- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00711763
Calciuric Effect and Cyclic Parenteral Nutrition in Preterm Infants
The aim of our work is to study the effect of total parenteral nutrition (TPN) cycling in preterm infants on hypercalcuria (excessive calcium excretion in urine). TPN cycling refers to administering the TPN over a portion of the day rather than the whole day. Our hypothesis is that cyclic TPN includes more hypercalcuria in preterm infants as compared to continuous TPN.
Objectives:
Measure Urinary Calcium(Ca) during the periods of continuous and cyclic TPN.
Compare the amount of Ca losses in the urine continuous vs. cyclic TPN
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Louisiana
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Shreveport, Louisiana, United States, 71130
- Louisiana State University Health Science Center-Shreveport
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Preterm babies with birth weights of 1500 gm or less.
- Expected to be restricted from oral feeding or on trophic feeds
- On TPN for at least 6 days
Exclusion Criteria:
- Infants who at the time of enrollment are on any diuretics (Lasix, hydrochlorothiazide, Aldactone, etc.) or caffeine
- those who are hemodynamically unstable
- Or have renal or hepatic insufficiency
- Infants with major congenital anomalies
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Collaborators and Investigators
Investigators
- Principal Investigator: Sameh Hussein, M.D., Louisiana State University Health Science Center-Shreveport
Publications and helpful links
General Publications
- Hurley DL, McMahon MM. Long-term parenteral nutrition and metabolic bone disease. Endocrinol Metab Clin North Am. 1990 Mar;19(1):113-31.
- Koo WW, Tsang RC, Succop P, Krug-Wispe SK, Babcock D, Oestreich AE. Minimal vitamin D and high calcium and phosphorus needs of preterm infants receiving parenteral nutrition. J Pediatr Gastroenterol Nutr. 1989 Feb;8(2):225-33. doi: 10.1097/00005176-198902000-00017.
- Koo WW, Sherman R, Succop P, Krug-Wispe S, Tsang RC, Steichen JJ, Crawford AH, Oestreich AE. Fractures and rickets in very low birth weight infants: conservative management and outcome. J Pediatr Orthop. 1989 May-Jun;9(3):326-30.
- Ferrone M, Geraci M. A review of the relationship between parenteral nutrition and metabolic bone disease. Nutr Clin Pract. 2007 Jun;22(3):329-39. doi: 10.1177/0115426507022003329.
- Shike M, Harrison JE, Sturtridge WC, Tam CS, Bobechko PE, Jones G, Murray TM, Jeejeebhoy KN. Metabolic bone disease in patients receiving long-term total parenteral nutrition. Ann Intern Med. 1980 Mar;92(3):343-50. doi: 10.7326/0003-4819-92-3-343.
- Shike M, Shils ME, Heller A, Alcock N, Vigorita V, Brockman R, Holick MF, Lane J, Flombaum C. Bone disease in prolonged parenteral nutrition: osteopenia without mineralization defect. Am J Clin Nutr. 1986 Jul;44(1):89-98. doi: 10.1093/ajcn/44.1.89.
- Klein GL, Targoff CM, Ament ME, Sherrard DJ, Bluestone R, Young JH, Norman AW, Coburn JW. Bone disease associated with total parenteral nutrition. Lancet. 1980 Nov 15;2(8203):1041-4. doi: 10.1016/s0140-6736(80)92271-0.
- Aladangady N, Coen PG, White MP, Rae MD, Beattie TJ. Urinary excretion of calcium and phosphate in preterm infants. Pediatr Nephrol. 2004 Nov;19(11):1225-31. doi: 10.1007/s00467-004-1574-1.
- Atkinson SA, Shah JK, McGee C, Steele BT. Mineral excretion in premature infants receiving various diuretic therapies. J Pediatr. 1988 Sep;113(3):540-5. doi: 10.1016/s0022-3476(88)80648-6.
- Pelegano JF, Rowe JC, Carey DE, LaBarre DJ, Edgren KW, Lazar AM, Horak E. Effect of calcium/phosphorus ratio on mineral retention in parenterally fed premature infants. J Pediatr Gastroenterol Nutr. 1991 Apr;12(3):351-5. doi: 10.1097/00005176-199104000-00011.
- Linkswiler HM, Zemel MB, Hegsted M, Schuette S. Protein-induced hypercalciuria. Fed Proc. 1981 Jul;40(9):2429-33.
- Wood RJ, Bengoa JM, Sitrin MD, Rosenberg IH. Calciuretic effect of cyclic versus continuous total parenteral nutrition. Am J Clin Nutr. 1985 Mar;41(3):614-9. doi: 10.1093/ajcn/41.3.614.
- Btaiche IF, Khalidi N. Parenteral nutrition-associated liver complications in children. Pharmacotherapy. 2002 Feb;22(2):188-211. doi: 10.1592/phco.22.3.188.33553.
- Collier S, Crough J, Hendricks K, Caballero B. Use of cyclic parenteral nutrition in infants less than 6 months of age. Nutr Clin Pract. 1994 Apr;9(2):65-8. doi: 10.1177/011542659400900265.
- Takehara H, Hino M, Kameoka K, Komi N. A new method of total parenteral nutrition for surgical neonates: it is possible that cyclic TPN prevents intrahepatic cholestasis. Tokushima J Exp Med. 1990 Dec;37(3-4):97-102.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H08-048
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