Calciuric Effect and Cyclic Parenteral Nutrition in Preterm Infants

Preterm Infants Clinical Trial

Official title:

Calciuric Effect and Cyclic Parenteral Nutrition in Preterm Infants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00711763
• Other study ID #: H08-048
• Status: Terminated
• Start date: July 2008
• Est. completion date: September 2011

Study information

• Verified date: July 2020
• Source: Louisiana State University Health Sciences Center Shreveport
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

Randomized cross over design, in which babies will receive TPN either continuously or on a cyclic basis for 3 days. The patients will then be crossed over to receive the other way of administration over the following 3 days, thus each patient will serve as his or her own control. Continuous TPN will be administered over 24 hours for 3 days, while the cyclic TPN will be given for 18 hours then followed by a Dextrose only solution at the same concentration and rate as the TPN for 6 hours. Trophic feeds up to 20 ml/kg/day will be allowed throughout the study period at the discretion of the attending neonatologist.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 9 Months

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Metabolic Bone Disease
• Premature Birth
• Preterm Infants

Locations

Country	Name	City	State
United States	Louisiana State University Health Science Center-Shreveport	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center Shreveport

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. — View Citation

Btaiche IF, Khalidi N. Parenteral nutrition-associated liver complications in children. Pharmacotherapy. 2002 Feb;22(2):188-211. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Hurley DL, McMahon MM. Long-term parenteral nutrition and metabolic bone disease. Endocrinol Metab Clin North Am. 1990 Mar;19(1):113-31. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Linkswiler HM, Zemel MB, Hegsted M, Schuette S. Protein-induced hypercalciuria. Fed Proc. 1981 Jul;40(9):2429-33. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references