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
	
								Dallas, Texas 			
	
			
					Principal Investigator: Adam Alder, MD
			
						
										Phone: 214-456-6040
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									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  
  
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									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...  
  
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									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...  
  
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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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									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...  
  
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								Columbus, Ohio 			
	
			
					Principal Investigator: Katherine Deans, MD, MHSc
			
						
										Phone: 614-355-3078
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								Durham, North Carolina 			
	
			
					Principal Investigator: Obinna Adibe, MD
			
						
										Phone: 919-681-4913
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								Houston, Texas 			
	
			
					Principal Investigator: Monica Lopez, MD
			
						
										Phone: 832-822-3135
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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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								Los Angeles, California 90027			
	
			
					Principal Investigator: Donald Shaul, MD
			
						
										Phone: 626-243-8915
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			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
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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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