NCT00711763

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

2.8 years

First QC Date

July 3, 2008

Last Update Submit

July 21, 2020

Conditions

Preterm InfantsMetabolic Bone Disease

Keywords

Preterm InfantParenteral nutrition cyclingTPN cyclingHypercalcuria

Eligibility Criteria

Age1 Hour - 9 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patients will be recruited from the NICU at (LSUHSC) after obtaining parental consent.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louisiana State University Health Science Center-Shreveport

Shreveport, Louisiana, 71130, United States

Location

Related Publications (15)

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

    PMID: 2113469BACKGROUND

  • 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.

    PMID: 2496213BACKGROUND

  • 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.

    PMID: 2723052BACKGROUND

  • 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.

    PMID: 17507733BACKGROUND

  • 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.

    PMID: 6766694BACKGROUND

  • 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.

    PMID: 3088971BACKGROUND

  • 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.

    PMID: 6107676BACKGROUND

  • 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.

    PMID: 15349762BACKGROUND

  • 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.

    PMID: 3411401BACKGROUND

  • 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.

    PMID: 1649288BACKGROUND

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

    PMID: 7250387BACKGROUND

  • 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.

    PMID: 3919560BACKGROUND

  • 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.

    PMID: 11837558BACKGROUND

  • 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.

    PMID: 8078440BACKGROUND

  • 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.

    PMID: 2128784BACKGROUND

MeSH Terms

Conditions

Bone Diseases, MetabolicPremature BirthHypercalciuria

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sameh Hussein, M.D.

    Louisiana State University Health Science Center-Shreveport

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2008

First Posted

July 9, 2008

Study Start

July 1, 2008

Primary Completion

April 1, 2011

Study Completion

September 1, 2011

Last Updated

July 23, 2020

Record last verified: 2020-07

Locations

US(1)