NCT00290160

Brief Summary

Evaluate if early protein supplementation decreases the incidence of hyperkalemia in Extremely Low Birth Weight Infants (babies less than 1,000 grams birth weight).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

2.8 years

First QC Date

February 8, 2006

Last Update Submit

October 2, 2023

Conditions

Hyperkalemia

Keywords

HyperkalemiaProteinHyperglycemiaELBW

Outcome Measures

Primary Outcomes (1)

  • Incidence of hyperkalemia in between groups

Secondary Outcomes (1)

  • Incidence of hyperglycemia, post-natal growth, neurodevelopmental outcome at 18 months

Interventions

Protein supplementationBEHAVIORAL

Eligibility Criteria

Age1 Minute - 12 Hours
Sexall
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health System

San Antonio, Texas, 78229, United States

Location

Related Publications (3)

  • Blanco CL, Gong AK, Schoolfield J, Green BK, Daniels W, Liechty EA, Ramamurthy R. Impact of early and high amino acid supplementation on ELBW infants at 2 years. J Pediatr Gastroenterol Nutr. 2012 May;54(5):601-7. doi: 10.1097/MPG.0b013e31824887a0.

    PMID: 22228000DERIVED

  • Blanco CL, Gong AK, Green BK, Falck A, Schoolfield J, Liechty EA. Early changes in plasma amino acid concentrations during aggressive nutritional therapy in extremely low birth weight infants. J Pediatr. 2011 Apr;158(4):543-548.e1. doi: 10.1016/j.jpeds.2010.09.082. Epub 2010 Dec 3.

    PMID: 21129755DERIVED

  • Blanco CL, Falck A, Green BK, Cornell JE, Gong AK. Metabolic responses to early and high protein supplementation in a randomized trial evaluating the prevention of hyperkalemia in extremely low birth weight infants. J Pediatr. 2008 Oct;153(4):535-40. doi: 10.1016/j.jpeds.2008.04.059. Epub 2008 Jun 27.

    PMID: 18589451DERIVED

MeSH Terms

Conditions

HyperkalemiaHyperglycemia

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Study Officials

  • Cynthia L Blanco, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2006

First Posted

February 10, 2006

Study Start

December 1, 2002

Primary Completion

September 1, 2005

Study Completion

July 1, 2007

Last Updated

October 5, 2023

Record last verified: 2023-10

Locations

US(1)