Inguinal HerniaNCT01678638
Timing of Inguinal Hernia Repair in Premature Infants
A study testing IH repair before NICU discharge and IH repair at 55-60 weeks post-menstrual age in people with Inguinal Hernia and Premature Birth of Newborn, run by Vanderbilt University Medical Center at 40 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 37 weeks
- Conditions the study is for
- Inguinal Hernia, Premature Birth of Newborn
- What is being tested?
- IH repair before NICU discharge and IH repair at 55-60 weeks post-menstrual age
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 40 sitesUnited States
- Study dates
- Jun 2013to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant with estimated gestational age at birth of < 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
Who cannot join
- 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 impacts neurodevelopmental outcome or chromosomal abnormality
- Family unable to return for follow up and later IH repair; or likely unable to monitor IH as outpatient
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Akron Children's Hospital
Akron, Ohio, 44308
Albany Medical Center
Albany, New York, 12208
University of Alabama at Birmingham School of Medicine; Children's Hospital of Alabama
Birmingham, Alabama, 35233
Tufts Medical Center
Boston, Massachusetts, 02111
Oishei Children's Hospital of Buffalo
Buffalo, New York, 14203
Medical University of South Carolina
Charleston, South Carolina, 29425
UVA Children's Hospital
Charlottesville, Virginia, 22903
Children's Hospital at Erlanger UT Chattanooga
Chattanooga, Tennessee, 37403
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Ohio State University College of Medicine; Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas, Southwestern Medical Center; Children's Medical Center
Dallas, Texas, 75235
Dayton Children's Hospital
Dayton, Ohio, 45404
Duke University Medical Center; Duke Children's Hospital and Health Center
Durham, North Carolina, 27710
UF Health Shands Children's Hospital
Gainesville, Florida, 32608
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Baylor College of Medicine; Texas Children's Hospital
Houston, Texas, 77030
University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Arkansas for Medical Sciences; Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Southern California Permanente Group
Los Angeles, California, 90027
University of California, Los Angeles David Geffen School of Medicine; Mattel Children's & LA Biomed
Los Angeles, California, 90095
Valley Children's Hospital
Madera, California, 93636
University of Tennessee Health Science Center; Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
Medical College of Wisconsin; Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota Medical School; Amplatz Children's Hospital
Minneapolis, Minnesota, 55455
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Columbia University Irving Medical Center
New York, New York, 10032
Children's Hospital & Medical Center of Omaha
Omaha, Nebraska, 68114
OHSU Doernbecher Children's Hospital
Portland, Oregon, 97239
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
Cohen Children's Medical Center
Queens, New York, 11040
Virginia Commonwealth University Medical Center; Children's Hospital of Richmond
Richmond, Virginia, 23284
Primary Children's Hospital University of Utah
Salt Lake City, Utah, 84113
Naval Medical Center San Diego
San Diego, California, 92103
UCSD Rady Children's Hospital
San Diego, California, 92123
University of Washington School of Medicine; Seattle Children's Hospital
Seattle, Washington, 98105
SSM Health Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
Washington University School of Medicine in St. Louis; St. Louis Children's Hospital
St Louis, Missouri, 63110
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
About this study
Official title: 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.
Read the 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.
- Conditions
- Inguinal Hernia, Premature Birth of Newborn
- Being tested
- IH repair before NICU discharge, IH repair at 55-60 weeks post-menstrual age
- Keywords
- inguinal hernia, premature infants, anesthesia safety, neurodevelopmental outcome, preterm infants, neonatal prematurity
- Medical subject headings
- Hernia, Inguinal, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IH repair before NICU dischargeProcedure or surgery
The IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization)
IH repair at 55-60 weeks post-menstrual ageProcedure or surgery
The IH repair will be performed as an outpatient between approximately 55-60 weeks post-menstrual age.
| Study group | Role | What they receive |
|---|---|---|
| Early inguinal hernia (IH) repair | Active comparator | IH repair before NICU discharge Receives: Procedure: IH repair before NICU discharge |
| Late inguinal hernia (IH) repair | Active comparator | IH repair as outpatient at approximately 55-60 weeks post-menstrual age Receives: Procedure: IH repair at 55-60 weeks post-menstrual age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant adverse event (SAE) rate
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.
Measured: 9 months beyond NICU discharge
Number of hospital days
Total number of hospital days
Measured: From randomization until 9 months post NICU discharge
Secondary outcomes (2)
Hospital costs
Departmental level costs at each participating institution will be determined for care that occurs from randomization until 9 months post NICU discharge.
