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Infant, NewbornNEC SurgeryNCT01223261

Observational Study of Surgical Treatment of Necrotizing Enterocolotis

An observational study of Infant, Newborn and Infant, Low Birth Weight, run by NICHD Neonatal Research Network at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purposes of this study were: 1) to compare mortality and postoperative morbidities in extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP); 2) to determine the ability to distinguish NEC from IP… Read more about this study

Who is it for?
Ages Up to 6 weeks
How many people
156 participants
Where
17 sitesUnited States
Study dates
Mar 2001to Mar 2004
Phase
Observational
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 6 weeks
  • All sexes
  • No healthy volunteers
  • Child

Study population: Extremely Low Birth Weight (ELBW) infants (those with birth weights <1000 g) born at participating NRN Centers diagnosed by a pediatric surgeon and neonatologist as having either necrotizing enterocolitis (NEC) or intestinal perforation (IP) requiring surgical intervention.

Who may be able to join

  • Infants born 401-1,000 grams at birth enrolled in the NRN Generic Database
  • Sage III NEC or isolated intestinal perforation
  • Pediatric surgeon decision to perform surgery for suspected NEC or IP

Who cannot join

  • Decision not to treat

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Emory University

    Atlanta, Georgia, 30303

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Wake Forest University

    Charlotte, North Carolina, 27157

  • Cincinnati Children's Medical Center

    Cincinnati, Ohio, 45267

  • Case Western Reserve University, Rainbow Babies and Children's Hospital

    Cleveland, Ohio, 44106

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75235

  • Wayne State University

    Detroit, Michigan, 48201

  • RTI International

    Durham, North Carolina, 27705

  • Duke University

    Durham, North Carolina, 27710

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • University of Miami

    Miami, Florida, 33136

  • Yale University

    New Haven, Connecticut, 06504

  • Stanford University

    Palo Alto, California, 94304

  • Brown University, Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • University of Rochester

    Rochester, New York, 14642

  • University of California at San Diego

    San Diego, California, 92103-8774

Other trials in United States

About this study

Official title: Observational Study of Surgical Treatment of Necrotizing Enterocolotis or Isolated Intestinal Perforation

The purposes of this study were: 1) to compare mortality and postoperative morbidities in extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP); 2) to determine the ability to distinguish NEC from IP preoperatively and the importance of this distinction on outcome measures; and 3) to evaluate the association between extent of intestinal disease determined at operation and outcome measures. All ELBW infants born at participating NRN centers were screened for the presence of NEC or IP that was thought by the pediatric surgeon and neonatologist to require surgical intervention. Data were collected enrolled infants, including: intraoperative findings recorded by the surgeon and specific post-operative complications. Neurodevelopmental examinations were conducted on surviving infants at 18-22 months corrected age.

Read the detailed description

Necrotizing enterocolitis (NEC) is a condition, generally affecting premature infants, in which the intestines become ischemic (lack oxygen and/or blood flow). NEC occurs in up to 5-15% of extremely low birth weight (ELBW) infants. Isolated or focal intestinal perforation (IP) is a less common condition, affecting an estimated 4% of ELBWs, in which a hole develops in the intestines leaking fluid into the abdomin. The outcomes for infants with NEC or IP are poor: 49% die and half of the surviving infants are neurodevelopmentally impaired.

Surgical options for NEC and IP include two possible procedures: peritoneal drainage, in which a tube is placed in the abdominal cavity through a small incision for fluid to drain out; or laparotomy, in which an incision is made in the abdomen and diseased intestine is removed. Infants treated with an initial drainage sometimes go on to need a laparotomy. Most surgeons now believe that a diagnosis of the intestinal perforation (IP) may actually be either true NEC or a different and distinct pathology, termed isolated intestinal perforation. The ability to distinguish these 2 conditions preoperatively, based on perinatal characteristics, physical examination findings, and findings on abdominal plain film imaging, remains unknown. If these 2 entities can be distinguished preoperatively, the intervention chosen and outcomes may be different. From the two available surgical options, tt is not known whether initial laparotomy or peritoneal drain placement is more effective for either NEC or IP.

