Clinical trial NCT00711763: Calciuric Effect and Cyclic Parenteral Nutrition in Preterm Infants
Official title: Calciuric Effect and Cyclic Parenteral Nutrition in Preterm Infants
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Preterm Infants
Metabolic Bone Disease
Keywords: Preterm Infant
Parenteral nutrition cycling
TPN cycling
Hypercalcuria
Lead sponsor: Louisiana State University Health Sciences Center Shreveport
Sponsor class: OTHER
First posted: 2008-07-09
Enrollment: 1
Sex: ALL
Minimum age (years): 1
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited from the NICU at (LSUHSC) after obtaining parental consent.

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: Louisiana State University Health Science Center-Shreveport
state: Louisiana
Study officials:
affiliation: Louisiana State University Health Science Center-Shreveport
name: Sameh Hussein, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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