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| ID | Type | Description | Link |
|---|---|---|---|
| U10HD021373 | U.S. NIH Grant/Contract | View source | |
| U10HD027904 | U.S. NIH Grant/Contract | View source | |
| U01HD019897 | U.S. NIH Grant/Contract | View source | |
| U10HD027871 | U.S. NIH Grant/Contract | View source | |
| M01RR006022 | U.S. NIH Grant/Contract | View source | |
| U10HD027851 | U.S. NIH Grant/Contract | View source | |
| U10HD027856 | U.S. NIH Grant/Contract | View source | |
| M01RR000750 | U.S. NIH Grant/Contract | View source | |
| U10HD027880 | U.S. NIH Grant/Contract | View source | |
| M01RR000070 | U.S. NIH Grant/Contract | View source | |
| U10HD021397 | U.S. NIH Grant/Contract | View source | |
| U10HD021415 | U.S. NIH Grant/Contract | View source | |
| U10HD021364 | U.S. NIH Grant/Contract | View source | |
| U10HD027853 | U.S. NIH Grant/Contract | View source | |
| M01RR008084 | U.S. NIH Grant/Contract | View source | |
| U10HD034216 | U.S. NIH Grant/Contract | View source | |
| U10HD021385 | U.S. NIH Grant/Contract | View source | |
| U10HD034167 | U.S. NIH Grant/Contract | View source | |
| U10HD027881 | U.S. NIH Grant/Contract | View source | |
| M01RR000997 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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This multi-site, randomized trial was conducted to determine the safety and effectiveness of a higher dose of vitamin A and determine if this would increase the rate of survival without bronchopulmonary dysplasia (BPD) and reduce the risk of sepsis. Infants with birth weights from 401-1000g and who were on mechanical ventilation or supplemental oxygen at 24-96 hours of age were enrolled. Subjects were randomized to either the Vitamin A or a control group. Infants in the Vitamin A group were given a dose of 5000 IU (0.1 ml) intramuscularly on Mondays, Wednesdays, and Fridays for four weeks. Control infants received a sham procedure rather than placebo injections.
Infants with extremely low birth weights (≤1,000 g) have low plasma and tissue concentrations of vitamin A, and vitamin A deficiency may predispose these infants to chronic lung disease. A meta-analysis of clinical trials of vitamin A supplementation for preterm infants revealed a 17% increase in the rate of survival without chronic lung disease, which approached statistical significance.
This multi-site, randomized trial was conducted to determine the safety and effectiveness of a higher dose of vitamin A than that used in previous trials in extremely-low-birth-weight (ELBW) infants. We hypothesized that vitamin A supplementation would increase the rate of survival without bronchopulmonary dysplasia and reduce the risk of sepsis.
Infants with birth weights from 401-1000g and who received mechanical ventilation or supplemental oxygen at 24-96 hours of age were enrolled. Subjects were randomized to either the vitamin A or a control group. Infants in the Vitamin A group were given a dose of 5000 IU (0.1 ml) intramuscularly on Mondays, Wednesdays, and Fridays for four weeks. Control infants received a sham procedure rather than placebo injections.