Measured: Enrollment through 9 months after NICU discharge
Bayley Scales of Infant Development, 3rd Edition
Mean BSID scores; primarily cognitive domain
Measured: 22-26 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startJun 2013
- Primary completionApr 2023
- Study completionSep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Blakely, Vanderbilt University Medical Center
- Investigators
- Martin L Blakely, MD, MS, Principal investigator, Vanderbilt University Medical CenterJon E Tyson, MD, MPH, Principal investigator, University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678638
- Sponsor's protocol ID
- 11-225-01
- Status last verified
- Oct 2023
- First submitted
- 30 Aug 2012
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
HIP Trial Investigators; Blakely ML, Krzyzaniak A, Dassinger MS, Pedroza C, Weitkamp JH, Gosain A, Cotten M, Hintz SR, Rice H, Courtney SE, Lally KP, Ambalavanan N, Bendel CM, Bui KCT, Calkins C, Chandler NM, Dasgupta R, Davis JM, Deans K, DeUgarte DA, Gander J, Jackson CA, Keszler M, Kling K, Fenton SJ, Fisher KA, Hartman T, Huang EY, Islam S, Koch F, Lainwala S, Lesher A, Lopez M, Misra M, Overbey J, Poindexter B, Russell R, Stylianos S, Tamura DY, Yoder BA, Lucas D, Shaul D, Ham PB 3rd, Fitzpatrick C, Calkins K, Garrison A, de la Cruz D, Abdessalam S, Kvasnovsky C, Segura BJ, Shilyansky J, Smith LM, Tyson JE. Effect of Early vs Late Inguinal Hernia Repair on Serious Adverse Event Rates in Preterm Infants: A Randomized Clinical Trial. JAMA. 2024 Mar 26;331(12):1035-1044. doi: 10.1001/jama.2024.2302.
PubMed 38530261
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Inguinal Hernia Repair in Premature Infants: A Randomized Trial
- ClinicalTrials.gov ID
- NCT01678638
- Acronym / sponsor ID
- 11-225-01
- Conditions
- Inguinal Hernia, Premature Birth of Newborn
- Keywords
- inguinal hernia, premature infants, anesthesia safety, neurodevelopmental outcome, preterm infants, neonatal prematurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston
- Study start
- Jun 2013
- Primary completion
- Apr 2023 (actual)
- Study completion
- Sep 2023 (actual)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early inguinal hernia (IH) repair | Active comparator | Procedure: IH repair before NICU dischargeIH repair before NICU discharge |
| Late inguinal hernia (IH) repair | Active comparator | Procedure: IH repair at 55-60 weeks post-menstrual ageIH repair as outpatient at approximately 55-60 weeks post-menstrual age |
Who may qualify
- Ages
- Up to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infant with estimated gestational age at birth of < 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
Key exclusion criteria (3 listed)
- 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 impacts neurodevelopmental outcome or chromosomal abnormality
- Family unable to return for follow up and later IH repair; or likely unable to monitor IH as outpatient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IH repair before NICU dischargeThe IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization) | Procedure or surgery | Early inguinal hernia (IH) repair |
| IH repair at 55-60 weeks post-menstrual ageThe IH repair will be performed as an outpatient between approximately 55-60 weeks post-menstrual age. | Procedure or surgery | Late inguinal hernia (IH) repair |
Primary outcome
Significant adverse event (SAE) rate
Time frame: 9 months beyond NICU discharge
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
Total number of hospital days
2 secondary outcomes
Hospital costs
Time frame: Enrollment through 9 months after NICU discharge
Bayley Scales of Infant Development, 3rd Edition
Time frame: 22-26 months corrected age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Derived from this study: PubMed 38530261HIP Trial Investigators; Blakely ML, Krzyzaniak A, Dassinger MS, Pedroza C, Weitkamp JH, Gosain A, Cotten M, Hintz SR, Rice H, Courtney SE, Lally KP, Ambalavanan N, Bendel CM, Bui KCT, Calkins C, Chandler NM, Dasgupta R, Davis JM, Deans K, DeUgarte DA, Gander J, Jackson CA, Keszler M, Kling K, Fenton SJ, Fisher KA, Hartman T, Huang EY, Islam S, Koch F, Lainwala S, Lesher A, Lopez M, Misra M, Overbey J, Poindexter B, Russell R, Stylianos S, Tamura DY, Yoder BA, Lucas D, Shaul D, Ham PB 3rd, Fitzpatrick C, Calkins K, Garrison A, de la Cruz D, Abdessalam S, Kvasnovsky C, Segura BJ, Shilyansky J, Smith LM, Tyson JE. Effect of Early vs Late Inguinal Hernia Repair on Serious Adverse Event Rates in Preterm Infants: A Randomized Clinical Trial. JAMA. 2024 Mar 26;331(12):1035-1044. doi: 10.1001/jama.2024.2302.
- Individual participant dataSharing planned: No
Related trials for Inguinal Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin L Blakely, MD, MS principal investigator
Vanderbilt University Medical Center
Jon E Tyson, MD, MPH principal investigator
University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IH repair before NICU discharge and IH repair at 55-60 weeks post-menstrual age in people with Inguinal Hernia and Premature Birth of Newborn, run by Vanderbilt University Medical Center at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant adverse event (SAE) rate (time frame: 9 months beyond NICU discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01678638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.