- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00518609
Prevention of Infection in Indian Neonates - Phase I Observational Study
July 29, 2014 updated by: NICHD Global Network for Women's and Children's Health
India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates.
Neonatal infection (sepsis) now accounts for 50 percent of deaths among community-born (and 20 percent of mortality among hospital-born) infants.
This study is the first phase of a multi-phase project investigating interventions to prevent neonatal infection in India.
Study Overview
Status
Completed
Conditions
Detailed Description
Invasive bacterial infections encompass clinical diagnoses of septicemia, pneumonia, and meningitis.
Together, these infections are termed "neonatal sepsis" and account for over half of the newborn deaths at the district and sub-district level in India.
Sepsis is the most common (80-90 percent) primary diagnosis for admission in Indian hospitals.
Phase 1 of this study is a prospective, epidemiologic study involving over 1,000 community-based and hospital populations of newborn infants.
It includes identifying all infants born in study hospitals and those brought to the hospitals with suspected sepsis; obtaining blood cultures from these infants and identifying the sepsis-causing bacteria; screening of all bacterial strains isolated from blood cultures for antimicrobial resistance; collecting basic demographic, risk factor, and treatment data on each case; and developing a computer-based system/network for data management.
A village-level surveillance system was put in place to identify women during their pregnancy; monitor pregnancy outcomes; and establish a mechanism for referral of all potentially septic infants to participating clinics or hospitals for evaluation, including the collection of blood cultures.
Potential sources of bacteria causing sepsis will be identified using molecular epidemiologic techniques.
This involves matching septic infants' blood isolates with other colonizing isolates obtained from screening skin, throat, and stool cultures in the infant and skin and vaginal cultures from their mothers.
Study Type
Observational
Enrollment (Actual)
1326
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Orissa
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Bhubaneswar, Orissa, India
- Capital Hospital
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Bhubaneswar, Orissa, India
- Kalinga Hospital
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Rourkela, Orissa, India
- Ispat General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 month (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age <60 days
- A diagnosis of suspected sepsis/pneumonia, based on the presence of at least one of the following symptoms at admission: poor feeding/poor sucking, decreased activity/lethargy, fever, hypothermia, cyanosis, diarrhea, abdominal distension, seizures, apneic spells, sclerema, bleeding, jaundice, tachypnea, chest wall retractions, shock.
- Born in one of the participating hospitals or in village inside catchment area If the screening physician does not suspect sepsis, even in the presence of one or more of the above signs, the baby should not be enrolled.
Exclusion Criteria:
• The presence of major congenital anomalies A major congenital anomaly is defined as any malformation that is felt to be life-threatening or that requires surgical intervention. If the medical officer is uncertain whether an anomaly is life-threatening, he/she should not enroll the infant.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Indian Neonates
All hospitalized neonates (all live born infants <60 days of age, independent of birth weight and gestational age) brought to hospital, with the diagnosis of suspected sepsis.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Pinaki Panigrahi, M.D., University of Maryland School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Study Completion (Actual)
July 1, 2006
Study Registration Dates
First Submitted
August 20, 2007
First Submitted That Met QC Criteria
August 20, 2007
First Posted (Estimate)
August 21, 2007
Study Record Updates
Last Update Posted (Estimate)
July 31, 2014
Last Update Submitted That Met QC Criteria
July 29, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GN 07 Phase I
- U01HD040574 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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