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Streptococcal Infection and Respiratory Distress in Newborns

NCT00612937 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 13180

Last updated 2018-04-05

No results posted yet for this study

Summary

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.

Conditions

  • Group B Streptococci
  • Respiratory Distress in Newborn

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    lead NIH

Principal Investigators

  • Forbes D Porter, M.D. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-04
Completion
2015-06-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00612937 on ClinicalTrials.gov