Clinical trial NCT00518609: Prevention of Infection in Indian Neonates - Phase I Observational Study
Official title: Prevention of Infection in Indian Neonates - Phase I Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: Neonatal
Sepsis
Global Network
Antibiotics
India
International
Maternal and child health
Lead sponsor: NICHD Global Network for Women's and Children's Health
Sponsor class: NETWORK
Collaborators: name: Global Network for Women's and Children's Health Research
name: Bill and Melinda Gates Foundation
name: Fogarty International Center of the National Institute of Health
name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institute of Dental and Craniofacial Research (NIDCR)
name: National Cancer Institute (NCI)
name: RTI International
name: All India Institute of Medical Sciences
name: TN Medical College, Mumbai
name: Department of Health and Family Welfare, Orissa
name: SCB Medical College, Cuttack
name: Capital Hospital, Bhubaneswar
name: Ispat General Hospital, Rourkela
name: Kalinga Hospital, Bhubaneswar
name: University of Maryland
First posted: 2007-08-21
Enrollment: 1326
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bhubaneswar
country: India
facility: Capital Hospital
state: Orissa
city: Bhubaneswar
country: India
facility: Kalinga Hospital
state: Orissa
city: Rourkela
country: India
facility: Ispat General Hospital
state: Orissa
Study officials:
affiliation: University of Maryland, Baltimore
name: Pinaki Panigrahi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: