Timing of Inguinal Hernia Repair in Premature Infants



Status:Recruiting
Conditions:Women's Studies, Gastrointestinal
Therapuetic Areas:Gastroenterology, Reproductive
Healthy:No
Age Range:Any
Updated:5/14/2016
Start Date:June 2013
End Date:June 2019
Contact:Martin L Blakely, MD, MS
Email:martin.blakely@vanderbilt.edu
Phone:6159361050

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Timing of Inguinal Hernia Repair in Premature Infants: A Randomized Trial

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.

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:

- 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)

- Known major congenital anomaly that impact neurodevelopmental outcome or chromosomal
abnormality

- Family unable / unwilling to return for follow up and later IH repair; or likely
unable to monitor IH as outpatient
We found this trial at
22
sites
Houston, Texas
Principal Investigator: Monica Lopez, MD
Phone: 832-822-3135
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1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Principal Investigator: Aaron Garrison, MD
Phone: 300-543-8350
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Howard Jen, MD
Phone: 617-636-5322
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Joel Shilyansky, MD
Phone: 319-356-2924
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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Albany, New York 12208
Principal Investigator: Elizabeth Renaud, MD
Phone: 518-262-5421
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Birmingham, Alabama
Principal Investigator: Robert Russell, MD, MPH
Phone: 205-638-9688
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Birmingham, AL
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Aaron Lesher, MD
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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Columbus, Ohio
Principal Investigator: Katherine Deans, MD, MHSc
Phone: 614-355-3078
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Columbus, OH
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Dallas, Texas
Principal Investigator: Adam Alder, MD
Phone: 214-456-6040
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Dallas, TX
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Durham, North Carolina
Principal Investigator: Obinna Adibe, MD
Phone: 919-681-4913
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Durham, NC
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Houston, Texas
Principal Investigator: KuoJen Tsao, MD
Phone: 713-500-7481
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Kansas City, Missouri
Principal Investigator: Shawn St. Peter, MD
Phone: 816-234-3199
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Little Rock, Arkansas
Principal Investigator: Sid Dassinger, MD
Phone: 501-364-4000
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Little Rock, AR
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Los Angeles, California 90027
Principal Investigator: Donald Shaul, MD
Phone: 626-243-8915
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Los Angeles, California 90095
Principal Investigator: Daniel DeUgarte, MD FACS FAAP
Phone: 310-206-2429
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Memphis, Tennessee
Principal Investigator: Eunice Huang, MD, MS
Phone: 901-287-5324
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Milwaukee, Wisconsin 53226
Principal Investigator: Casey Calkins, MD
Phone: 414-266-6551
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Minneapolis, Minnesota
Principal Investigator: Brad Segura, MD, PhD
Phone: 612-365-6777
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Nashville, Tennessee 37232
Principal Investigator: Martin Blakely, MD, MS
Phone: 615-936-1050
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Richmond, Virginia
Principal Investigator: Jeffrey Haynes, MD FACS FAAP
Phone: 434-243-7653
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Seattle, Washington
Principal Investigator: Adam Goldin, MD, MPH
Phone: 206-987-2794
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St. Louis, Missouri 63110
Principal Investigator: Jacqueline Saito, MD, MSCI
Phone: 314-454-6022
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