Clinical trialNCT01467076TerminatedPhase 2Interventional

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

SponsorNICHD Neonatal Research NetworkEnrollment7PrematurityPulmonary HypertensionRespiratory Distress Syndrome, NewbornRespiratory Insufficiency

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Abhik Das, PhD
RTI International
Principal Investigator
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Beena Sood, MD
Wayne State University
Principal Investigator
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C. Michael Cotten, MD
Duke University
Principal Investigator
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Jonathan M Klein, MD
University of Iowa
Principal Investigator
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Krisa P Van Meurs, MD
Stanford University
Principal Investigator
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Leif Nelin, MD
Research Institute at Nationwide Children's Hospital
Principal Investigator
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Martin Keszler, MD
Brown University, Women & Infants Hospital of Rhode Island
Principal Investigator
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Namasivayam Ambalavanan, MD
University of Alabama at Birmingham
Principal Investigator
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Pablo J Sanchez, MD
University of Texas, Southwestern Medical Center at Dallas
Principal Investigator
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Robin Ohls, MD
University of New Mexico
Principal Investigator
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Satyan Lakshminrusimha, MD
University of Rochester
Principal Investigator
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Uday Devaskar, MD
University of California, Los Angeles
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

11 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Aerosolized Normal SalineInhaled PGE1

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Nov 2011
Primary completion: 31 May 2012
Completion: 30 Jun 2012
Last update posted: 24 Apr 2019
Registered enrollment: 7
Registry id: NCT01467076

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.