CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13,180 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00612937
NCT00612937N/ACompleted

Respiratory Distress of the Newborn and Its Relationship to Group B Streptococcal Colonization

In Brief

An observational study for Group B Streptococci and Respiratory Distress in Newborn. Completed, enrolled 13,180 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 12, 2008
Enrollment StartFeb 4, 2008
Study CompletionJun 19, 2015
TodayJul 2, 2026
Posted 18.4 years ago