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Calciuric Effect and Cyclic Parenteral Nutrition in Preterm Infants

Calciuric Effect and Cyclic Parenteral Nutrition in Preterm Infants

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00711763
Enrollment
1
Registered
2008-07-09
Start date
2008-07-31
Completion date
2011-09-30
Last updated
2020-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Bone Disease, Preterm Infants

Keywords

Preterm Infant, Parenteral nutrition cycling, TPN cycling, Hypercalcuria

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.

Interventions

None listed

Sponsors

Louisiana State University Health Sciences Center Shreveport
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Hours to 9 Months
Healthy volunteers
Yes

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026