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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

Tracking Information
First Submitted Date  ICMJE April 28, 2008
First Posted Date  ICMJE April 30, 2008
Results First Submitted Date  ICMJE October 15, 2018
Results First Posted Date  ICMJE February 22, 2019
Last Update Posted Date February 22, 2019
Study Start Date  ICMJE June 2001
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
Measurements of respiratory compliance and functional residual capacity in preterm infants. [ Time Frame: Measurements are done within first 72 hours with planned follow-up testing. ]
Change History Complete list of historical versions of study NCT00669383 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
FiO2 [ Time Frame: During initial hospital stay and planned follow-up ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
Other respiratory outcomes and clinical outcomes. [ Time Frame: During initial hospital stay and planned follow-up. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants
Official Title  ICMJE Rescue Antenatal Steroids and Lung Volumes in Preterm Infants
Brief Summary One course of steroids given to a mother before a premature delivery helps the lungs of the premature infant and decreases breathing problems. One course of antenatal steroids is the standard of care for threatened premature deliveries. It is unclear as to how long the benefit of one course of steroids last. The most benefit to the baby's lungs seem to occur if the steroids are given at least 24 hours before but within 7 days of a premature delivery. It is difficult to predict the timing of a preterm delivery so deliveries often do not occur within this time period. We hypothesize that the benefits of the steroids to the lungs wear off if the steroids are given more than 14 days before a preterm delivery, and that in these circumstances an extra course of steroids will help the premature baby's lungs and the premature baby will have less breathing problems as shown by lung function testing.
Detailed Description The primary purpose of this randomized, blinded placebo controlled trial is to quantify and compare measurements of pulmonary function (including respiratory compliance and lung volumes/functional residual capacity) of hospitalized preterm infants whose mothers received an initial course of antenatal corticosteroids, remained undelivered after 14 days and at < 34 weeks of gestation, and were then randomized to either a rescue course of antenatal corticosteroids or to a rescue course of placebo. In addition, follow-up pulmonary function tests, clinical outcomes, growth parameters, and the neurodevelopmental outcome of these infants will be followed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Respiratory Compliance
  • Functional Residual Capacity
  • Pulmonary Function Testing
Intervention  ICMJE
  • Drug: betamethasone
    12 mg IM q 24 hours x 2 doses
    Other Name: Celestone
  • Drug: placebo
    Placebo IM q 24 hours x 2 doses
Study Arms  ICMJE
  • Active Comparator: A
    Betamethasone (Celestone) 12 mg intramuscular q 24 hours x 2 doses
    Intervention: Drug: betamethasone
  • Placebo Comparator: B
    Placebo dose intramuscular q 24 hours x 2 doses
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2018)
85
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2008)
80
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00669383
Other Study ID Numbers  ICMJE OHSU eRIB#1845
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cynthia McEvoy, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE American Lung Association
Investigators  ICMJE
Principal Investigator: Cynthia McEvoy, MD Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP