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NCT00670956 · ClinicalTrials.gov registry record · Phase 1
Prenatal Steroids for Treatment of Congenital Cystic Adenomatoid Malformations (CCAM)
A Phase 1 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT00670956: Clinical Trial Phase 1 study, sponsored by University of California, San Francisco.
NCT00670956 is a Phase 1 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00670956, a Phase 1 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Congenital cystic adenomatoid malformations (CCAMs) are theorized to be growing immature lung tissue. Administration of maternal steroids in the mid-trimester may stop the growth or decrease the size of the CCAM, thus increasing normal lung tissue and improving survival in fetuses with large CCAMs. This is a prospective, blinded, randomized trial comparing administration of a single course of antenatal steroids (Betamethasone) to control (i.e., placebo). The primary outcome variable will be incidence of hydrops. One month postnatal survival and relative size of the CCAM as determined by CCAM volume:head circumference ratio (CVR) between treatment/no treatment groups will be secondary outcome variables. Change in size of CCAM will be serially followed for both groups with individual growth curves being plotted prenatally and these will be compared with pathology weigh and volume to evaluate treatment effect. Other prenatal data collected will include: incidence of polyhydramnios, incidence of premature rupture of membranes, incidence of material complications. We will also compare mode of delivery, postnatal respiratory compromise, need for resection in the first week of life, and occurrence of complications during newborn administration
Interventions
- DRUG Placebo
- DRUG Betamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2008-04 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
Why NCT00670956 stopped before completion
NCT00670956 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00670956 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00670956 about?
NCT00670956 is a clinical study titled "Prenatal Steroids for Treatment of Congenital Cystic Adenomatoid Malformations (CCAM)". Congenital cystic adenomatoid malformations (CCAMs) are theorized to be growing immature lung tissue. Administration of maternal steroids in the mid-trimester may stop the growth or decrease the size of the CCAM, thus increasing normal lung tissue and improving survival in fetuses with large CCAMs. ...
What is the current status of trial NCT00670956?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2008-04. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00670956?
The interventions under investigation include: Placebo (DRUG), Betamethasone (DRUG).
Who is sponsoring clinical trial NCT00670956?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00670956's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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