NCT00702767

Brief Summary

This study was completed in October 2006. No further participates are being recruited.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2005

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

July 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2008

Completed
Last Updated

June 24, 2008

Status Verified

June 1, 2008

Enrollment Period

1.3 years

First QC Date

June 19, 2008

Last Update Submit

June 23, 2008

Conditions

Low Birth Weight

Keywords

This study was completed in October 2006

Interventions

INTRALIPIDSDRUG

INTRAVENOUS FAT EMULSIONS

Eligibility Criteria

AgeUp to 1 Day
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All infants who are Appropriate for Gestational Age at Birth and who have a birthweight between 750-1500 grams will be enrolled in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Drenckpohl D, McConnell C, Gaffney S, Niehaus M, Macwan KS. Randomized trial of very low birth weight infants receiving higher rates of infusion of intravenous fat emulsions during the first week of life. Pediatrics. 2008 Oct;122(4):743-51. doi: 10.1542/peds.2007-2282.

    PMID: 18829797DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2008

First Posted

June 20, 2008

Study Start

July 1, 2005

Primary Completion

October 1, 2006

Study Completion

April 1, 2007

Last Updated

June 24, 2008

Record last verified: 2008-06