Purpose

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 participants 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

Eligibility

Eligible Ages
Between 27 Weeks and 40 Weeks
Eligible Genders
All
Accepts Healthy Volunteers
No

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 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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • 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 names:
    • INOmax

Recruiting Locations

Banner Good Samaritan Medical Center
Phoenix, Arizona 85006

More Details

NCT ID
NCT03132428
Status
Recruiting
Sponsor
Mallinckrodt

Study Contact

Anne Marie Viola
800-556-3314
clinicaltrials@mnk.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.