Timing of Inguinal Hernia Repair in Premature Infants
This study is not yet open for participant recruitment.
Verified September 2012 by Vanderbilt University
Sponsor:
Vanderbilt University
Collaborator:
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Martin Blakely, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01678638
First received: August 30, 2012
Last updated: September 4, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Inguinal Hernia Prematurity |
Procedure: IH repair before NICU discharge Procedure: IH repair at 55-60 weeks post-menstrual age |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Timing of Inguinal Hernia Repair in Premature Infants: A Randomized Trial |
Resource links provided by NLM:
Further study details as provided by Vanderbilt University:
Primary Outcome Measures:
- Significant adverse event (SAE) rate [ Time Frame: 9 months beyond NICU discharge ] [ Designated as safety issue: Yes ]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.
- Number of hospital days [ Time Frame: From randomization until 9 months post NICU discharge ] [ Designated as safety issue: Yes ]Total number of hospital days
Secondary Outcome Measures:
- Hospital costs [ Time Frame: Enrollment through 9 months after NICU discharge ] [ Designated as safety issue: No ]Departmental level costs at each participating institution will be determined for care that occurs from randomization until 9 months post NICU discharge.
- Bayley Scales of Infant Development, 3rd Edition [ Time Frame: 22-26 months corrected age ] [ Designated as safety issue: Yes ]Mean BSID scores; primarily cognitive domain
| Estimated Enrollment: | 600 |
| Study Start Date: | July 2013 |
| Estimated Study Completion Date: | June 2018 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Early inguinal hernia (IH) repair
IH repair before NICU discharge
|
Procedure: IH repair before NICU discharge
The IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization)
|
|
Active Comparator: Late inguinal hernia (IH) repair
IH repair at 55-60 weeks post-menstrual age
|
Procedure: IH repair at 55-60 weeks post-menstrual age
The IH repair will be performed between 55-60 weeks post-menstrual age.
|
Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Infant with estimated gestational age < 37 weeks, 0 days
- In a NICU at participating site
- Diagnosed with an IH per the pediatric surgery team
- Parents and providers willing to randomize the infant
Exclusion Criteria:
- Associated anomaly that impacts timing of IH repair (e.g. severe cardiac anomalies might preclude early IH repair)
- Infant is undergoing another operative procedure and IH repair is planned as a secondary procedure (e.g. fundoplication or G tube is planned, and IH repair is considered a secondary procedure)
- Family unable / unwilling to return for follow up and later IH repair; or likely unable to monitor IH as outpatient
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678638
Contacts
| Contact: Martin L Blakely, MD, MS | 6159361050 | martin.blakely@vanderbilt.edu |
| Contact: Jamie Tice, BSN | 6159361050 ext 8749 | jamie.tice@vanderbilt.edu |
Locations
| United States, Alabama | |
| University of Alabama at Birmingham School of Medicine; Children's Hospital of Alabama | Not yet recruiting |
| Birmingham, Alabama, United States | |
| Contact: Robert Russell, MD, MPH 205-638-9688 | |
| Principal Investigator: Robert Russell, MD, MPH | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences; Arkansas Children's Hospital | Not yet recruiting |
| Little Rock, Arkansas, United States | |
| Contact: Sid Dassinger, MD 501-364-4000 | |
| Principal Investigator: Sid Dassinger, MD | |
| United States, California | |
| University of California, Los Angeles David Geffen School of Medicine; Mattel Children's Hospital | Not yet recruiting |
| Los Angeles, California, United States | |
| Contact: Daniel DeUgarte, MD FACS FAAP 310-206-2429 | |
| Principal Investigator: Daniel DeUgarte, MD FACS FAAP | |
| University of Southern California Keck School of Medicine; Children's Hospital Los Angeles | Not yet recruiting |
| Los Angeles, California, United States | |
| Contact: Akemi Kawaguchi, MD 323-361-5065 | |
| Principal Investigator: Akemi Kawaguchi, MD | |
| United States, Michigan | |
| University of Michigan Medical Center; C.S. Mott Children's Hospital | Not yet recruiting |
| Ann Arbor, Michigan, United States | |
| Contact: Steven Bruch, MD, M.Sc 734-764-4151 | |
| Principal Investigator: Steven Bruch, MD, M.Sc | |
| United States, Minnesota | |
| University of Minnesota Medical School; Amplatz Children's Hospital | Not yet recruiting |
