NCT00000584

Brief Summary

To evaluate the capacity of intravenously administered cytomegalovirus (CMV)-immune globin (CMVIG) to immunize high risk premature infants against CMV infections.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 1983

Longer than P75 for phase_3

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, 1983

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1988

Completed
11.4 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

November 26, 2013

Status Verified

December 1, 2005

First QC Date

October 27, 1999

Last Update Submit

November 25, 2013

Conditions

Blood TransfusionCytomegalovirus Infections

Interventions

immunoglobulinsDRUG

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Neonates at high risk for transfusion-transmitted CMV infection. The neonates were either premature, of low birth weight, or had respiratory distress requiring the presence of an umbilical catheter.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • Snydman DR. Prevention of cytomegalovirus-associated diseases with immunoglobulin. Transplant Proc. 1991 Jun;23(3 Suppl 3):131-5, discussion 135. No abstract available.

    PMID: 1648817BACKGROUND

  • Snydman DR, Werner BG, Meissner HC, Cheeseman SH, Schwab J, Bednarek F, Kennedy JL Jr, Herschel M, Magno A, Levin MJ, et al. Use of cytomegalovirus immunoglobulin in multiply transfused premature neonates. Pediatr Infect Dis J. 1995 Jan;14(1):34-40. doi: 10.1097/00006454-199501000-00007.

    PMID: 7715987BACKGROUND

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Immunoglobulins

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

ImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

July 1, 1983

Study Completion

June 1, 1988

Last Updated

November 26, 2013

Record last verified: 2005-12