This study was a prospective, multicenter observational study to describe the surgical outcomes (mortality, post-operative intestinal stricture, intra-abdominal abscess formation, etc.) in ELBW infants with either NEC or IP who underwent initial laparotomy or peritoneal drainage. We also evaluated the ability of surgeons to distinguish NEC and IP pre-operatively and the relevance of this distinction on outcome. Finally, an analysis of the impact of extent of intestinal involvement with NEC on outcome measures is reported.

All ELBW infants born at participating NRN centers were screened for the presence of NEC or IP that was thought by the pediatric surgeon and neonatologist to require surgical intervention. Data were collected enrolled infants, including: intraoperative findings recorded by the surgeon and specific post-operative complications.

Neurodevelopmental examinations were conducted on surviving infants at 18-22 months corrected age.

Keywords
NICHD Neonatal Research Network, Very Low Birth Weight (VLBW), Extremely Low Birth Weight (ELBW), Prematurity, Laparotomy, Drainage, Isolated intestinal perforation, Focal intestinal performation
Medical subject headings
Premature Birth, Enterocolitis, Necrotizing, Intestinal Perforation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of conducting a randomized trial

    Ability to enroll infants in a 1-year period

    Measured: 1 year

Secondary outcomes (4)

  1. Document variation in current surgical practices

    Measured: Until hospital discharge or 120 days of life

  2. Prevalence of infants who would qualify for the study

    Measured: Until hospital discharge or 120 days of life

  3. Frequency of postoperative complications

    Measured: Until hospital discharge or 120 days of life

  4. Neurodevelopmental impairment

    Measured: 18-22 months corrected age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2010 (estimated)
  2. Study startMar 2001
  3. Primary completionSep 2002
  4. Study completionMar 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01223261
Sponsor's protocol ID
NICHD-NRN-0027
Other IDs
U10HD034216, U10HD027904, U10HD021364, M01RR000080, U10HD027853, M01RR008084, U10HD027851, M01RR000039
Acronym
NEC Surgery
Status last verified
Mar 2019
First submitted
14 Oct 2010
Last updated
22 Mar 2019
Results posted
No
Data monitoring committee
No

Publications

  • Blakely ML, Lally KP, McDonald S, Brown RL, Barnhart DC, Ricketts RR, Thompson WR, Scherer LR, Klein MD, Letton RW, Chwals WJ, Touloukian RJ, Kurkchubasche AG, Skinner MA, Moss RL, Hilfiker ML; NEC Subcommittee of the NICHD Neonatal Research Network. Postoperative outcomes of extremely low birth-weight infants with necrotizing enterocolitis or isolated intestinal perforation: a prospective cohort study by the NICHD Neonatal Research Network. Ann Surg. 2005 Jun;241(6):984-9; discussion 989-94. doi: 10.1097/01.sla.0000164181.67862.7f.

    PubMed 15912048

  • Blakely ML, Tyson JE, Lally KP, McDonald S, Stoll BJ, Stevenson DK, Poole WK, Jobe AH, Wright LL, Higgins RD; NICHD Neonatal Research Network. Laparotomy versus peritoneal drainage for necrotizing enterocolitis or isolated intestinal perforation in extremely low birth weight infants: outcomes through 18 months adjusted age. Pediatrics. 2006 Apr;117(4):e680-7. doi: 10.1542/peds.2005-1273. Epub 2006 Mar 20.

    PubMed 16549503

Questions about this trial

What is this clinical trial studying?

An observational study of Infant, Newborn and Infant, Low Birth Weight, run by NICHD Neonatal Research Network at 17 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 3 inclusion and 1 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 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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?

Feasibility of conducting a randomized trial (time frame: 1 year). 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 NCT01223261, which also lists 2 linked publications.

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 22 Mar 2019.

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