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.
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.