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Trial record 98 of 272 for:    Betamethasone

Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants

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ClinicalTrials.gov Identifier: NCT00669383
Recruitment Status : Completed
First Posted : April 30, 2008
Results First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Collaborator:
American Lung Association
Information provided by (Responsible Party):
Cynthia McEvoy, Oregon Health and Science University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Respiratory Compliance
Functional Residual Capacity
Pulmonary Function Testing
Interventions Drug: betamethasone
Drug: placebo
Enrollment 85
Recruitment Details This randomized trial was conducted at Oregon Health and Science University in Portland, OR and at Sacred Heart Hospital in Pensacola, FL. Subjects were recruited from June 2001 to May 2007.
Pre-assignment Details Women who showed no further signs of preterm delivery after consent were not randomized.
Arm/Group Title A (Betamethasone) B (Placebo)
Hide Arm/Group Description Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses Placebo dose IM q 24 hours x 2 doses
Period Title: Overall Study
Started 44 41
Completed 44 41
Not Completed 0 0
Arm/Group Title A (Betamethasone) B (Placebo) Total
Hide Arm/Group Description

Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses

betamethasone: 12 mg IM q 24 hours x 2 doses

Placebo dose IM q 24 hours x 2 doses

placebo: Placebo IM q 24 hours x 2 doses

Total of all reporting groups
Overall Number of Baseline Participants 44 41 85
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 41 participants 85 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
44
 100.0%
41
 100.0%
85
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 41 participants 85 participants
26.9  (7.5) 28.6  (6.4) 27.7  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 41 participants 85 participants
Female
44
 100.0%
41
 100.0%
85
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants 41 participants 85 participants
44 41 85
1.Primary Outcome
Title Measurements of Functional Residual Capacity in Preterm Infants.
Hide Description [Not Specified]
Time Frame Within first 72 hours after birth
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants listed here is greater than the number listed in Participant flow as twin deliveries were not excluded.
Arm/Group Title A (Betamethasone) B (Placebo)
Hide Arm/Group Description:
Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses
Placebo dose IM q 24 hours x 2 doses
Overall Number of Participants Analyzed 49 49
Mean (Standard Deviation)
Unit of Measure: mL/kg
24.8  (8.8) 22.0  (7.9)
2.Primary Outcome
Title Measurements of Respiratory Compliance (Crs) in Preterm Infants.
Hide Description [Not Specified]
Time Frame Within first 72 hours after birth
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants listed here is greater than the number listed in Participant flow as twin deliveries were not excluded.
Arm/Group Title A (Betamethasone) B (Placebo)
Hide Arm/Group Description:
Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses
Placebo dose IM q 24 hours x 2 doses
Overall Number of Participants Analyzed 49 49
Mean (Standard Deviation)
Unit of Measure: mL/cm H2O/kg
1.21  (0.53) 1.01  (0.51)
3.Secondary Outcome
Title FiO2
Hide Description [Not Specified]
Time Frame During initial hospital stay and planned follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants is greater here as it includes all offspring, including twins.
Arm/Group Title A (Betamethasone) B (Placebo)
Hide Arm/Group Description:
Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses
Placebo dose IM q 24 hours x 2 doses
Overall Number of Participants Analyzed 56 56
Measure Type: Count of Participants
Unit of Measure: Participants
FiO2 greater or equal to 0.30
7
  12.5%
16
  28.6%
FiO2 greater or equal to 0.40
5
   8.9%
13
  23.2%
Time Frame [Not Specified]
Adverse Event Reporting Description Number of participants listed here is greater than the number listed in participant flow as this section includes offspring and twins were included.
 
Arm/Group Title A (Betamethasone) B (Placebo)
Hide Arm/Group Description Betamethasone (Celestone) 12 mg IM q 24 hours x 2 doses Placebo dose IM q 24 hours x 2 doses
All-Cause Mortality
A (Betamethasone) B (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/56 (1.79%)   0/56 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
A (Betamethasone) B (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)   0/56 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A (Betamethasone) B (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)   0/56 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cindy McEvoy, MD
Organization: OHSU
Phone: 503-494-0223
EMail: mcevoyc@ohsu.edu
Layout table for additonal information
Responsible Party: Cynthia McEvoy, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00669383     History of Changes
Other Study ID Numbers: OHSU eRIB#1845
First Submitted: April 28, 2008
First Posted: April 30, 2008
Results First Submitted: October 15, 2018
Results First Posted: February 22, 2019
Last Update Posted: February 22, 2019