Newborns and drug studies: The NICHD/FDA newborn drug development initiative

Clinical Therapeutics

Volumn 27, Issue 6, 2005, Pages 796-813

  Giacoia, George P ^a,b   Mattison, Donald R ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

^b EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

Author keywords

National Institute of Child Health and Human Development; NDDI; Neonate; US Food and Drug Administration

Indexed keywords

ACICLOVIR; AMFEBUTAMONE; AZITHROMYCIN; BACLOFEN; BENZOIC ACID; BENZYL ALCOHOL; BUMETANIDE; CHLORAMPHENICOL; CLONIDINE; CYCLOSPORIN; DACTINOMYCIN; DOBUTAMINE; DOPAMINE; ERYTHROMYCIN; FLECAINIDE; FUROSEMIDE; HYDROCHLOROTHIAZIDE; INOTROPIC AGENT; LINDANE; LITHIUM; LORAZEPAM; MACROGOL; METOLAZONE; MIDAZOLAM; NITROPRUSSIDE SODIUM; PROPYLENE GLYCOL; SPIRONOLACTONE; TOLAZOLINE; UNINDEXED DRUG; VINCRISTINE;

ATTENTION DEFICIT DISORDER; AUTISM; BACTERIAL PNEUMONIA; CANCER; CARDIOVASCULAR DISEASE; CARDIOVASCULAR MALFORMATION; CEREBRAL PALSY; CHLAMYDIASIS; CLINICAL TRIAL; COMA; CONFERENCE PAPER; CONJUNCTIVITIS; DEPRESSION; DRUG EFFECT; DRUG EFFICACY; DRUG FORMULATION; DRUG HALF LIFE; DRUG POTENTIATION; DRUG RESEARCH; DRUG SAFETY; DUODENUM PERFORATION; EPILEPTIC STATE; GASTROESOPHAGEAL REFLUX; GASTROINTESTINAL HEMORRHAGE; GRAFT REJECTION; HEART FAILURE; HEART VENTRICLE ARRHYTHMIA; HUMAN; HYPEROSMOLALITY; HYPERTENSION; HYPOXEMIA; INFECTION; ISCHEMIA; LUNG DYSPLASIA; MANIA; NEPHROTOXICITY; NEWBORN; NEWBORN DISEASE; PULMONARY HYPERTENSION; SCABIES; SEDATION; SEPSIS; SIDE EFFECT; SPASTICITY;

EID: 27744574703     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2005.06.008     Document Type: Conference Paper

References (69)

1. Shirkey HC. Speech presented at: Conference of Professional and Scientific Societies, Commission on Drug Safety; June 27-28, 1963; Chicago, III.
2. Giacoia GP. Incentive to study drugs in children and other governmental initiatives: Will patients with asthma benefit? J Allergy Clin Immunol. 2000;106(Suppl):S118-S124.
3. Best Pharmaceutical for Children Act, 21 USC §355b, 393a (2003).
4. Pediatric Research Equity, Pub L No. 108-155, 117 Stat 1936 (2003).
5. O'Donnell CP, Stone RJ, Morely CJ. Unlicensed and off-label drug use in an Australian neonatal intensive care unit. Pediatrics. 2002;110:e52.
6. Lesko SM, Epstein MF, Mitchell AA. Recent patterns of drug use in newborn intensive care. J Pediatr. 1990;116:985-990.
7. Mitchell AA, Goldman P, Shapiro S, Slone D. Drug utilization and reported adverse reactions in hospitalized children. Am J Epidemiol. 1979;110:196-204.
8. Kumar SP. Adverse drug reactions in the newborn. Ann Clin Lab Sci. 1985;15:195-203.
9. McClean P, Weaver LT. Ontogeny of human pancreatic exocrine function. Arch Dis Chid. 1993;68:62-65.
10. Lebenthal E, Lee PC. Development of functional responses in human exocrine pancreas. Pediatrics. 1980;66:556-560.
11. Arant BS Jr. Developmental patterns of renal functional maturation compared in the human neonate. J Pediatr. 1978;92:705-712.
12. Euler AR, Byrne WJ, Cousins LM, et al. Increased serum gastrin concentrations and gastric acid hyposecretion in the immediate newborn period. Gastmenterology. 1977;72: 1271-1273.
13. Avery GB, Randolph JG, Weaver T. Gastric acidity in the first day of life. Pediatrics. 1966;37:1005-1007.
14. Berseth CL. Gestational evolution of small intestine motility in preterm and term infants. J Pediatr. 1989; 115:646-651.
15. Ittmann PI, Amamath R, Berseth CL. Maturation of antroduodenal motor activity in preterm and term infants. Dig Dis Sci. 1992:37:14-19.
16. Boehm G, Braun W, Moro G, Minoli I. Bile acid concentrations in serum and duodenal aspirates of healthy preterm infants: Effects of gestational age and postnatal age. Biol Neonate. 1997;71:207-214.
17. Huang NN, High RH. Comparison of serum levels following the administration of oral and parenteral preparations of penicillin to infants and children of various age groups. J Pediatr. 1953;42:657-658.
18. Silverio J, Poole JW. Serum concentrations of ampicillin in newborn infants after oral administration. Pediatrics. 1973;51:578-580.
19. Radde IC. Mechanisms of drug absorption and their development. In: MacLeod SM, Radde IC, eds. Textbook of Pediatric Clinical Pharmacology. Littleton, Mass: PSG Publishing; 1985:17-43.
20. Widdowson EM. Growth and composition of the fetus and newborn. In: Assali NS, ed. Biology of Gestation. vol 2. New York: Academic Press; 1968:1-49.
21. Ehmebo M, Agurell S, Jalling B, Boreus LO. Age differences in drug binding by plasma proteins: Studies on human fetuses, neonates and adults. Eur Clin Pharmacol. 1971;3: 189-193.
22. Blake MJ, Castro L, Leeder JS, Kearns GL. Ontogeny of drug metabolizing enzymes in the neonate. Semin Fetal Neonatal Med. 2005;10: 123-138.
23. Richard K, Hume R, Kaptein E, et al. Sulfation of thyroid hormone and dopamine during human development: Ontogeny of phenol sulfotransferases and arylsulfatase in liver, lung, and brain. J Clin Endocrinol Metab. 2001;86:2734-2742.
24. Pacific GM, Franchi M, Giuliani L, Rane A. Development of the glucuronyltransferase and sulphotransferase towards 2-naphthol in human fetus. Dev Pharmacol Ther. 1989;14:108-114.
25. Pons G, Rey E, Carrier O, et al. Maturation of AFMU excretion in infants. Fundam Clin Pharmacol. 1989;3:589-595.
26. Mahmood B, Daood MJ, Heart C, et al. Ontogeny of P-glycoprotein in mouse intestine, liver, and kidney. J Investig Med. 2001;49:250-257.
27. Van den Anker JN, Schoemaker RC, Hop WC, et al. Ceftazidime pharmacokinetics in preterm infants: Effects of renal function and gestational age. Clin Pharmacol Ther. 1995; 58:650-659.
28. Van den Anker JN, Hop WC, de Groot R, et al. Effects of prenatal exposure to betamethasone and indomethacin on the glomerular filtration rate in the preterm infant. Pediatr Res. 1994;36:578-581.
29. Takahashi H, Ishikawa S, Nomoto S, et al. Developmental changes in pharmacokinetics and pharmacodynamics of warfarin enantiomers in Japanese children. Clin Pharmacol Ther. 2000; 68:541-555.
30. Marshall JD, Kearns GL. Developmental pharmacodynamics of cyclosporine. Clin Pharmacol Ther. 1999; 66:66-75.
31. Andersen DL, Eckert AL, Tsai VW, et al. GABA(A) receptor sites in the developing human foetus. Brain Res Dev Brain Res. 2002;139:107-119.
32. Cotton EK. The use of priscoline in the treatment of the hypoperfusion syndrome. Pediatrics. 1965;36:149. Letter.
33. Goetzman BW, Sunshine P, Johnson JD, et al. Neonatal hypoxia and pulmonary vasospasm: Response to tolazoline. J Pediatr. 1976;89:617-621.
34. Stevens DC, Schreiner RL, Bull MJ, et al. An analysis of tolazoline therapy in the critically-ill neonate. J Pediatr Surg. 1980;15:964-970.
35. Stevenson DK, Kasting DS, Damall RA Jr, et al. Refractory hypoxemia associated with neonatal pulmonary disease: The use and limitations of tolazoline. J Pediatr. 1979;95:595-599.
36. Korones SB, Eyal FG. Successful treatment of persistent fetal circulation with tolazline. Pediatr Res. 1975; 9:367. Abstract.
37. Monin P, Vert P, Morselli PL. A pharmacodynamic and pharmacokinetic study of tolazline in the neonate. Dev Pharmacol Ther. 1982;4 (Suppl):124-128.
38. Ward RM, Daniel CH, Kendig JW, Wood MA. Oliguria and tolazoline pharmacokinetics in the newborn. Pediatrics. 1986;77:307-315.
39. Ward RM. Pharmacology of tolazoline. Clin Perinatol. 1984;11:703-713.
40. Dillard RG. Fatal gastrointestinal hemorrhage in a neonate treated with tolazoline. Clin Pediatr (Phila). 1982;21:761-762.
41. Wilson RG, George RJ, McCormick WJ, Raine PA. Duodenal perforation associated with tolazoline. Arch Dis Child. 1985;60:878-879.
42. Konduri GG. New approaches for persistent pulmonary hypertension of newborn. Clin Perinatol. 2004;31:591-611.
43. Giacoia G, Birenbaum DL, Sachs HC, et al. The Newborn Drug Development Initiative. Pediatrics. In press.
44. Menon PA, Thach BT, Smith CH, et al. Benzyl alcohol toxicity in a neonatal intensive care unit. Incidence, symptomatology, and mortality. Am J Perinatol. 1984;1:288-292.
45. Weiss CF, Glazko AJ, Weston JK. Chloramphenicol in the newborn infant. A physiologic explanation of its toxicity when given in excessive doses. N Engl J Med. 1960;262:787-794.
46. de Wildt SN, de Hoog M, Vinks AA, et al. Population pharmacokinetics and metabolism of midazolam in pediatric intensive care patients. Crit Care Med. 2003;31:1952-1958.
47. Giacoia GP. Adverse drug effects and adverse drug reactions in pediatric patients: Workshop summary and recommendations. Curr Ther Res Clin Exp. 2001;62:942-950.
48. Nahata MC. Drug formulations. In: Yaffe SJ, Aranda JV, eds. Neonatal and Pediatrie Pharmacology: Therapeutic Principles in Practice. 3rd ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2004:111-118.
49. Horn LW, Kuhn RJ, Kanga SJ. Evaluation of the reproducibility of tablet splitting to provide accurate doses for the pediatric population. J Pediatr Pharm Pract. 1999;4:38-42.
50. Maone TR, Mattes RD, Berbaum JC, Beauchamp GK. A new method for delivering a taste without fluids to preterm and term infants. Dev Psychobiol. 1990;23:179-191.
51. Rosenstein D, Oster H. Differential facial responses to four basic tastes in newborns. Child Dev. 1988;59: 1555-1568.
52. Glasgow AM, Boeckx RL, Miller MK. Hyperosmolality in small infants due to propylene glycol. Pediatrics. 1983;72:353-355.
53. Murch S, Costeloe K. Hyperosmolality related to propylene glycol in an infant. BMJ. 1990;301:389.
54. Fligner CL, Jack R, Twiggs GA, Raisys VA. Hyperosmolality induced by propylene glycol. A complication of silver sulfadiazine therapy. JAMA. 1985;253:1606-1609.
55. Peleg O, Bar-Oz B, Arad I. Coma in a premature infant associated with the transdermal absorption of propylene glycol. Acta Paediatr. 1998; 87:1195-1196.
56. Gershanik J, Boecler B, Ensley H, et al. The gasping syndrome and benzyl alcohol poisoning. N Engl J Med. 1982;307:1384-1388.
57. Lopez-Herce J, Bonet C, Meana A, Albajara L. Benzyl alcohol poisoning following diazepam intravenous infusion. Ann Pharmacother. 1995;29: 632.
58. Brown WJ, Buist NR, Gipson HT, et al. Fatal benzyl alcohol poisoning in a neonatal intensive care unit. Lancet. 1982;1:1250.
59. Anderson CW, Ng KJ, Andresen B, Cordero L. Benzyl alcohol poisoning in a premature newborn infant. Am J Obstet Gynecol. 1984;148:344-346.
60. 68 Federal Register 2789-2790 (2003).
61. 68 Federal Register 48402-48404 (2003).
62. 69 Federal Register 7243-7244 (2004).
63. 70 Federal Register 3937-3940 (2005).
64. Soler C, Figueras J, Roca I, et al. Pulmonary perfusion scientigraphy in the evaluation of the severity of bronchopulmonary dysplasia. Pediatr Rediol. 1997;27:32-35.
65. Marx CM,Smith PG,Lowrie LH, et al. Optimal sedation of mechanically ventilated pediatric critical care patients. Crit Care Med. 1994;22:163-170.
66. Poets CF. Gastroesophageal reflux: A critical review of its role in preterm infants, Pediatrics. 2004;113:E128-E132.
67. Sifrim D, Castell D, Dent J, Kahrilas PJ. Gastro-oesophageal reflux monitoring: Review and consensus report on detection and definitions of acid, non-acid, and gas reflux. Gut. 2004; 53:1024-1031.
68. Peter CS, Sprodowski N, Ahlborn V, et al. Inter- and intraobserver agreement for gastroesophageal reflux detection in infants using multiple intraluminal impedance. Biol Neonate. 2004;85:11-14.
69. Braden B, Peterknecht A, Piepho T, et al. Measuring gastric emptying of semisolids in children using 13C-acetate breath test: A validation study. Dig Liver Dis. 2004;36:260-264