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NCT01240057 · ClinicalTrials.gov registry record · Phase 2
Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial for Severe Pulmonary Hypoplasia
A Phase 2 study, sponsored by University Hospital, Gasthuisberg.
- Completed
- Registry status
- Phase 2
- Development phase
- 93
- Enrollment target
NCT01240057: Completed Phase 2 study, sponsored by University Hospital, Gasthuisberg.
NCT01240057 is a Phase 2 study that has completed, run by University Hospital, Gasthuisberg. The registered enrollment target is 93 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01240057, a Phase 2 study, has completed, sponsored by University Hospital, Gasthuisberg.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 93 participants
- Enrollment target
Study Summary
This trial investigates whether prenatal intervention improves survival rate of fetuses with isolated congenital diaphragmatic hernia and severe pulmonary hypoplasia, as compared to expectant management during pregnancy, both followed by standardized postnatal care.
Primary Outcome
The baby can be discharged either alive (and then it qualifies as "surviving at discharge") or dead. Not discharged babies have not reached the primary endpoint.
Interventions
- PROCEDURE fetal endoluminal tracheal occlusion
- OTHER watchful waiting during pregnancy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2011-11 |
| Est. Completion | 2020-12 |
| Phase | Phase 2 |
What the finished NCT01240057 record still lists
NCT01240057 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 2 interventions - of which fetal endoluminal tracheal occlusion is the first listed.
NCT01240057 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01240057 about?
NCT01240057 is a clinical study titled "Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial for Severe Pulmonary Hypoplasia". This trial investigates whether prenatal intervention improves survival rate of fetuses with isolated congenital diaphragmatic hernia and severe pulmonary hypoplasia, as compared to expectant management during pregnancy, both followed by standardized postnatal care.
What is the current status of trial NCT01240057?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2011-11. Estimated completion is 2020-12.
What interventions are being tested in trial NCT01240057?
The interventions under investigation include: fetal endoluminal tracheal occlusion (PROCEDURE), watchful waiting during pregnancy (OTHER).
Who is sponsoring clinical trial NCT01240057?
This trial is sponsored by University Hospital, Gasthuisberg, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01240057's enrollment target sits among peer trials
93 766th of 2000 higher than 1,234 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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