As CHWs visit the young infants on a fixed schedule, there is a possibility of missing some infection cases between visits. To capture those cases, CHWs teach household members how to identify signs of infection in a young infant (Table 4) and requests family members to take the infant to a study-designated health care facility if they observe any of these signs. In the study-designated hospitals, a study physician and other study staff assess a self-referred newborn for signs of infection and enroll the infant in ANISA if he/she meets the enrollment criteria (Table 5).
Mothers and other family members are encouraged to hospitalize their ill-appearing newborns so that a study physician can confirm any of the 7 clinical signs of suspected infection. The hospital manages the admitted young infants according to the hospital policy. If caregivers refuse to hospitalize their sick young infants, study physicians provide standard outpatient care for the illness. A combination of penicillin and aminoglycoside (penicillin/ampicillin and gentamicin) is typically used to treat suspected infection.2,27–31 For meningitis, a third-generation cephalosporin (ceftriaxone/cefotaxime) is used with or without an aminoglycoside. The results of blood and cerebrospinal fluid cultures are provided to treating physicians.
Supervisory staff members conduct a complete verbal autopsy for each young infant who dies within the follow-up period (0–59 days),32–37 using validated WHO Verbal Autopsy Forms.37 Two physicians then independently review the completed forms. If the physicians do not concur, a third physician reviews the information and makes a conclusion on the cause of death.
Consent is requested from parents or caregivers at 2 points. Informed verbal consent is taken at the time of registering a pregnant woman in the study. Informed written consent is requested at the time of collecting specimens from a sick young infant with suspected infection. We obtained ethical clearance for the study from the ethical review committees or internal review boards of all the organizations involved in this study, and they have reviewed and approved the study protocol and consent and data collection forms. These organizations include the Bangladesh Institute of Child Health, WHO, Johns Hopkins Bloomberg School of Public Health, Aga Khan University, International Centre for Diarrhoeal Disease Research, Bangladesh, Christian Medical College and the Asian Institute of Public Health.
The ANISA infection surveillance protocol is designed to capture the population-based incidence, etiology and risk factors for community-acquired neonatal infections in South Asia. We expect that through this study we will able to report the etiology of young infant infections in South Asia to guide the future treatment policy for this group and help to develop strategies to reduce the burden of young infant infections across the world. We believe that the methodology described in this article will also be useful to design future population-based studies in resource-poor areas.
The authors thank the experts who provided their valuable thoughts in designing this protocol, the families who participated in this study and the project staff who are contributed their time, experience and hard work to make the study successful.
ANISA Methods Group: A. S. M. Nawshad Uddin Ahmed, FCPS, Belal Hossian, MSc, Maksuda Islam, BA, Tanvir Hossain, MSc, Qazi Sadeq-ur Rahman, MSc, Maureen Helen Diaz, PhD, Jonas Winchell, PhD, Nong Shang, PhD, Derrick Crook, MRCP, Vishawjeet Kumar, MPH, Aarti Kumar, MS, Stephen P. Luby, MD, Luke Mullany, PhD, Mathuram Santosham, MD, Yoonjoung Choi, PhD, Shahida M Qureshi, MSc, Imran Ahmed, MSc, Sheraz Ahmed, MBBS, Arif Mahmud, MBBS, Nazma Begum, MA, and Stephanie J. Schrag, DPhil.
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