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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Respiratory Compliance Functional Residual Capacity Pulmonary Function Testing | Drug: betamethasone Drug: placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 85 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Rescue Antenatal Steroids and Lung Volumes in Preterm Infants |
Study Start Date : | June 2001 |
Actual Primary Completion Date : | July 2007 |
Actual Study Completion Date : | November 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: A
Betamethasone (Celestone) 12 mg intramuscular q 24 hours x 2 doses
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Drug: betamethasone
12 mg IM q 24 hours x 2 doses
Other Name: Celestone |
Placebo Comparator: B
Placebo dose intramuscular q 24 hours x 2 doses
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Drug: placebo
Placebo IM q 24 hours x 2 doses |
- Measurements of Functional Residual Capacity in Preterm Infants. [ Time Frame: Within first 72 hours after birth ]
- Measurements of Respiratory Compliance (Crs) in Preterm Infants. [ Time Frame: Within first 72 hours after birth ]
- FiO2 [ Time Frame: During initial hospital stay and planned follow-up ]

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Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Greater than 14 days after first course of antenatal steroids;
- Less than 34 weeks of gestation;
- Identified by primary physician as continued risk for preterm delivery;
- Informed consent
Exclusion Criteria:
- Major congenital anomalies
- Multiple gestation of triplets or greater
- Mother with insulin dependent diabetes

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669383
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97219 |
Principal Investigator: | Cynthia McEvoy, MD | Oregon Health and Science University |
Responsible Party: | Cynthia McEvoy, Associate Professor of Pediatrics, Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00669383 |
Other Study ID Numbers: |
OHSU eRIB#1845 |
First Posted: | April 30, 2008 Key Record Dates |
Results First Posted: | February 22, 2019 |
Last Update Posted: | February 22, 2019 |
Last Verified: | October 2018 |
premature delivery respiratory distress syndrome |
Betamethasone Anti-Inflammatory Agents Glucocorticoids Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents |