Calciuric Effect and Cyclic Parenteral Nutrition in Preterm Infants

NCT ID: NCT00711763

Last Updated: 2020-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-09-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Preterm Infants Metabolic Bone Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

1 Hour

Maximum Eligible Age

9 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Louisiana State University Health Sciences Center Shreveport

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sameh Hussein, M.D.

Role: PRINCIPAL_INVESTIGATOR

Louisiana State University Health Science Center-Shreveport

Locations

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Louisiana State University Health Science Center-Shreveport

Shreveport, Louisiana, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND
PMID: 2113469 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2496213 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2723052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17507733 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6766694 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3088971 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6107676 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15349762 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3411401 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1649288 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 7250387 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3919560 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11837558 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8078440 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2128784 (View on PubMed)

Other Identifiers

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H08-048

Identifier Type: -

Identifier Source: org_study_id

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