Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
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. According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 13,180 participants |
| Start Date | 2008-02-04 |
| Est. Completion | 2015-06-19 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT00612937 record still lists
NCT00612937 is an observational study that tracks outcomes without assigning an intervention. Its 13,180 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT00612937 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05991453 · 13,000 participants · NA
Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
- NCT07177352 · 13,000 participants · Phase 3
Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies
- NCT07028398 · 12,990 participants · NA
CMSL Ambulatory Sensitive Condition Nudge Study 2
- NCT05141396 · 13,400 participants · NA
Telehealth-Enabled, Real-time Audit and Feedback for Clinician AdHerence (TEACH)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI