Prevention of Infection in Indian Neonates - Phase I Observational Study

This study has been completed.
Sponsor:
Collaborators:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
All India Institute of Medical Sciences, New Delhi
TN Medical College, Mumbai
Department of Health and Family Welfare, Orissa
SCB Medical College, Cuttack
Capital Hospital, Bhubaneswar
Ispat General Hospital, Rourkela
Kalinga Hospital, Bhubaneswar
University of Maryland
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00518609
First received: August 20, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted

August 20, 2007
August 20, 2007
July 2003
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No Changes Posted
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Prevention of Infection in Indian Neonates - Phase I Observational Study
Prevention of Infection in Indian Neonates - Phase I Observational Study

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.

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.

Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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Sepsis
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Case: 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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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1326
July 2006
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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.

Both
up to 60 Days
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00518609
GN 07 Phase I, U01 HD040574
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Global Network for Women's and Children's Health Research
  • Bill and Melinda Gates Foundation
  • John E. Fogarty International Center (FIC)
  • National Center for Complementary and Alternative Medicine (NCCAM)
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • National Cancer Institute (NCI)
  • RTI International
  • All India Institute of Medical Sciences, New Delhi
  • TN Medical College, Mumbai
  • Department of Health and Family Welfare, Orissa
  • SCB Medical College, Cuttack
  • Capital Hospital, Bhubaneswar
  • Ispat General Hospital, Rourkela
  • Kalinga Hospital, Bhubaneswar
  • University of Maryland
Principal Investigator: Pinaki Panigrahi, M.D. University of Maryland
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP