The skin is a potential source for invasive infections in neonates from developing countries such as Bangladesh, where the level of environmental contamination is exceedingly high. A randomized controlled trial was conducted from 1998 to 2003 in the Special Care Nursery of a tertiary hospital in Bangladesh to test the effectiveness of topical emollient therapy in enhancing the skin barrier of preterm neonates less than 33 weeks of gestational age. In the initial months of the study, the infection and mortality rates were noted to be unacceptably high. Therefore, an infection control program was introduced early in the trial to reduce the rate of nosocomial infections.
After a comprehensive review of neonatal care practices and equipment to identify sources of nosocomial infections, a simple but comprehensive infection control program was introduced that emphasized education of staff and caregivers about measures to decrease risk of contamination, particularly hand-washing, proper disposal of infectious waste, and strict asepsis during procedures, as well as prudent use of antibiotics.
Infection control efforts resulted in declines in episodes of suspected sepsis (47%), cases of culture-proven (61%) sepsis, patients with a clinical diagnosis of sepsis (79%), and deaths with clinical (82%) or culture-proven sepsis (50%).
The infection control program was shown to be a simple, low-cost, low-technology intervention to reduce substantially the incidence of septicemia and mortality in the nursery.
Nosocomial infections are a principal cause of morbidity and mortality among hospitalized neonates in developing countries.1, 2, 3 The incidence of sepsis in premature infants in developing countries is particularly high, estimated at 30 to 60%,4, 5 and mortality is 40 to 70%.6, 7, 8, 9, 10, 11 Limited information is available, however, from many developing countries on the impact of strategies to prevent and control these infections.
Model infection control programs to detect and prevent nosocomial infections and minimize the emergence and spread of antibiotic-resistant strains within hospital nurseries have been established in developed countries, and some countries in Latin America have adapted these programs based on local needs and resources.12, 13 Many aspects of these programs, however, are not readily applicable to health-care settings with more limited resources, such as many health facilities in south Asia and sub-Saharan Africa, where the majority of global neonatal deaths occur. Infection control programs should incorporate two broad strategies fundamental to the control of nosocomial infections: reducing bacterial transmission within the nursery through infection control interventions, and reducing selective pressure for the emergence of antibiotic resistance through promotion of rational use of antibiotics and control of their misuse. Although resource limitations will restrict the scope of infection control programs in many settings, the ability to use antibiotics rationally and to implement simple infection control procedures, such as hand-washing, are not beyond the reach of health-care facilities with even very limited resources.
In the course of implementing an intervention trial at Dhaka Shishu Hospital, Bangladesh, to assess the impact of topical emollient therapy to enhance skin barrier function on the incidence of infections in preterm infants, the results of which will be reported elsewhere,14 we found alarmingly high rates of nosocomial infections and mortality. This led to the development and evaluation of the impact of a low-cost infection control program, including antibiotic use guidelines and emphasis on hygiene, on the incidence of nosocomial infections and neonatal mortality rates among preterm infants in the Special Care Nursery.
Study Setting and Patient Population
A randomized, controlled intervention trial was initiated in December 1998 at Dhaka Shishu Hospital, Bangladesh, aimed to reduce infections in preterm infants less than 33 weeks gestational age through topical therapy with skin-barrier-enhancing emollients.15, 16, 17 Dhaka Shishu Hospital is the largest tertiary-level pediatric hospital in Bangladesh, with 345 beds, including 16 cribs and eight isolettes in the Special Care Nursery. Patients come to Shishu Hospital from all over Bangladesh, although the principal catchment area includes a population of approximately 16 million from Dhaka and adjoining districts.
Gestational age of neonates admitted to the Hospital was determined by maternal dates and Ballard and Dubowitz criteria;18, 19 the average of the three values was used. Infants were enrolled in the study if their average gestational age was less than 33 weeks, their chronological age was less than 72 hours, and parental informed consent was obtained. Exclusion criteria included: (1) admission for a major surgical procedure attended by a high rate of infectious complications; (2) clinically evident skin infection (confirmed by surface culture); (3) generalized skin disease likely to produce a defect in epidermal barrier function; (4) a structural defect of the skin involving greater than 5% body surface area (e.g., congenital blistering disorder); (5) a major congenital anomaly likely to predispose to infection; or (6) known immunodeficiency.
During the initial phase of the trial, nosocomial infection and mortality rates were found to be unacceptably high at 35 and 61%, respectively, and the study Data Safety and Monitoring Board encouraged the investigators to assess and address the situation. Previously, epidemic outbreaks of nosocomial infections had occurred in the Special Care Nursery due to Flavobacterium meningosepticum, Salmonella typhi Group B, and Klebsiella pneumoniae.
