Prevention of Infection in Indian Neonates - Phase I Observational Study
2 other identifiers
observational
1,326
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2003
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 20, 2007
CompletedFirst Posted
Study publicly available on registry
August 21, 2007
CompletedJuly 31, 2014
July 1, 2014
August 20, 2007
July 29, 2014
Conditions
Keywords
Study Arms (1)
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NICHD Global Network for Women's and Children's Healthlead
- Global Network for Women's and Children's Health Researchcollaborator
- Bill and Melinda Gates Foundationcollaborator
- Fogarty International Center of the National Institute of Healthcollaborator
- National Center for Complementary and Integrative Health (NCCIH)collaborator
- National Institute of Dental and Craniofacial Research (NIDCR)collaborator
- National Cancer Institute (NCI)collaborator
- RTI Internationalcollaborator
- All India Institute of Medical Sciencescollaborator
- TN Medical College, Mumbaicollaborator
- Department of Health and Family Welfare, Orissacollaborator
- SCB Medical College, Cuttackcollaborator
- Capital Hospital, Bhubaneswarcollaborator
- Ispat General Hospital, Rourkelacollaborator
- Kalinga Hospital, Bhubaneswarcollaborator
- University of Marylandcollaborator
Study Sites (3)
Capital Hospital
Bhubaneswar, Odisha, India
Kalinga Hospital
Bhubaneswar, Odisha, India
Ispat General Hospital
Rourkela, Odisha, India
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pinaki Panigrahi, M.D.
University of Maryland, Baltimore
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2007
First Posted
August 21, 2007
Study Start
July 1, 2003
Study Completion
July 1, 2006
Last Updated
July 31, 2014
Record last verified: 2014-07