NCT00612937|Completed
Streptococcal Infection and Respiratory Distress in Newborns
Respiratory Distress of the Newborn and Its Relationship to Group B Streptococcal Colonization
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Respiratory Distress of the Newborn and Its Relationship to Group B Streptococcal Colonization
Sponsor study identifier
Secondary identifiers
observational
13,180
1 country
2
Study Start
February 4, 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
June 19, 2015
Date type not reportedThis date has not been verified as actual or estimated.
This study will evaluate whether babies are more at risk of developing breathing problems if their mothers carry group B streptococci (GBS) in vagina/rectum, and whether the breathing problem is due to phospholipids released by the GBS. About one in five pregnant women carry GBS in their vagina/rectum. Mothers who carry these bacteria are given antibiotics during labor to prevent infection in the baby. However, recently it has been suspected that even without blood stream infection, the chemicals released by GBS, called phospholipids, might lead to breathing problems. Women at 32 or more weeks of pregnancy who deliver at Ben Taub Hospital and St. Luke s Episcopal Hospital in Houston, Texas, and Alta Bates Summit Medical Center in Oakland, California, may be eligible for this study. Mothers undergo the following procedures:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 19, 2015
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 4, 2008
Date type not reportedThis date has not been verified as actual or estimated.
February 10, 2008
Actual (reported)February 12, 2008
Actual (reported)June 19, 2015
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Oakland Children's Hospital and Research Center
Oakland, California, 94609, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
McCracken GH Jr. Group B streptococci: the new challenge in neonatal infections. J Pediatr. 1973 Apr;82(4):703-6. doi: 10.1016/s0022-3476(73)80603-1. No abstract available.
Katzenstein AL, Davis C, Braude A. Pulmonary changes in neonatal sepsis to group B beta-hemolytic Streptococcus: relation of hyaline membrane disease. J Infect Dis. 1976 Apr;133(4):430-5. doi: 10.1093/infdis/133.4.430.
Weisman LE, Stoll BJ, Cruess DF, Hall RT, Merenstein GB, Hemming VG, Fischer GW. Early-onset group B streptococcal sepsis: a current assessment. J Pediatr. 1992 Sep;121(3):428-33. doi: 10.1016/s0022-3476(05)81801-3.
Forbes D Porter, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
13,180 participants (actual enrollment reported by the registry).
First Submitted
February 10, 2008
First Posted
February 12, 2008
Study Start
February 4, 2008
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
June 19, 2015
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
April 5, 2018
Record last verified: 2015-06-19
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