Infection Control Program
Given the high rate of nosocomial infections and mortality among preterm neonates in the Special Care Nursery, an infection control program was introduced in January 1999. In the first phase, a review of neonatal care practices and equipment in the Nursery was undertaken to identify potential sources of nosocomial infections, including the staff, particularly their hands, and equipment used in patient care, including incubators, nasal prongs, and suction devices. Antibiotic use and intravenous catheter care were also reviewed. Based on the findings of the review, educational sessions were held with the nurses in the Nursery, who, in turn, held daily sessions with patient family members (generally the mother, or, if the mother was unavailable, another female relative) who resided in the unit and assisted in caring for their own hospitalized newborn. Emphasis was placed initially on personal hygiene of the nurses and caregivers, particularly hand-washing, nail care, and bathing. Emphasis was also placed on minimum handling of very preterm infants, newborn bathing techniques to minimize risk for hypothermia, and promotion of breastfeeding. Nurses were also taught clean umbilical cord care and regular shifting of infant posture and mild physiotherapy. Ward physicians were given refresher training on early recognition and culturing of infants with suspected sepsis, and appropriate antibiotic therapy.
In 2000, the Hospital formed an Infection Control Committee comprising the Hospital Director, Epidemiologist, Head of Microbiology, Nursing Supervisor, and a Staff Nurse. Further measures the Committee took to prevent nosocomial infections included:
Hand-washing: A freestanding wash basin containing Savlon antiseptic was set at an accessible place near the sink in the ward to further encourage hand-washing by doctors and nurses. A poster was placed at the basin as a reminder of the ideal way to wash hands.
Waste disposal: Colored buckets were placed in the ward; blue buckets for normal waste and red for potentially infectious or dangerous waste such as syringes, needles, broken tubes, etc.
Introduction of disposable needles: Private-paying patients (20% of admissions) were asked to provide disposable syringes and needles; for non-paying patients, disposable needles were donated by the hospital, used and discarded, although in some cases, due to lack of resources, syringes were used more than once (after cleaning and boiling).
Visitation: Restrictions were placed on the number of visitors in the wards, and visitors were required to wash their hands before going to a patient's bedside.
Cohorting: Surgical postoperative patients with wound infections were isolated from other patients.
Care of intravenous and urinary catheters: The staff was trained in standard guidelines for use of these devices and an infection control nurse was appointed to monitor their use.
Training and supervision: Weekly classes on infection control procedures on the wards were conducted by the Nursing Supervisor with nurses and caregivers. The head of the Infection Control Committee also conducted classes on a regular basis with the nurses, with special reference to specimen collection, aseptic measures, and basics of microbiology related to nosocomial infections. Practices were reinforced through daily supervision by the Nursing Supervisor.
In a third stage of the infection control program begun in 2001, a new Nursing Supervisor with interest and training in infection control began to assemble groups of three to four mothers and other caregivers on the ward to reinforce health and infection control messages. A log book of these sessions was maintained, including documentation of the issues discussed. Emphasis was further placed on increasing awareness of the importance of infection control and personal hygiene. Nurses inspected the mother's hygiene, including the fingernails, each day. Caregivers were given a clean gown each day to wear at the bedside when handling the baby, and were given a box in which to keep dirty items.
Hand-washing was highlighted as the most important measure to prevent nosocomial infections. Caregivers and staff were instructed to wash hands at the sink with soap and water, followed by hexisol (2.5% v/v chlorhexidine gluconate solution in 70% w/w isopropyl alcohol) before handling the babies. A towel at the sink for use by caregivers was changed each day; prior to the intervention, this was not regularly monitored. Study nurses and physicians began to use disposable tissues, rather than the towel, to dry their hands.
Additional actions taken as part of the third stage of the infection control program included: (1) a separate suction device was designated for each baby and placed at the bedside; (2) incubators were cleaned with soap and water and Savlon, and dried in-between patients and at least once per week if the baby was in the incubator for a prolonged period; (3) emphasis was placed on keeping the floors clean; (4) new bed mattresses were purchased without crevices in which “dirt” could accumulate, and were cleaned with Savlon every day; (5) nurse workload was restructured so that one nurse would feed all the babies and a different nurse would change and clean the beds, rather than sharing duties; (6) further instruction and supervision was provided to ensure that invasive procedures (e.g., venipuncture, catheter placement, lumbar puncture) were performed using strict asepsis, including use of iodine and alcohol (not just alcohol as practiced previously); and (7) babies with clinically suspected or bacteriological-proven septicemia were cohorted, if possible. Finally, judicious antibiotic use was reviewed, including initial empiric use of ampicillin and gentamicin as first-line treatment for suspected sepsis, prompt discontinuation of antibiotics if cultures were negative and the baby was well clinically, and appropriate and prompt adjustment of the antibiotic regimen according to the sensitivity pattern of the isolate.
