Trial Outcomes & Findings for Prenatal Steroids for Treatment of Congenital Cystic Adenomatoid Malformations (CCAM) (NCT NCT00670956)

NCT ID: NCT00670956

Last Updated: 2015-03-30

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: Delivery, up to approximately 20 weeks post-enrollment
• Results posted on: 2015-03-30

Participant Flow

Only one participant was enrolled to the study before it was terminated; no participants were enrolled to the control arm

Participant milestones

Measure	Active Study Group STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prenatal Steroids for Treatment of Congenital Cystic Adenomatoid Malformations (CCAM)

Baseline characteristics by cohort

Measure	Active Study Group n=1 Participants STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Delivery, up to approximately 20 weeks post-enrollment

Population: Only one participant was enrolled to the study before it was terminated; no participants were enrolled to the control arm

Outcome measures

Measure	Active Study Group n=1 Participants STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart
Incidence of Hydrops Fetalis	0 participants

SECONDARY outcome

Timeframe: Baseline, Delivery (up to approximately 20 weeks post-enrollment)

Population: Study was terminated without enrollment to control arm; therefore, no comparison was made

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days after delivery (up to approximately 24 weeks post-enrollment)

Status of neonate survival 30 days after delivery

Outcome measures

Measure	Active Study Group n=1 Participants STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart
Survival at One-month Between Study and Control Groups.	1 participants

Adverse Events

Active Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hanmin Lee, MD

University of California San Francisco

Phone: 415-476-4086

Email: hanmin.lee@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place