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NCT00612937 · ClinicalTrials.gov registry record

Streptococcal Infection and Respiratory Distress in Newborns

A clinical trial, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Completed
Registry status
13,180
Enrollment target

NCT00612937 is a clinical trial that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 13,180 participants.

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The verdict

NCT00612937 has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

COMPLETED
Registry status
13,180 participants
Enrollment target

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.

Trial Details

FieldValue
Enrollment Target 13,180 participants
Start Date 2008-02-04
Est. Completion 2015-06-19

What the Registry Record Tells You About NCT00612937

The ClinicalTrials.gov registry entry for NCT00612937 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 13,180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT00612937 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00612937 about?

NCT00612937 is a clinical study titled "Streptococcal Infection and Respiratory Distress in Newborns". 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/rect...

What is the current status of trial NCT00612937?

This trial is currently completed. The enrollment target is 13,180 participants. The study started on 2008-02-04. Estimated completion is 2015-06-19.

Who is sponsoring clinical trial NCT00612937?

This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.

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