Streptococcal Infection and Respiratory Distress in Newborns
Completed
Conditions studied: Group B Streptococci, Respiratory Distress in Newborn
In brief
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: * Vaginal/rectal GBS culture. A sample is collected from the lower vagina and rectum using a cotton swab upon admission to labor and delivery. * Blood collection to test for phospholipids. A blood sample is obtained from the mothers at the time of routine blood drawing during labor, and a blood sample is obtained from the umbilical cord (after delivery). * Collection of health information from the medical record. Newborns undergo the following procedures: * GBS culture. Samples are collected from cotton swabs of the ears, navel, anus and throat to test for GBS bacteria. * A small amount of blood from newborns is obtained for phospholipids test when the newborns have blood drawn for other tests. * Collection of health information from the medical record.
Key facts
- Study ID
- NCT00612937
- Run by
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- People needed
- 13180
- Starts
- 2008-02-04
- Expected to finish
- 2015-06-19
- Last updated by the study team
- 2018-04-05
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Newborns with severe or fatal congenital anomaly such as gastroschisis, congenital diaphragmatic hernia, tracheoesophageal fistula, transition of the great arteries, coarctation of aorta, myelomeningocele, and omphalocele will be excluded from the study.
Where it is running
- Oakland Children's Hospital and Research Center — Oakland, California, United States
- Baylor College of Medicine — Houston, Texas, United States
Full record on ClinicalTrials.gov
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