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Early Predictors of Necrotizing Enterocolitis in Neonates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03210831
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : November 13, 2018
Information provided by (Responsible Party):
Oluyinka O. Olutoye, MD PhD, Baylor College of Medicine

Brief Summary:
The goal of this project is to identify neonates who are predisposed to Necrotizing Enterocolitis (NEC). the investigators will determine the effectiveness of non-invasive measures as well as biochemical markers to identify neonates early in the disease process. Thus, the investigators aim to identify infants with NEC prior to the onset of symptoms to institute or test treatments in the long term to prevent the progression of the disease in these infants.

Condition or disease
Necrotizing Enterocolitis

Detailed Description:
The study will enroll premature, low birth weight infants in the Neonatal Intensive Care Units (NICU). Potential study subjects will be identified upon delivery, or transfer to the NICU, and notification by the neonatology service. Infants born at less than 30 weeks gestational age, birth weight less than or equal to 1500 grams will be eligible for enrollment in the study. The purpose of the study designed is to compare the splanchnic tissue oxygenation index and gut inflammatory biomarkers of patients with any stage of NEC with healthy controls. Since we will not be able to determine which patients will develop NEC a priori, we will anticipate enrolling up to 450 neonates to identify 15 neonates with NEC.

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Model for Early Predictors of Necrotizing Enterocolitis in Neonates
Actual Study Start Date : September 6, 2017
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. splanchnic tissue oxygenation in population at high risk for NEC [ Time Frame: 2022 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
low birth weight, preterm infants

Inclusion Criteria:

  • Infants born at ≤30 weeks gestational age and/or
  • Infants with a birth weight ≤1500 grams

Exclusion Criteria:

  • gestational age at birth greater than 30 weeks
  • obvious dysmorphic syndromes
  • any abdominal wall defect including omphalocele or gastroschisis
  • any known intestinal atresia
  • complex cardiac abnormalities
  • any known lethal chromosomal abnormalities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03210831

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Contact: Candace C Style, MD 832-822-0645

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United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Candace C Style, MD         
Sponsors and Collaborators
Baylor College of Medicine
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Responsible Party: Oluyinka O. Olutoye, MD PhD, Principal Investigator, Baylor College of Medicine Identifier: NCT03210831    
Other Study ID Numbers: H-34184
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: November 13, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oluyinka O. Olutoye, MD PhD, Baylor College of Medicine:
NEC, tissue oxygenation, gut inflammation
Additional relevant MeSH terms:
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Enterocolitis, Necrotizing
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases