Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
Public ClinicalTrials.gov record NCT01029353. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-center Randomized Trial of Laparotomy vs. Drainage as the Initial Surgical Therapy for ELBW Infants With Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP): Outcomes at 18-22 Months Adjusted Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight infants (≤1,000 g). Infants diagnosed with NEC or IP requiring surgical intervention, will be recruited. Subjects will be randomized to receive either a laparotomy or peritoneal drainage. Primary outcome is impairment-free survival at 18-22 months corrected age.
Study identification
- NCT ID
- NCT01029353
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 529 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 8 Weeks
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2010 (Actual)
- Primary completion
- Aug 2019 (Actual)
- Completion
- Aug 2019 (Actual)
- Last update posted
- Jul 18, 2024
2010 – 2019
United States locations
- U.S. sites
- 22
- U.S. states
- 17
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| University of California - Los Angeles | Los Angeles | California | 90025 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| Yale University | New Haven | Connecticut | 06504 | — |
| Emory University | Atlanta | Georgia | 30303 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| RTI International | Durham | North Carolina | 27705 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| Cincinnati Children's Medical Center | Cincinnati | Ohio | 45267 | — |
| Case Western Reserve University | Cleveland | Ohio | 44106 | — |
| Research Institute at Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Univeristy of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | — |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | — |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| University of Utah | Salt Lake City | Utah | 84108 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01029353, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 18, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01029353 live on ClinicalTrials.gov.