonary Hypertension (PH). The 2 groups will have a similar number of subjects by severity (mild, moderate, and, severe) and evaluated for response to INOMAX during a treatment period of up to 96 hours ± 12 hours and a safety follow-up through 7 days (for a total of up to 11 days) or to hospital discharge, whichever comes first.

Condition or disease Intervention/treatment
Premature and Term-near-term Neonates With Pulmonary Hypertension Drug: Nitric Oxide Gas, for inhalation: Observational Study

Study Type : Observational
Estimated Enrollment : 168 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
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Premature (P) Neonates
84 P neonates (at least 27 weeks but less than 34 weeks of gestational age [GA])
Drug: Nitric Oxide Gas, for inhalation: Observational Study
nitric oxide gas, for inhalation INOMAX provided either via mechanical ventilation or non invasive ventilation
Other Name: INOmax

Term-Near-Term (TNT) Neonates
84 TNT neonates >34 weeks of age
Drug: Nitric Oxide Gas, for inhalation: Observational Study
nitric oxide gas, for inhalation INOMAX provided either via mechanical ventilation or non invasive ventilation
Other Name: INOmax




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.



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.


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 and term-near-term neonates
Criteria

Inclusion Criteria:

  1. Was either a P neonate born at least 27 weeks to less than 34 weeks of 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 subjects 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 subject 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


Contacts
Contact: Roman Bilyk 800-556-3314 clinicaltrials@mnk.com
Contact: Chitra Sekaran 800-556-3314 clinicaltrials@mnk.com

  Show 21 Study Locations
Sponsors and Collaborators
Mallinckrodt

Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT03132428     History of Changes
Other Study ID Numbers: MNK19050056
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes

Additional relevant MeSH terms:
Hypertension
Premature Birth
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Lung Diseases
Respiratory Tract Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents