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| ID | Type | Description | Link |
|---|---|---|---|
| U10HD021364 | U.S. NIH Grant/Contract | View source | |
| U10HD021415 | U.S. NIH Grant/Contract | View source | |
| U01HD019897 | U.S. NIH Grant/Contract | View source | |
| U10HD021385 | U.S. NIH Grant/Contract | View source | |
| U10HD021397 | U.S. NIH Grant/Contract | View source | |
| U10HD021373 | U.S. NIH Grant/Contract | View source |
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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 control group. There were two phases to the study (see below). During phase 1 the control infants received infusions of placebo. During phase 2 the control infants received no infusion therapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immune globulin | Active Comparator | Lyophilized human immune globulin product |
|
| Albumin solution | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVIG | Drug | The infants received their first dose of study drug within 24 hours of randomization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of nosocomial infection | Including septicemia, meningitis, or urinary tract infection | 120 days of life |
| Measure | Description | Time Frame |
|---|---|---|
| Death | 120 Days of life | |
| Morbidity | Duration of ventilator support, frequency of bronchopulmonary dysplasia, and duration of hospitalization | 120 days of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Avroy A. Fanaroff, MD | Case Western Reserve University | Study Director |
| Sheldon B. Korones, MD | University of Tennessee | Principal Investigator |
| Elizabeth C. Wright, PhD | George Washington University | Principal Investigator |
| Ronald L. Poland, MD | Wayne State University | Principal Investigator |
| Charles R. Bauer, MD | University of Miami | Principal Investigator |
| Jon E. Tyson, MD MPH | University of Texas | Principal Investigator |
| Joseph B. Philips, MD | University of Alabama at Birmingham | Principal Investigator |
| Jerold F. Lucey, MD | University of Vermont, Burlington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| George Washington University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9686724 | Result | 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. | |
| 8133853 | Result |
| Label | URL |
|---|---|
| NICHD Neonatal Research Network | View source |
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| Placebo | Drug | An equal volume of 5 percent albumin solution |
|
| Local infections | 120 days of life |
| Necrotizing enterocolitis | 120 days of life |
| Specific complications of immune globulin or placebo infusion | 120 days of life |
| Washington D.C. |
| District of Columbia |
| 20052 |
| United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | United States |
| University of Tennessee | Memphis | Tennessee | 38163 | United States |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | United States |
| University of Vermont | Burlington | Vermont | 05405 | United States |
| 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. |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D018805 | Sepsis |
| D008581 | Meningitis |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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