Autopsy report · NCT01467076

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

“The study was halted due to futility concerns based on the unmet benchmarks as specified in the pilot study protocol.”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 7 months before it stopped.
• 7 participants enrolled.
• Results were posted on the registry 4 years 6 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

NICHD Neonatal Research Network

Sponsor type

University, hospital or other

Conditions

Prematurity; Respiratory Insufficiency; Pulmonary Hypertension; Respiratory Distress Syndrome, Newborn

Interventions

Aerosolized Normal Saline; Inhaled PGE1

Participants

7

Sites

11

Countries

United States

Trials that died the same way

• Tissue Adhesive vs. Sterile Strips After Cesarean Delivery
  “Based on results of an interim analysis, the study was halted for futility” (75% match in meaning)
• Stroke With Transfusions Changing to Hydroxyurea
  “The study has been stopped due to safety and futility concerns.” (74% match in meaning)
• Comparison Between Radiofrequency and Balloon Compression in the Treatment of Idiopathic Trigeminal Neuralgia
  “Study halted due to futility” (71% match in meaning)
• Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)
  “The study stopped due to futility” (70% match in meaning)
• Trial Investigating the Efficacy and Safety of SCH 900435 (Org 25935) in Relapse Prevention in Participants With Alcohol Dependence (P05718)
  “Based on the outcome of a planned interim analysis, the study was stopped early due to futility.” (70% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.