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A Genome-Wide Association Study for Neonatal Diseases

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.
 
ClinicalTrials.gov Identifier: NCT04074824
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Kathy Chan, Chinese University of Hong Kong

Brief Summary:
This is an observational study to identify genetic risks for neonatal diseases, necrotizing enterocolitis (NEC) using genome-wide association study (GWAS) and enterotype investigation. We hypothesize that specific genetic factors and microbiome could predispose preterm neonates for the development of NEC.

Condition or disease
Neonatal Disease Necrotizing Enterocolitis

Detailed Description:

NEC is the most frequently encountered surgical emergencies and a life-threatening disease that predominantly affects preterm neonates. The incidence is estimated to be 7-10% in ver low birth weight (VLBW) neonates (Lin and Stoll, 2006; Neu and Walker, 2011). However, a significant proportion of affected neonates (20-30%) develops severe progressive disease with intestinal necrosis and complications resulting in gut perforation and peritonitis which require urgent surgical intervention (surgical cases) (Sharma et al., 2006). The mortality rate of surgical cases is high (25-50%), and may increase to 100% in patients with pan-necrosis of the bowel. Those neonates who survived often suffer severe morbidity, including short bowel syndrome, parenteral nutrition-associated cholestasis, poor physical growth and neurodevelopmental impairment (Neu and Walker, 2011; Salhab et al., 2004). However, the etiology and pathophysiology of NEC remain incompletely understood. The current knowledge has directed towards multiple predisposing factors which include prematurity, immature gut mucosa and host defense immunity, formula milk feeding and altered microbial colonization in the gut resulting in excessive inflammatory response, leading to irreversible intestinal cell death and gut necrosis (Neu and Walker, 2011; Chan et al., 2013). To date, no genetic risk markers or biomarkers are available for reliable prediction of neonates who are at high risk of developing NEC. Besides host genetic factors, gut bacteria have been reported to predispose neonates to disease risk (Mai et. al., 2011; Neu and Pammi, 2018).

In this study, we shall conduct a GWAS on Chinese preterm neonates for identification of genetic risks for NEC and determine gut microbiome structure (enterotype) of NEC.

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Study Type : Observational
Estimated Enrollment : 310 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Genome-Wide Association Study on Chinese Preterm Neonates and Identification of Functional Variants for Susceptibility to Necrotising Enterocolitis
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Non-NEC
Those without NEC
NEC
Those with NEC



Primary Outcome Measures :
  1. NEC [ Time Frame: First year ]
    Neonatal Disease



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Chinese infants
Criteria

Inclusion Criteria:

Chinese infants admitted in the neonatal unit (NNU)

Exclusion Criteria:

Refuse consent for study


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 ClinicalTrials.gov identifier (NCT number): NCT04074824


Contacts
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Contact: Kathy Chan, Ph. D. 852 3505 2858 kathyyychan@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Kathy Chan, Ph. D.    852 3505 2858    kathyyychan@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Kathy Chan, Ph. D. CUHK
Publications:
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Responsible Party: Kathy Chan, Scientific Officer, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04074824    
Other Study ID Numbers: 2017.493
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Infant, Newborn, Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases