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 |
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.
(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.
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
171 Ashley Avenue
Charleston, South Carolina 29425
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...
Click here to add this to my saved trials
1 Perkins Square
Akron, Ohio 44308
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
Click here to add this to my saved trials
800 Washington St
Boston, Massachusetts 02111
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...
Click here to add this to my saved trials
101 Jessup Hall
Iowa City, Iowa 52242
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...
Click here to add this to my saved trials
Albany, New York 12208
Principal Investigator: Elizabeth Renaud, MD
Phone: 518-262-5421
Click here to add this to my saved trials
Birmingham, Alabama
Principal Investigator: Robert Russell, MD, MPH
Phone: 205-638-9688
Click here to add this to my saved trials
Columbus, Ohio
Principal Investigator: Katherine Deans, MD, MHSc
Phone: 614-355-3078
Click here to add this to my saved trials
Dallas, Texas
Principal Investigator: Adam Alder, MD
Phone: 214-456-6040
Click here to add this to my saved trials
Durham, North Carolina
Principal Investigator: Obinna Adibe, MD
Phone: 919-681-4913
Click here to add this to my saved trials
Houston, Texas
Principal Investigator: Monica Lopez, MD
Phone: 832-822-3135
Click here to add this to my saved trials
Houston, Texas
Principal Investigator: KuoJen Tsao, MD
Phone: 713-500-7481
Click here to add this to my saved trials
Kansas City, Missouri
Principal Investigator: Shawn St. Peter, MD
Phone: 816-234-3199
Click here to add this to my saved trials
Little Rock, Arkansas
Principal Investigator: Sid Dassinger, MD
Phone: 501-364-4000
Click here to add this to my saved trials
Los Angeles, California 90027
Principal Investigator: Donald Shaul, MD
Phone: 626-243-8915
Click here to add this to my saved trials
University of California, Los Angeles David Geffen School of Medicine; Mattel Children's & LA Biomed
Los Angeles, California 90095
Principal Investigator: Daniel DeUgarte, MD FACS FAAP
Phone: 310-206-2429
Click here to add this to my saved trials
Memphis, Tennessee
Principal Investigator: Eunice Huang, MD, MS
Phone: 901-287-5324
Click here to add this to my saved trials
Milwaukee, Wisconsin 53226
Principal Investigator: Casey Calkins, MD
Phone: 414-266-6551
Click here to add this to my saved trials
Minneapolis, Minnesota
Principal Investigator: Brad Segura, MD, PhD
Phone: 612-365-6777
Click here to add this to my saved trials
Nashville, Tennessee 37232
Principal Investigator: Martin Blakely, MD, MS
Phone: 615-936-1050
Click here to add this to my saved trials
Richmond, Virginia
Principal Investigator: Jeffrey Haynes, MD FACS FAAP
Phone: 434-243-7653
Click here to add this to my saved trials
Seattle, Washington
Principal Investigator: Adam Goldin, MD, MPH
Phone: 206-987-2794
Click here to add this to my saved trials
St. Louis, Missouri 63110
Principal Investigator: Jacqueline Saito, MD, MSCI
Phone: 314-454-6022
Click here to add this to my saved trials