CI

At a glance

ClinicalIndex Comparison Record
Phase 2Terminated· 7 enrolled
Drug / intervention
Aerosolized Normal Saline +1 moredrug
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/NCT01467076
NCT01467076Phase 2Terminated
Terminated
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Pilot Randomized Clinical Trial of Inhaled PGE1 in Neonates With Sub-Optimal Response to Inhaled Nitric Oxide

NICHD Neonatal Research Network·interventional·Posted Nov 8, 2011·Updated Apr 24, 2019

In Brief

A Phase 2 clinical trial evaluating Aerosolized Normal Saline and Inhaled PGE1 for Prematurity and 3 related conditions. Terminated early, enrolled 7 participants across 11 sites.

Signals

Trial was terminated early

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrematurity, Respiratory Insufficiency, Pulmonary Hypertension, Respiratory Distress Syndrome, Newborn
CountriesUnited States
CollaboratorsNational Center for Research Resources (NCRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 2TerminatedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 8, 2011
Enrollment StartNov 1, 2011
Primary CompletionMay 1, 2012
Study CompletionJun 1, 2012
TodayJul 1, 2026
Enrollment to primary: 6 monthsPosted 14.6 years ago

Interventions

Aerosolized Normal Salinedrug

Two initial doses of IPGE1 will be tested - 150 and 300 ng/kg/min. Thus, there will be three arms to the study - IPGE1 \[150\], IPGE1 \[300\], and placebo (normal saline). This design will allow comparison of the two doses of IPGE1 with each other and controls; and also allow comparison of any IPGE1 with controls. Placebo will be administered over a maximum duration of 72 hours.

Inhaled PGE1drug

Two initial doses of IPGE1 will be tested - 150 and 300 ng/kg/min. Thus, there will be three arms to the study - IPGE1 \[150\], IPGE1 \[300\], and placebo (normal saline). This design will allow comparison of the two doses of IPGE1 with each other and controls; and also allow comparison of any IPGE1 with controls. In this Pilot RCT, two doses of IPGE1 (300 and 150 ng/kg/min) will be administered over a maximum duration of 72 hours to determine the optimal dose and duration of therapy.