NCT04074824

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Sep 2018Oct 2026

Study Start

First participant enrolled

September 1, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2019

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

8.2 years

First QC Date

August 29, 2019

Last Update Submit

June 17, 2025

Conditions

Neonatal DiseaseNecrotizing Enterocolitis

Outcome Measures

Primary Outcomes (1)

  • NEC

    Neonatal Disease

    First year

Study Arms (2)

Necrotizing enterocolitis

Neonates diagnosed with NEC based on the Modified Bell criteria for NEC including clinical, radiological and Laboratory findings.

Non-NEC

Neonates diagnosed with other conditions including low birthweight, prematurity, infection, metabolic, cardiovascular, CNS, respiratory or gastrointestinal problems.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chinese infants

You may qualify if:

  • Chinese infants admitted in the neonatal unit (NNU)

You may not qualify if:

  • Refuse consent for study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (7)

  • Lin PW, Stoll BJ. Necrotising enterocolitis. Lancet. 2006 Oct 7;368(9543):1271-83. doi: 10.1016/S0140-6736(06)69525-1.

    PMID: 17027734BACKGROUND

  • Neu J, Walker WA. Necrotizing enterocolitis. N Engl J Med. 2011 Jan 20;364(3):255-64. doi: 10.1056/NEJMra1005408. No abstract available.

    PMID: 21247316BACKGROUND

  • Sharma R, Hudak ML, Tepas JJ 3rd, Wludyka PS, Marvin WJ, Bradshaw JA, Pieper P. Impact of gestational age on the clinical presentation and surgical outcome of necrotizing enterocolitis. J Perinatol. 2006 Jun;26(6):342-7. doi: 10.1038/sj.jp.7211510.

    PMID: 16724075BACKGROUND

  • Salhab WA, Perlman JM, Silver L, Sue Broyles R. Necrotizing enterocolitis and neurodevelopmental outcome in extremely low birth weight infants <1000 g. J Perinatol. 2004 Sep;24(9):534-40. doi: 10.1038/sj.jp.7211165.

    PMID: 15254558BACKGROUND

  • Chan KY, Leung KT, Tam YH, Lam HS, Cheung HM, Ma TP, Lee KH, To KF, Li K, Ng PC. Genome-wide expression profiles of necrotizing enterocolitis versus spontaneous intestinal perforation in human intestinal tissues: dysregulation of functional pathways. Ann Surg. 2014 Dec;260(6):1128-37. doi: 10.1097/SLA.0000000000000374.

    PMID: 24368664BACKGROUND

  • Mai V, Young CM, Ukhanova M, Wang X, Sun Y, Casella G, Theriaque D, Li N, Sharma R, Hudak M, Neu J. Fecal microbiota in premature infants prior to necrotizing enterocolitis. PLoS One. 2011;6(6):e20647. doi: 10.1371/journal.pone.0020647. Epub 2011 Jun 6.

    PMID: 21674011BACKGROUND

  • Neu J, Pammi M. Necrotizing enterocolitis: The intestinal microbiome, metabolome and inflammatory mediators. Semin Fetal Neonatal Med. 2018 Dec;23(6):400-405. doi: 10.1016/j.siny.2018.08.001. Epub 2018 Aug 17.

    PMID: 30172660BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Buccal swabs and fecal samples

MeSH Terms

Conditions

Infant, Newborn, DiseasesEnterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesEnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Kathy Chan, Ph. D.

    CUHK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Officer

Study Record Dates

First Submitted

August 29, 2019

First Posted

August 30, 2019

Study Start

September 1, 2018

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

June 18, 2025

Record last verified: 2025-06

Locations

HK(1)