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

Use our guide to learn which trials are right for you!

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
Nashville, Tennessee 37232
Principal Investigator: Martin Blakely, MD, MS
Phone: 615-936-1050
?
mi
from
Nashville, TN
Click here to add this to my saved trials
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
?
mi
from
Akron, OH
Click here to add this to my saved trials
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...
?
mi
from
Boston, MA
Click here to add this to my saved trials
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...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Albany, New York 12208
Principal Investigator: Elizabeth Renaud, MD
Phone: 518-262-5421
?
mi
from
Albany, NY
Click here to add this to my saved trials
Birmingham, Alabama
Principal Investigator: Robert Russell, MD, MPH
Phone: 205-638-9688
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
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...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Columbus, Ohio
Principal Investigator: Katherine Deans, MD, MHSc
Phone: 614-355-3078
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Dallas, Texas
Principal Investigator: Adam Alder, MD
Phone: 214-456-6040
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Durham, North Carolina
Principal Investigator: Obinna Adibe, MD
Phone: 919-681-4913
?
mi
from
Durham, NC
Click here to add this to my saved trials
Houston, Texas
Principal Investigator: Monica Lopez, MD
Phone: 832-822-3135
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas
Principal Investigator: KuoJen Tsao, MD
Phone: 713-500-7481
?
mi
from
Houston, TX
Click here to add this to my saved trials
Kansas City, Missouri
Principal Investigator: Shawn St. Peter, MD
Phone: 816-234-3199
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Little Rock, Arkansas
Principal Investigator: Sid Dassinger, MD
Phone: 501-364-4000
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Los Angeles, California 90027
Principal Investigator: Donald Shaul, MD
Phone: 626-243-8915
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90095
Principal Investigator: Daniel DeUgarte, MD FACS FAAP
Phone: 310-206-2429
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Memphis, Tennessee
Principal Investigator: Eunice Huang, MD, MS
Phone: 901-287-5324
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Milwaukee, Wisconsin 53226
Principal Investigator: Casey Calkins, MD
Phone: 414-266-6551
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Minneapolis, Minnesota
Principal Investigator: Brad Segura, MD, PhD
Phone: 612-365-6777
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Richmond, Virginia
Principal Investigator: Jeffrey Haynes, MD FACS FAAP
Phone: 434-243-7653
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Seattle, Washington
Principal Investigator: Adam Goldin, MD, MPH
Phone: 206-987-2794
?
mi
from
Seattle, WA
Click here to add this to my saved trials
St. Louis, Missouri 63110
Principal Investigator: Jacqueline Saito, MD, MSCI
Phone: 314-454-6022
?
mi
from
St. Louis, MO
Click here to add this to my saved trials