CI

At a glance

ClinicalIndex Comparison Record
Phase 2Withdrawn· 0 enrolled
Drug / intervention
Inhaled Prostaglandin E1drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00598429
NCT00598429Phase 2Withdrawn
Withdrawn
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Randomized Clinical Trial of Inhaled PGE1 (IPGE1) in Neonatal Hypoxemic Respiratory Failure. A Protocol for the NICHD Neonatal Research Network

NICHD Neonatal Research Network·interventional·Posted Jan 21, 2008·Updated Mar 22, 2019

In Brief

A Phase 2 clinical trial evaluating Inhaled Prostaglandin E1 for Infant, Newborn and 4 related conditions. Withdrawn before enrollment, across 11 sites.

Signals

Trial was withdrawn before enrollment

Detailed Summary

This pilot study was a randomized, placebo-controlled, clinical trial to test the safety of using the intravenous form of Prostaglandin E1 (PGE1) in an inhaled form for treatment of hypoxemic respiratory failure in term newborns. The study planned to enroll 50 infants diagnosed with hypoxemic respiratory failure at nine NICHD Neonatal Research Network sites, and randomly assign them to receive one dose over a 72-hour period of either high concentration PGE1 (300 ng/kg/min), low concentration PGE1 (150 ng/kg/min), or placebo (normal saline, the diluent for the drug). In addition to determining the safety, optimal dose, and duration of the therapy, this pilot trial planned to evaluate the feasibility of conducting a larger, multi-center randomized, blinded placebo-controlled trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfant, Newborn, Respiratory Insufficiency, Pulmonary Hypertension, Respiratory Distress Syndrome, Newborn, Streptococcal Infections
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 2WithdrawnFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 21, 2008
Enrollment StartMay 1, 2008
Primary CompletionSep 1, 2008
TodayJul 1, 2026
Enrollment to primary: 4 monthsPosted 18.4 years ago

Interventions

Inhaled Prostaglandin E1drug

Delivery of one dose of either high dose PGE1 (300 ng/kg/min), low dose PGE1 (150 ng/kg/min), or placebo (normal saline, the diluent for the drug) via nebulizer over a 72-hour period