Nosocomial infection, or confirmed hospital-acquired sepsis, the primary outcome measure, was defined as a noncontaminated (e.g., Diphtheroids and Micrococcus spp. were excluded) positive blood or cerebrospinal fluid (CSF) culture taken after 3 or more days of hospitalization, where the culture did not grow the same organism as the most recent previous culture in the same infant (i.e., cultures that were positive on the basis of persistent infection were excluded). If an infant had both a positive CSF and a positive blood culture, or two positive blood cultures on the same day, only one nosocomial infection on that day was counted.
Suspected sepsis was defined as any episode of illness for which blood cultures were drawn. A patient was identified as having clinical sepsis if, on the basis of clinical judgment, the attending physician assigned sepsis as a final diagnosis at the end of hospitalization.
All analyses were conducted using STATA 7.0 statistical software (Stata Corporation, College Station, TX, USA).
Epidemics. In 1998, before our study was initiated, nosocomial outbreaks of group B Salmonella accounted for 58 documented cases of nosocomial infection in the neonatal ward, whereas 12 such cases occurred in 1999, and there were no outbreaks of Salmonella infection in 2000. Similarly, outbreaks with K. pneumoniae accounted for 62 infections in 1999, 14 in 2000, and none in 2001.
Sporadic infections. Significant declines from 1999 to 2001 were found in cases of suspected sepsis [i.e., total number of cultures obtained (Figure 1) and number of cultures obtained per patient (data not shown) for suspected sepsis] and culture-proven sepsis [i.e., total number of positive cultures (Figure 1) and proportion of cultures obtained per patient that were positive (data not shown)]. Number of patients diagnosed with clinical sepsis (Figure 2) was also reduced. Mortality declined over the study period, with reduced numbers of patients who died with clinical sepsis and confirmed sepsis (Figure 3).
This study has important implications for infection control and antibiotic use policies in neonatal care units in developing countries. Despite the proven benefit of infection control practices in developed country nurseries, there is little documentation of successful infection control efforts in the developing world, where rates of nosocomial infections remain unacceptably high and contribute to high mortality rates due to sepsis in health facilities. The high mortality and infection rates and alarmingly high rates of antibiotic resistance that we encountered among the nosocomial isolates in the Special Care Nursery at our study site2 led us to institute low-technology, low-cost infection control procedures, with encouraging results that may be widely applicable to other developing country neonatal care settings.
We demonstrated that a relatively simple infection control program, aimed at fundamental sources of nosocomial infection identified through a systematic review of the care practices and equipment in the nursery, can have a marked impact on nosocomial infection and mortality rates in hospitalized preterm infants. Some of the key elements of the program appeared to be designation of an infection control nurse on the ward and formation of a hospital Infection Control Committee to oversee training activities and stimulate ownership of the problem on the part of the staff; systematic review and planning to redress principal potential sources of environmental contamination in the nursery; regular training and supervision of nurses and caregivers on routine infection control practices, particularly hand-washing; and focused attention on judicious use of antibiotics. Little to no cost was required to implement the program except for materials such as cleansers and time for the various educational activities with staff and caregivers. The will and efforts of key individuals, particularly the Nursing Supervisor, to improve infection control practices was pivotal in achieving success. Other nurseries throughout the developing world could readily implement such a program.
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This study was supported by the Thrasher Research Fund, the Johns Hopkins Family Health and Child Survival Cooperative Agreement with the United Sates Agency for International Development, the Society for Pediatric Dermatology and Save the Children USA through a grant from the Bill and Melinda Gates Foundation. We thank the members of the Data Safety and Monitoring Board (DSMB) for the parent intervention trial for their encouragement to pursue infection control measures in the nursery. DSMB members included Kim Mulholland, University of Melbourne, Barbara Stoll, Emory University, and William Blackwelder (retired), National Institutes of Health (USA). We thank Rachel Haws for editorial assistance in preparation of the manuscript, and Maksuda Islam for microbiological technical assistance.
Presented in part at 10th Asian Conference on Diarrhoeal Diseases and Nutrition, Dhaka, Bangladesh, 2004; and Third National Annual Conference and Scientific Session, Bangladesh Neonatal Forum, Dhaka, Bangladesh, 2002.
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Darmstadt, G., Nawshad Uddin Ahmed, A., Saha, S. et al. Infection Control Practices Reduce Nosocomial Infections and Mortality in Preterm Infants in Bangladesh. J Perinatol 25, 331–335 (2005). https://doi.org/10.1038/sj.jp.7211283
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