- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01203345
Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection (IVIG)
Randomized Clinical Trial of Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection in Very-Low-Birth-Weight Infants
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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 exposure to resistant organisms and multiple invasive procedures, in the presence of immunologic immaturity, renders these infants vulnerable to hospital-acquired infections. Prior studies testing the ability of intravenous immune globulin to prevent nosocomial infections in premature infants have varied in design and sample size. Despite differences in the rates of observed infection, immune globulin preparations, doses, and infusion intervals, a meta-analysis of published reports suggests that nosocomial infections may be diminished by the prophylactic infusion of IgG.
The National Institute of Child Health and Human Development (NICHD) Neonatal Research Network therefore performed a prospective, multicenter, randomized trial at eight participating centers to test the hypothesis that the intravenous administration of immune globulin to infants with birth weights between 501 and 1500g would reduce the incidence of nosocomial infections.
Patients were randomly assigned to an intravenous immune globulin group or a control group. During phase 1 the control infants received infusions of placebo. During phase 2 the control infants received no infusion therapy.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35233
- University of Alabama at Birmingham
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20052
- George Washington University
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Florida
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Miami, Florida, Forenede Stater, 33136
- University of Miami
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Michigan
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Detroit, Michigan, Forenede Stater, 48201
- Wayne State University
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- Case Western Reserve University, Rainbow Babies and Children's Hospital
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38163
- University of Tennessee
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Texas
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Dallas, Texas, Forenede Stater, 75235
- University of Texas Southwestern Medical Center at Dallas
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Vermont
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Burlington, Vermont, Forenede Stater, 05405
- University of Vermont
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- All neonates with birth weights of 501 to 1500 g
Exclusion Criteria:
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Immune globulin
Lyophilized human immune globulin product
|
The infants received their first dose of study drug within 24 hours of randomization.
Andre navne:
|
Placebo komparator: Albumin solution
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An equal volume of 5 percent albumin solution
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Incidence of nosocomial infection
Tidsramme: 120 days of life
|
Including septicemia, meningitis, or urinary tract infection
|
120 days of life
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Death
Tidsramme: 120 Days of life
|
120 Days of life
|
|
Morbidity
Tidsramme: 120 days of life
|
Duration of ventilator support, frequency of bronchopulmonary dysplasia, and duration of hospitalization
|
120 days of life
|
Local infections
Tidsramme: 120 days of life
|
120 days of life
|
|
Necrotizing enterocolitis
Tidsramme: 120 days of life
|
120 days of life
|
|
Specific complications of immune globulin or placebo infusion
Tidsramme: 120 days of life
|
120 days of life
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Avroy A. Fanaroff, MD, Case Western Reserve University
- Ledende efterforsker: Ronald L. Poland, MD, Wayne State University
- Ledende efterforsker: Joseph B. Philips, MD, University of Alabama at Birmingham
- Ledende efterforsker: Jerold F. Lucey, MD, University of Vermont, Burlington
Publikationer og nyttige links
Generelle publikationer
- Fanaroff AA, Korones SB, Wright LL, Verter J, Poland RL, Bauer CR, Tyson JE, Philips JB 3rd, Edwards W, Lucey JF, Catz CS, Shankaran S, Oh W. Incidence, presenting features, risk factors and significance of late onset septicemia in very low birth weight infants. The National Institute of Child Health and Human Development Neonatal Research Network. Pediatr Infect Dis J. 1998 Jul;17(7):593-8. doi: 10.1097/00006454-199807000-00004.
- Fanaroff AA, Korones SB, Wright LL, Wright EC, Poland RL, Bauer CB, Tyson JE, Philips JB 3rd, Edwards W, Lucey JF, et al. A controlled trial of intravenous immune globulin to reduce nosocomial infections in very-low-birth-weight infants. National Institute of Child Health and Human Development Neonatal Research Network. N Engl J Med. 1994 Apr 21;330(16):1107-13. doi: 10.1056/NEJM199404213301602.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NICHD-NRN-0002
- U10HD021364 (U.S. NIH-bevilling/kontrakt)
- U10HD021373 (U.S. NIH-bevilling/kontrakt)
- U10HD021385 (U.S. NIH-bevilling/kontrakt)
- U01HD019897 (U.S. NIH-bevilling/kontrakt)
- U10HD021415 (U.S. NIH-bevilling/kontrakt)
- U10HD021397 (U.S. NIH-bevilling/kontrakt)
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