Calciuric Effect and Cyclic Parenteral Nutrition in Preterm Infants

This study has suspended participant recruitment.
(failure to recruit more patients and lack of supporting personnel.)
Sponsor:
Information provided by:
Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier:
NCT00711763
First received: July 3, 2008
Last updated: May 4, 2011
Last verified: April 2011
  Purpose

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


Condition
Preterm Infants
Metabolic Bone Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Calciuric Effect and Cyclic Parenteral Nutrition in Preterm Infants

Resource links provided by NLM:


Further study details as provided by Louisiana State University Health Sciences Center Shreveport:

Estimated Enrollment: 1
Study Start Date: July 2008
Estimated Study Completion Date: September 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   up to 9 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711763

Locations
United States, Louisiana
Louisiana State University Health Science Center-Shreveport
Shreveport, Louisiana, United States, 71130
Sponsors and Collaborators
Louisiana State University Health Sciences Center Shreveport
Investigators
Principal Investigator: Sameh Hussein, M.D. Louisiana State University Health Science Center-Shreveport
  More Information

Publications:

Responsible Party: Sameh Hussein, M.D., Assistant Professor of Pediatrics/Neonatology, Louisiana State University Health Science Center-Shreveport
ClinicalTrials.gov Identifier: NCT00711763     History of Changes
Other Study ID Numbers: H08-048
Study First Received: July 3, 2008
Last Updated: May 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Louisiana State University Health Sciences Center Shreveport:
Preterm Infant
Parenteral nutrition cycling
TPN cycling
Hypercalcuria

Additional relevant MeSH terms:
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014