Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Prematurity, Respiratory Insufficiency, Pulmonary Hypertension, Respiratory Distress Syndrome, Newborn

In brief

This is a randomized controlled trial (RCT) on the use of Inhaled prostaglandin E1 (IPGE1) in Neonatal Hypoxemic Respiratory Failure (NHRF). Fifty patients recruited at 10 high volume sites within the NICHD Neonatal Research Network will constitute a pilot sample to evaluate the feasibility and safety of prolonged IPGE1 administration and determination of optimal dose. In this Pilot RCT, two doses of IPGE1 (300 and 150 ng/kg/min) will be administered over a maximum duration of 72 hours and compared with placebo. Once feasibility and safety of IPGE1 administered over 72 hours has been demonstrated in the pilot trial, a full scale randomized controlled trial will be planned.

Key facts

Study ID

NCT01467076

Run by

NICHD Neonatal Research Network

People needed

7

Starts

2011-11-01

Expected to finish

2012-06-01

Last updated by the study team

2019-04-24

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gestational age less than or equal to 34 weeks
• Postnatal age less than or equal to 7 days (168 hours).
• Assisted ventilation for hypoxemic respiratory failure.
• Diagnosis of NHRF including perinatal aspiration syndrome (meconium, blood, or amniotic fluid), suspected/proven pneumonia/sepsis, respiratory distress syndrome, idiopathic persistent pulmonary hypertension of the newborn (PPHN) or suspected pulmonary hypoplasia.
• Receiving INO for at least 1 hour and not >72 hours.
• Oxygenation Index (OI ) ≥ 15 on any 2 arterial blood gases 15 minutes to 12 hours apart while on INO.
• An indwelling arterial line is present

You may not qualify if…

• Any infant in whom a decision has been made not to provide full treatment (e.g. chromosomal anomalies, severe birth asphyxia).
• Known structural congenital heart disease except patent ductus arteriosus and atrial/ventricular level shunts.
• Congenital diaphragmatic hernia.
• Thrombocytopenia unresponsive to platelet transfusion.
• Enrollment in a conflicting and/or Investigational New Drug (IND) clinical trial.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California - Los Angeles — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• University of Iowa — Iowa City, Iowa, United States
• Wayne State University — Detroit, Michigan, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• University of Rochester — Rochester, New York, United States
• Duke University — Durham, North Carolina, United States
• Research Institute at Nationwide Children's Hospital — Columbus, Ohio, United States
• Brown University, Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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