A Genome-Wide Association Study for Neonatal Diseases
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ClinicalTrials.gov Identifier: NCT04074824 |
Recruitment Status :
Recruiting
First Posted : August 30, 2019
Last Update Posted : September 3, 2019
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Condition or disease |
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Neonatal Disease Necrotizing Enterocolitis |
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.
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 |

Group/Cohort |
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Non-NEC
Those without NEC
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NEC
Those with NEC
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- NEC [ Time Frame: First year ]Neonatal Disease

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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 |
Inclusion Criteria:
Chinese infants admitted in the neonatal unit (NNU)
Exclusion Criteria:
Refuse consent for study

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
Contact: Kathy Chan, Ph. D. | 852 3505 2858 | kathyyychan@cuhk.edu.hk |
Hong Kong | |
Prince of Wales Hospital | Recruiting |
Hong Kong, Hong Kong | |
Contact: Kathy Chan, Ph. D. 852 3505 2858 kathyyychan@cuhk.edu.hk |
Principal Investigator: | Kathy Chan, Ph. D. | CUHK |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Enterocolitis Enterocolitis, Necrotizing Infant, Newborn, Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |