Summary

at San Francisco, California and other locations
study started
estimated completion:

Description

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.

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

Keywords

Premature and Term-near-term Neonates With Pulmonary Hypertension Hypertension Premature Birth Hypertension, Pulmonary Nitric Oxide Nitric Oxide Gas, for inhalation: Observational Study Premature (P) Neonates Term-Near-Term (TNT) Neonates

Eligibility

You can join if…

  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).

You CAN'T join if...

  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.

Locations

  • UCSF Benioff Children's Hospital accepting new patients
    San Francisco California 94143 United States
  • Lucile Packard Children's Hospital at Stanford University accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mallinckrodt
ID
NCT03132428
Study Type
Observational
Last Updated