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Prevention of Infection in Indian Neonates - Phase I Observational Study

Phase 1
60 Days
Not Enrolling

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Trial Information

Prevention of Infection in Indian Neonates - Phase I Observational Study

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.

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.

Type of Study:


Study Design:

Observational Model: Defined Population, Observational Model: Natural History, Time Perspective: Longitudinal, Time Perspective: Prospective

Principal Investigator

Pinaki Panigrahi, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland


United States: Federal Government

Study ID:

GN 07 Phase I



Start Date:

July 2003

Completion Date:

July 2006

Related Keywords:

  • Sepsis
  • Neonatal
  • Sepsis
  • Global Network
  • Antibiotics
  • India
  • International
  • Maternal and child health
  • Sepsis