Status:
COMPLETED
Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection
Lead Sponsor:
NICHD Neonatal Research Network
Conditions:
Infant, Newborn
Infant, Low Birth Weight
Eligibility:
All Genders
Up to 72 years
Phase:
PHASE2
PHASE3
Brief Summary
A controlled clinical trial was conducted at eight participating centers between January 1, 1988, and March 31, 1991. Patients were randomly assigned to an intravenous immune globulin group or a contr...
Detailed Description
Although survival rates for very-low-birth-weight infants (≤ 1.5 kg) continue to increase, nosocomial infections remain a major cause of morbidity and mortality. Prolonged hospitalization with exposur...
Eligibility Criteria
Inclusion
- All neonates with birth weights of 501 to 1500 g
Exclusion
- More than 72 hours old
- One of three or more fetuses from a multiple pregnancy
- Had infections associated with toxoplasma, rubella, cytomegalovirus, and herpes simplex viruses (the TORCH complex)
- Has a major congenital malformation, an identifiable syndrome, or a chromosomal abnormality
- Were considered nonviable
- Parental consent could not be obtained
Key Trial Info
Start Date :
January 1 1988
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 1991
Estimated Enrollment :
2416 Patients enrolled
Trial Details
Trial ID
NCT01203345
Start Date
January 1 1988
End Date
March 1 1991
Last Update
March 22 2019
Active Locations (8)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
George Washington University
Washington D.C., District of Columbia, United States, 20052
3
University of Miami
Miami, Florida, United States, 33136
4
Wayne State University
Detroit, Michigan, United States, 48201