Determination of extended-interval gentamicin dosing for neonatal patients in developing countries

Pediatric Infectious Disease Journal

Volumn 26, Issue 6, 2007, Pages 501-507

  Darmstadt, Gary L ^a   Hossain, M Monir ^b   Jana, Atanu Kumar ^c   Saha, Samir K ^b   Choi, Yoonjoung ^a   Sridhar, S ^c   Thomas, Niranjan ^c   Miller Bell, Mary ^d   Edwards, David ^e   Aranda, Jacob ^e   Willis, Jeffrey ^a   Coffey, Patricia ^f  

^a JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^b DHAKA SHISHU HOSPITAL   (Bangladesh)

^c CHRISTIAN MEDICAL COLLEGE   (India)

^d DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e WAYNE STATE UNIVERSITY   (United States)

^f PATH   (United States)

Author keywords

Developing country; Extended interval; Gentamicin; Neonatal sepsis; Uniject

Indexed keywords

AMPICILLIN; GENTAMICIN;

ARTICLE; BANGLADESH; CLINICAL TRIAL; DEVELOPING COUNTRY; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SAFETY; FEMALE; HEARING; HOSPITAL DISCHARGE; HUMAN; INDIA; KIDNEY FUNCTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEPHROTOXICITY; NEWBORN; NEWBORN INTENSIVE CARE; NEWBORN SEPSIS; OTOTOXICITY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROSPECTIVE STUDY; STEADY STATE;

ANTI-BACTERIAL AGENTS; BACTERIAL INFECTIONS; BANGLADESH; DEVELOPING COUNTRIES; FEMALE; GENTAMICINS; HEARING TESTS; HOSPITALIZATION; HUMANS; INDIA; INFANT, NEWBORN; INJECTIONS, INTRAVENOUS; INTENSIVE CARE UNITS, NEONATAL; KIDNEY FUNCTION TESTS; MALE; SEPSIS; SERUM;

EID: 34249827250     PISSN: 08913668     EISSN: None     Source Type: Journal    
DOI: 10.1097/INF.0b013e318059c25b     Document Type: Article

References (52)

