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Calciuric Effect and Cyclic Parenteral Nutrition in Preterm Infants

Louisiana State University Health Sciences Center Shreveport logo

Louisiana State University Health Sciences Center Shreveport

Status

Terminated

Conditions

Metabolic Bone Disease
Preterm Infants

Study type

Observational

Funder types

Other

Identifiers

NCT00711763
H08-048

Details and patient eligibility

About

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

Full 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.

Enrollment

1 patient

Sex

All

Ages

1 hour to 9 months old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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