| Minneapolis, Minnesota, United States | |
| Contact: Brad Segura, MD, PhD 612-365-6777 | |
| Principal Investigator: Brad Segura, MD, PhD | |
| United States, Missouri | |
| University of Missouri- Kansas City Medical School; Children's Mercy Hospital | Not yet recruiting |
| Kansas City, Missouri, United States | |
| Contact: Shawn St. Peter, MD 816-234-3199 | |
| Principal Investigator: Shawn St. Peter, MD | |
| Washington University School of Medicine in St. Louis; St. Louis Children's Hospital | Not yet recruiting |
| St. Louis, Missouri, United States | |
| Contact: Jacqueline Saito, MD, MSCI 314-454-6022 | |
| Principal Investigator: Jacqueline Saito, MD, MSCI | |
| United States, North Carolina | |
| Duke University Medical Center; Duke Children's Hospital and Health Center | Not yet recruiting |
| Durham, North Carolina, United States | |
| Contact: Obinna Adibe, MD 919-681-5077 | |
| Principal Investigator: Obinna Adibe, MD | |
| United States, Ohio | |
| Ohio State University College of Medicine; Nationwide Children's Hospital | Not yet recruiting |
| Columbus, Ohio, United States | |
| Contact: Katherine Deans, MD, MHSc 614-722-3900 | |
| Principal Investigator: Katherine Deans, MD, MHSc | |
| United States, South Carolina | |
| Medical University of South Carolina; Medical University of South Carolina Children's Hospital | Not yet recruiting |
| Charleston, South Carolina, United States | |
| Contact: Christian Streck, MD FACS FAAP 843-792-3851 | |
| Principal Investigator: Christian Streck, MD FACS FAAP | |
| United States, Tennessee | |
| University of Tennessee Health Science Center; Le Bonheur Children's Hospital | Not yet recruiting |
| Memphis, Tennessee, United States | |
| Contact: Eunice Huang, MD, MS 901-287-6031 | |
| Principal Investigator: Eunice Huang, MD, MS | |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Not yet recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Martin L Blakely, MD, MS 615-936-1050 martin.blakely@vanderbilt.edu | |
| Contact: Jamie Tice, BSN 615-936-1050 ext 8749 jamie.tice@vanderbilt.edu | |
| Principal Investigator: Martin Blakely, MD, MS | |
| United States, Texas | |
| University of Texas, Southwestern Medical Center; Children's Medical Center | Not yet recruiting |
| Dallas, Texas, United States | |
| Contact: Li Ern Chen, MD 214-730-5437 | |
| Principal Investigator: Li Ern Chen, MD | |
| Baylor College of Medicine; Texas Children's Hospital | Not yet recruiting |
| Houston, Texas, United States | |
| Contact: Monica Lopez, MD 832-822-3135 | |
| Principal Investigator: Monica Lopez, MD | |
| University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital | Not yet recruiting |
| Houston, Texas, United States | |
| Contact: KuoJen Tsao, MD 832-325-7234 | |
| Principal Investigator: KuoJen Tsao, MD | |
| United States, Virginia | |
| Virginia Commonwealth University Medical Center; Children's Hospital of Richmond | Not yet recruiting |
| Richmond, Virginia, United States | |
| Contact: Jeffrey Haynes, MD FACS FAAP 804-828-3500 | |
| Principal Investigator: Jeffrey Haynes, MD FACS FAAP | |
| United States, Washington | |
| University of Washington School of Medicine; Seattle Children's Hospital | Not yet recruiting |
| Seattle, Washington, United States | |
| Contact: Adam Goldin, MD, MPH 206-987-2794 | |
| Principal Investigator: Adam Goldin, MD, MPH | |
| United States, Wisconsin | |
| Medical College of Wisconsin; Children's Hospital of Wisconsin | Not yet recruiting |
| Milwaukee, Wisconsin, United States | |
| Contact: Casey Calkins, MD 414-266-6550 | |
| Principal Investigator: Casey Calkins, MD | |
Sponsors and Collaborators
Vanderbilt University
The University of Texas Health Science Center, Houston
Investigators
| Principal Investigator: | Martin L Blakely, MD, MS | Vanderbilt University |
| Principal Investigator: | Jon E Tyson, MD, MPH | University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital |
More Information
No publications provided
| Responsible Party: | Martin Blakely, Associate Professor of Pediatric Surgery and Pediatrics, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT01678638 History of Changes |
| Other Study ID Numbers: | 11-225-01 |
| Study First Received: | August 30, 2012 |
| Last Updated: | September 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
|
inguinal hernia prematurity anesthesia safety neurodevelopmental outcome |
Additional relevant MeSH terms:
|
Hernia Hernia, Inguinal Pathological Conditions, Anatomical Hernia, Abdominal |
ClinicalTrials.gov processed this record on May 19, 2013