1. Black R, Morris S, Bryce J. Where and why are 10 million children dying every year. Lancet. 2003;361:2226-2234.
2. Lawn J, Cousens S, Zupan J. Four million neonatal deaths: where? when? why. Lancet. 2005;365:891-900.
3. Save the Children Federation. World Health Organization 2001 estimates. In: Saving Newborn Lives: State of the World's Newborns. Washington, DC: Save the Children Federation; 2001:1-49.
4. Darmstadt G, Bhutta Z, Cousens S, et al. Evidence-based, cost-effective interventions: how many newborn babies can we save. Lancet. 2005;365:977-988.
5. Darmstadt G, Black R, Santosham M. Research priorities and postpartum care strategies for the prevention and optimal management of neonatal infections in less developed countries. Pediatr Infect Dis J. 2000;19:739-750.
6. Bang AT, Bang RA, Baitule SB, et al. Effect of home-based neonatal care and management of sepsis on neonatal mortality: field trial in rural India. Lancet. 1999;354:1955-1961.
7. Bang A, Bang R, Reddy H, et al. Reduced incidence of neonatal morbidities: effect of home-based neonatal care in rural Gadchiroli, India. J Perinatol. 2005;25:S51-S61.
8. Stoll B. The global impact of neonatal infection. Clin Perinatol. 1997;24:1-21.
9. Bang A, Bang R, Stoll B, et al. Is home-based diagnosis and treatment of neonatal sepsis feasible and effective? Seven years of intervention in the Gadchiroli field trial (1996 -2003). J Perinatol. 2005;25:S62-S71.
10. Baqui A, El Arifeen S, Seraji M, et al. Causes and timing of neonatal infectious morbidity and mortality in Sylhet district, Bangladesh: implications for programs abstract-. Pediatr Acad Soc. In press.
11. Stoll B. Neonatal Infections: A Global Perspective. 5th ed. Philadelphia: WB Saunders; 2001.
12. Management of the child with serious infection or severe malnutrition: guidelines for care at the first referral level in developing countries. Geneva: World Health Organization; 2000. Document No. WHO/FCH/CAH/00.1.
13. Contopoulos-Ioannidis D, Giotis N, Baliatsa D, et al. Extended-interval aminoglycoside administration for children: a meta-analysis. Pediatrics. 2004;114:111-118.
14. PATH. HealthTech Historical Profile: The Uniject Device. Seattle, Washington: PATH; 2000:1-12.
15. Bang AT, Bang RA, Baitule S, Deshmukh M, Reddy MH. Burden of morbidities and the unmet need for health care in rural neonates - a prospective observational study in Gadchiroli, India. Indian Pediatr. 2001;38:952-965.
16. Arifeen SE. Birth weight, intrauterine growth retardation and prematurity: a prospective study of infant growth and survival in the slums of Dhaka, Bangladesh. Doctor of Public Health Dissertation, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA, 1997.
17. Agarwal G, Rastogi A, Pyati S, et al. Comparison of once-daily versus twice daily gentamicin dosing regimens in infants >2500 g. J Perinatol. 2002;22:268-274.
18. De Alba R, Castillo G, Manzanares S, et al. Once daily gentamicin dosing in neonates. Pediatr Infect Dis J. 1998;17:1169-1171.
19. Hayani K, Hatzopoulos F, Frank A, et al. Pharmacokinetics of once-daily dosing of gentamicin in neonates. J Pediatr. 1997;131:76-80.
20. Krishnan L, George S. Gentamicin therapy in preterms: a comparison of two dosage regimens. Indian Pediatr. 1997;34:1075-1080.
21. Lungergan F, Glasscock G, Kim E, et al. Once-daily gentamicin dosing in newborn infants. Pediatrics. 1999;103:1228-1234.
22. Rastogi A, Agarwal G, Pyati S, et al. Comparison of two gentamicin dosing schedules in very low birth weight infants. Pediatr Infect Dis J. 2002;21:234-240.
23. Skopnik H, Heimann G. Once daily aminoglycoside dosing in full term neonates. Pediatr Infect Dis J. 1995;14:71-72.
24. Soloman R, Kuruvilla K, Job V, et al. Randomized controlled trial of once vs. twice daily gentamicin therapy in newborn. Indian Pediatr. 1999;36:133-137.
25. Thureen P, Reiter P, Gresores A, et al. Once- versus twice-daily gentamicin dosing in neonates >34 weeks gestation: cost-effectiveness analysis. Pediatrics. 1999;103:594-598.
26. Rudd PT, Hughes EA, Placzek MM, Hodes DT. Reference ranges for plasma creatinine during the first month of life. Arch Dis Child. 1983;58:212-215.
27. Bueva A, Guignard JP. Renal function in preterm neonates. Pediatr Res. 1994;36:572-577.
28. Miall LS, Henderson MJ, Turner AJ, et al. Plasma creatinine rises dramatically in the first 48 hours of life in preterm infants. Pediatrics. 1999;104:e76.
29. Choker G, Gouyon J. Diagnosis of acute renal failure in very preterm infants. Biol Neonate. 2004;86:212-216.
30. Finney H, Newman D, Thakkar H, et al. Reference ranges for plasma cystatin C and creatinine measurements in premature infants, neonates and older children. Arch Dis Child. 2000;82:71-75.
31. Chambers H. Antimicrobial Agents: The Aminoglycosies. 10th ed. New York: McGraw-Hill; 2002.
32. Saez-Llorens X, McCracken G. Clinical Pharmacology of the Antibacterial Agents. 5th ed. Philadelphia: WB Saunders; 2001.
33. Mulhall A. Antibiotic treatment of neonates: does route of administration matter. Dev Pharmacol Ther. 1985;8:1-8.
34. Shahidullah M, Talukder M, Chowdhury A, et al. Serum levels of gentamicin at peak and trough in neonates and infants. Indian J Pediatr. 1991;58:217-221.
35. Gal P, Ransom J, Weaver R. Gentamicin in neonates: the need for loading doses. Am J Perinatol. 1990;7:254-257.
36. Sawchuk R, Zaske D, Cipolle R, et al. Kinetic model for gentamicin dosing with the use of individual patient parameters. Clin Pharmacol Ther. 1977;21:362-369.
37. Dahlgren J, Anderson E, Hewitt W. Gentamicin blood levels: a guide to nephrotoxicity. Antimicrob Agents Chemother. 1975;8:58-62.
38. Schentag J, Plaut M, Cerra F. Comparative nephrotoxicity of gentamicin and tobramycin: pharmacokinetic and clinical studies in 201 patients. Antimicrob Agents Chemother. 1981;19:859-866.
39. Logsden B. Gentamicin 3 mg/kg dosing and monitoring within the first 7 days of life. J Pediatr Pharm Pract. 1999;4:77-79.
40. Langlass T, Mickle T. Standard gentamicin dosage regimen in neonates. Am J Health Syst Pharm. 1999;56:440-443.
41. Strickland M, Kirkpatrick C, Begg E, et al. An extended interval dosing method for gentamicin in neonates. J Antimicrob Chemother. 2001;48:887-893.
42. Vervelde M, Rademaker C, Krediet T, et al. Population pharmacokinetics of gentamicin in preterm neonates: evaluation of a once-daily dosage regimen. Ther Drug Monit. 1999;21:514-519.
43. Chotigeat U, Narongsanti A, Ayudhya D. Gentamicin in neonatal infection: once versus twice daily dosage. J Med Assoc Thai. 2001;84:1109-1115.
44. Moore R, Lietman P, Smith C. Clinical response to aminoglycoside therapy: importance of the ratio of peak concentration to minimal inhibitory concentration. J Infect Dis. 1987;155:93-99.
45. Moore R, Smith C, Lietman P. Association of aminoglycoside plasma levels with therapeutic outcome in gram-negative pneumonia. Am J Med. 1984;77:657-662.
46. Moore R, Smith C, Lietman P. Association of aminoglycoside plasma levels with mortality in patients with gram-negative bacteremia. J Infect Dis. 1984;149:443-448.
47. de Hoog M, van Zanten B, Hop W, et al. Newborn hearing screening: tobramycin and vancomycin are not risk factors for hearing loss. J Pediatr. 2003;142:41-46.
48. Bradley JS, Nelson JD. Nelson's Pocket Book of Pediatric Antimicrobial Therapy. 16th ed. Buenos Aires, Argentina: Alliance for World Wide Editing; 2006.
49. Tsu V, Sutanto A, Vaidya K, et al. Oxytocin in prefilled Uniject devices for managing third-stage labor in Indonesia. Int J Gynaecol Obstet. 2003;83:103-111.
50. Quiroga R, Halkyer P, Gil F, et al. A prefilled injection device for outreach tetanus immunization by Bolivian traditional birth attendants. Rev Panam Salud Publica. 1998;4:20-25.
51. Sutanto A, Suarnawa I, Nelson C, et al. Home delivery of heat-stable vaccines in Indonesia: outreach immunization with a prefilled, single-use injection device. Bull World Health Organ. 1999;77:119-126.
52. Otto B, Suarnawa I, Stewart T, et al. At-birth immunization against hepatitis B using a novel pre-filled immunization device stored outside the cold chain. Vaccine. 2000;18:498-502.