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Intravenous Injections in Neonatal Mice
Published on: November 11, 2014
Palivizumab use in very premature infants in the neonatal intensive care unit
Shou-Yien Wu1, Joel Bonaparte, Suma Pyati
1Division of Neonatology, Department of Pediatrics, John H. Stroger, Jr. Hospital of Cook County, Chicago, Illinois 60612, USA. sywhuang@comcast.net
Insights
Very premature infants require multiple palivizumab doses to achieve protective serum levels against RSV. Optimal concentrations were sustained only after the second dose, highlighting the need for further research on dosing strategies for this vulnerable population.
Area of Science:
- Neonatal Medicine
- Pediatric Infectious Diseases
- Pharmacokinetics
Background:
- Respiratory Syncytial Virus (RSV) poses a significant threat to premature infants.
- Palivizumab is a monoclonal antibody used for RSV prophylaxis.
- Determining optimal dosing for very premature infants is crucial for effective protection.
Purpose of the Study:
- To assess the ability of young hospitalized premature infants (born ≤30 weeks gestational age) to achieve protective serum palivizumab levels.
- To evaluate palivizumab pharmacokinetics in this high-risk neonatal population.
Main Methods:
- Palivizumab (15 mg/kg) was administered intramuscularly every 28 days to hospitalized premature infants.
- Serum palivizumab concentrations were measured at midpoint (14 days) and trough (28 days) after each dose.
- Infants were born at a mean gestational age of 27.5 weeks and weighed 928g.
Main Results:
- After the first dose, 71% of infants achieved optimal midpoint concentrations (>40 µg/mL).
- Trough concentrations before the second dose dropped significantly, with only 23% maintaining optimal levels.
- Midpoint and trough concentrations increased after the second and third doses, with all infants achieving optimal levels after the third dose.
Conclusions:
- Very premature infants may not achieve sustained protective palivizumab serum concentrations until after the second dose.
- A high percentage (77%) had sub-optimal trough levels before the second dose.
- Further studies are needed to optimize palivizumab dosing intervals and timing for this vulnerable group.
Objective:
The purpose of this study was to determine the ability of young hospitalized premature (born < or =30 weeks' gestational age) infants to achieve serum levels of palivizumab that are protective against RSV infection.
Methods:
Palivizumab, 15 mg/kg per dose intramuscularly, was administered every 28 days to stable premature infants who were hospitalized in the neonatal intensive care unit starting at 1 month of postnatal life. Palivizumab concentrations were assayed in serum samples that were drawn from infants who remained in the hospital at 14 days (midpoint concentration) and at 28 days (trough concentration) after each dose was administered.
Results:
The gestational age of the 24 infants who were enrolled was 27.5 +/- 1.8 weeks (mean +/- standard deviation), and birth weight was 928 +/- 159 g. Midpoint palivizumab concentrations in the 24 infants after the first dose were 45.6 +/- 13.0 microg/mL; 71% (17 of 24) of the infants maintained optimal palivizumab concentrations (> or =40 microg/mL). The concentrations dropped subsequently; trough concentrations just before the second dose were 32.2 +/- 10.5 microg/mL, and only 23% (5 of 22) of the infants had concentrations in the optimal range. Sixteen infants were given 2 doses and 6 were given three doses of palivizumab while in the neonatal intensive care unit. Midpoint concentrations after the second dose were significantly higher than those after the first dose. Likewise, trough concentrations before the third dose were 51.9 +/- 7.8 microg/mL and higher than those before the second dose; the concentrations were >40 microg/ml in all 6 infants tested.
Conclusions:
Very premature infants had sustained optimal protective serum concentrations only after the second dose of palivizumab; 77% of infants tested had trough concentrations <40 microg/mL before the second dose. Additional studies are needed to establish the optimal timing of the initial dose and optimal dosing interval of palivizumab in this most vulnerable population.
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