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| Name | Class |
|---|---|
| The University of Texas Health Science Center, Houston | OTHER |
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The purpose of this study is to determine whether early (before NICU discharge) or late (55-60 weeks post-menstrual age) inguinal hernia repair is safer for premature infants who have an inguinal hernia.
This is a randomized clinical trial comparing early versus late repair in premature infants with an inguinal hernia (IH) to determine which approach may be safer. Safety in this trial is defined as the freedom from significant adverse events, a reduction in hospital days during the study period, and normal neurodevelopmental testing at 2 years. Costs of each treatment strategy are also important and are being evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early inguinal hernia (IH) repair | Active Comparator | IH repair before NICU discharge |
|
| Late inguinal hernia (IH) repair | Active Comparator | IH repair as outpatient at approximately 55-60 weeks post-menstrual age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IH repair before NICU discharge | Procedure | The IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Significant adverse event (SAE) rate | Specific significant adverse events that are either treatment related or hernia related have been defined a priori and will be assessed in both groups from randomization until 9 months after NICU discharge. | 9 months beyond NICU discharge |
| Number of hospital days | Total number of hospital days | From randomization until 9 months post NICU discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital costs | Departmental level costs at each participating institution will be determined for care that occurs from randomization until 9 months post NICU discharge. | Enrollment through 9 months after NICU discharge |
| Bayley Scales of Infant Development, 3rd Edition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin L Blakely, MD, MS | Vanderbilt University Medical Center | Principal Investigator |
| Jon E Tyson, MD, MPH | University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham School of Medicine; Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38530261 | Derived | HIP Trial Investigators; Blakely ML, Krzyzaniak A, Dassinger MS, Pedroza C, Weitkamp JH, Gosain A, Cotten M, Hintz SR, Rice H, Courtney SE, Lally KP, Ambalavanan N, Bendel CM, Bui KCT, Calkins C, Chandler NM, Dasgupta R, Davis JM, Deans K, DeUgarte DA, Gander J, Jackson CA, Keszler M, Kling K, Fenton SJ, Fisher KA, Hartman T, Huang EY, Islam S, Koch F, Lainwala S, Lesher A, Lopez M, Misra M, Overbey J, Poindexter B, Russell R, Stylianos S, Tamura DY, Yoder BA, Lucas D, Shaul D, Ham PB 3rd, Fitzpatrick C, Calkins K, Garrison A, de la Cruz D, Abdessalam S, Kvasnovsky C, Segura BJ, Shilyansky J, Smith LM, Tyson JE. Effect of Early vs Late Inguinal Hernia Repair on Serious Adverse Event Rates in Preterm Infants: A Randomized Clinical Trial. JAMA. 2024 Mar 26;331(12):1035-1044. doi: 10.1001/jama.2024.2302. |
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| IH repair at 55-60 weeks post-menstrual age | Procedure | The IH repair will be performed as an outpatient between approximately 55-60 weeks post-menstrual age. |
|
Mean BSID scores; primarily cognitive domain |
| 22-26 months corrected age |
| University of Arkansas for Medical Sciences; Arkansas Children's Hospital |
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| Southern California Permanente Group | Los Angeles | California | 90027 | United States |
| University of California, Los Angeles David Geffen School of Medicine; Mattel Children's & LA Biomed | Los Angeles | California | 90095 | United States |
| Valley Children's Hospital | Madera | California | 93636 | United States |
| Naval Medical Center San Diego | San Diego | California | 92103 | United States |
| UCSD Rady Children's Hospital | San Diego | California | 92123 | United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| UF Health Shands Children's Hospital | Gainesville | Florida | 32608 | United States |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| University of Minnesota Medical School; Amplatz Children's Hospital | Minneapolis | Minnesota | 55455 | United States |
| SSM Health Cardinal Glennon Children's Hospital | St Louis | Missouri | 63104 | United States |
| Washington University School of Medicine in St. Louis; St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Children's Hospital & Medical Center of Omaha | Omaha | Nebraska | 68114 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Oishei Children's Hospital of Buffalo | Buffalo | New York | 14203 | United States |
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| Cohen Children's Medical Center | Queens | New York | 11040 | United States |
| Duke University Medical Center; Duke Children's Hospital and Health Center | Durham | North Carolina | 27710 | United States |
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Ohio State University College of Medicine; Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | United States |
| OHSU Doernbecher Children's Hospital | Portland | Oregon | 97239 | United States |
| Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Children's Hospital at Erlanger UT Chattanooga | Chattanooga | Tennessee | 37403 | United States |
| University of Tennessee Health Science Center; Le Bonheur Children's Hospital | Memphis | Tennessee | 38103 | United States |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | United States |
| University of Texas, Southwestern Medical Center; Children's Medical Center | Dallas | Texas | 75235 | United States |
| Baylor College of Medicine; Texas Children's Hospital | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| Primary Children's Hospital University of Utah | Salt Lake City | Utah | 84113 | United States |
| UVA Children's Hospital | Charlottesville | Virginia | 22903 | United States |
| Virginia Commonwealth University Medical Center; Children's Hospital of Richmond | Richmond | Virginia | 23284 | United States |
| University of Washington School of Medicine; Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Medical College of Wisconsin; Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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