Serum vitamin A was measured in a central laboratory at base line and at 28 days in the first 300 infants. On study day 28 (two to three days after the last treatment and immediately after a blood sample was collected), the relative dose-response was evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Vitamin A group. |
|
| Control | Sham Comparator | Sham procedure Control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin A | Drug | 5,000 IU (0.1 ml) was given on Mondays, Wednesdays, and Fridays for four weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chronic lung disease or death | Chronic lung disease was defined as the need for oxygen at 36 weeks' postmenstrual age. | 36 weeks' postmenstrual age |
| Measure | Description | Time Frame |
|---|---|---|
| Sepsis | Sepsis was defined on the basis of a positive blood culture and treatment with antibiotics for at least five days (unless the infant died within five days). | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon E. Tyson, MD MPH | University of Texas Southwestern Medical Center | Study Director |
| William Oh, MD | Brown University, Women and Infants Hospital | Principal Investigator |
| Joel Verter, PhD | George Washington University Biostatistics Center | Principal Investigator |
| Richard A. Ehrenkranz, MD | Yale University | Principal Investigator |
| Barbara J. Stoll, MD | Emory University | Principal Investigator |
| James A. Lemons, MD | Indiana University | Principal Investigator |
| David K. Stevenson, MD | Stanford University | Principal Investigator |
| Charles R. Bauer, MD | University of Miami | Study Director |
| Sheldon B. Korones, MD | University of Tennessee | Principal Investigator |
| Edward F. Donovan, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States | ||
| Yale University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19798046 | Background | Stark AR, Tyson JE, Hibberd PL. Variation among institutional review boards in evaluating the design of a multicenter randomized trial. J Perinatol. 2010 Mar;30(3):163-9. doi: 10.1038/jp.2009.157. Epub 2009 Oct 1. | |
| 9179535 | Result | Kennedy KA, Stoll BJ, Ehrenkranz RA, Oh W, Wright LL, Stevenson DK, Lemons JA, Sowell A, Mele L, Tyson JE, Verter J. Vitamin A to prevent bronchopulmonary dysplasia in very-low-birth-weight infants: has the dose been too low? The NICHD Neonatal Research Network. Early Hum Dev. 1997 Jul 24;49(1):19-31. doi: 10.1016/s0378-3782(97)01869-0. |
| Label | URL |
|---|---|
| NICHD Neonatal Research Network | View source |
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| Sham Procedure | Other | Control infants received a sham procedure rather than placebo injections. |
|
| Case Western Reserve University |
| Principal Investigator |
| New Haven |
| Connecticut |
| 06504 |
| United States |
| George Washington University | Washington D.C. | District of Columbia | 20052 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Emory University | Atlanta | Georgia | 30303 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Cincinnati Children's Medical Center | Cincinnati | Ohio | 45267 | United States |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | United States |
| Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
| University of Tennessee | Memphis | Tennessee | 38163 | United States |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | United States |
| 10379020 | Result | Tyson JE, Wright LL, Oh W, Kennedy KA, Mele L, Ehrenkranz RA, Stoll BJ, Lemons JA, Stevenson DK, Bauer CR, Korones SB, Fanaroff AA. Vitamin A supplementation for extremely-low-birth-weight infants. National Institute of Child Health and Human Development Neonatal Research Network. N Engl J Med. 1999 Jun 24;340(25):1962-8. doi: 10.1056/NEJM199906243402505. |
| 15713907 | Result | Ambalavanan N, Tyson JE, Kennedy KA, Hansen NI, Vohr BR, Wright LL, Carlo WA; National Institute of Child Health and Human Development Neonatal Research Network. Vitamin A supplementation for extremely low birth weight infants: outcome at 18 to 22 months. Pediatrics. 2005 Mar;115(3):e249-54. doi: 10.1542/peds.2004-1812. Epub 2005 Feb 15. |
| 34004189 | Derived | Rysavy MA, Li L, Tyson JE, Jensen EA, Das A, Ambalavanan N, Laughon MM, Greenberg RG, Patel RM, Pedroza C, Bell EF; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Should Vitamin A Injections to Prevent Bronchopulmonary Dysplasia or Death Be Reserved for High-Risk Infants? Reanalysis of the National Institute of Child Health and Human Development Neonatal Research Network Randomized Trial. J Pediatr. 2021 Sep;236:78-85.e5. doi: 10.1016/j.jpeds.2021.05.022. Epub 2021 May 15. |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001997 | Bronchopulmonary Dysplasia |
| D053120 | Respiratory Aspiration |
| D012127 | Respiratory Distress Syndrome, Newborn |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012128 | Respiratory Distress Syndrome |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D014801 | Vitamin A |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
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