Neonatal pneumonia: comparison of 4 vs 7 days of antibiotic therapy in term and near-term infants.

OBJECTIVE: To compare a 4-day course of antibiotic therapy to a 7-day course in selected term and near-term neonates with pneumonia.
METHODS: The diagnosis of pneumonia was made in neonates admitted to the normal Newborn Nursery (NBN) who later had signs of respiratory distress and whose chest radiographs were consistent with pneumonia. Infants were excluded if any of the following was present: moderate or thick meconium-stained amniotic fluid, prior antibiotic therapy > 24 hours, or need for supplemental oxygen > 8 hours. Infants who were asymptomatic after 48 hours of antibiotic therapy were prospectively randomized to a 4-day group (n = 35) or a 7-day group (n = 38). Infants in the 4-day group were observed in the hospital for 24 hours following cessation of antibiotics and were seen in follow up within several days of discharge.
RESULTS: The groups were comparable with regard to demographic factors, duration of rupture of membranes, and incidence of maternal chorioamnionitis. Median postnatal age at the time of identification of respiratory distress symptomatology was 19 hours (range 0.5 to 55 hours) in the 4-day group and 12 hours (range 1 to 72 hours) in the 7-day group. No study infants had a positive blood culture. Mean reduction in length of hospitalization was 2.1 days, with estimated savings of greater than US$700 per shortened hospitalization. Two infants in the 4-day group developed tachypnea during the 24-hour observation period. However, no infants were rehospitalized for sepsis or pneumonia following discharge. With 95% confidence, the true rate of success for the 4-day group was at least 92%.
CONCLUSION: Four days of antibiotic therapy plus a 24-hour period of observation for selected cases of neonatal pneumonia appears to be comparable to 7 days of therapy. It is important to note that newborns in our institution receive a single dose of penicillin soon after birth as part of our group B streptococcal sepsis prophylaxis program, and all infants in this study received prophylaxis prior to the onset of respiratory symptoms. Furthermore, only infants who were asymptomatic after 48 hours of antibiotic therapy were included in this study, and a 24-hour observation period at the end of the 4-day course was required. These qualifications should be taken into account before use of this approach is considered, and additional studies are necessary to further establish its safety and benefits.

RCT Entities:   Population Interventions Outcomes