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Trial record 52 of 68 for:    tpn

Calciuric Effect and Cyclic Parenteral Nutrition in Preterm Infants

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ClinicalTrials.gov Identifier: NCT00711763
Recruitment Status : Suspended (failure to recruit more patients and lack of supporting personnel.)
First Posted : July 9, 2008
Last Update Posted : May 6, 2011
Sponsor:
Information provided by:
Louisiana State University Health Sciences Center Shreveport

Tracking Information
First Submitted Date July 3, 2008
First Posted Date July 9, 2008
Last Update Posted Date May 6, 2011
Study Start Date July 2008
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00711763 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Calciuric Effect and Cyclic Parenteral Nutrition in Preterm Infants
Official Title Calciuric Effect and Cyclic Parenteral Nutrition in Preterm Infants
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.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients will be recruited from the NICU at (LSUHSC) after obtaining parental consent.
Condition
  • Preterm Infants
  • Metabolic Bone Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: July¬†3,¬†2008)
1
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 9 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00711763
Other Study ID Numbers H08-048
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sameh Hussein, M.D., Assistant Professor of Pediatrics/Neonatology, Louisiana State University Health Science Center-Shreveport
Study Sponsor Louisiana State University Health Sciences Center Shreveport
Collaborators Not Provided
Investigators
Principal Investigator: Sameh Hussein, M.D. Louisiana State University Health Science Center-Shreveport
PRS Account Louisiana State University Health Sciences Center Shreveport
Verification Date April 2011