NCT04102085

Brief Summary

The study aims to recruit eligible participants and conduct interviews, collect human milk samples, and conduct laboratory analysis of persistent organic pollutants' levels in human milk samples.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

September 25, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2021

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

2 years

First QC Date

September 23, 2019

Last Update Submit

December 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Amount of persistent organic pollutants in breast milk

    Approximately 30 types of persistent organic pollutants will be tested

    2 years

Study Arms (1)

Mothers under 30

no intervention will be administered

Other: no intervention

Interventions

no intervention

Mothers under 30

Eligibility Criteria

AgeUp to 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPrimiparae
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Fifty eligible participants (nursing mothers) will be identified during their postnatal visits at four selected Maternal Child Health Centres (MCHCs) of the Department of Health, representing four major regions in Hong Kong: Sai Ying Pun MCHC (Hong Kong Island); Kowloon City MCHC (Kowloon); Madam Yung Fung Shee MCHC (New Territories West); and Ma On Shan MCHC (New Territories East). If the recruitment is unsatisfactory in the above four centres, other MCHCs will be involved.

You may qualify if:

  • Primiparae;
  • years of age or below;
  • Have normal pregnancy;
  • Breastfeeding one infant only, and not multiple pregnancy;
  • Resided in Hong Kong for at least 10 years immediately before the date of interview;
  • Available for sample collection within 3 to 8 weeks of delivery; and
  • Both mother and child should be apparently healthy and free from any known infectious or other diseases (e.g. clinical hepatitis, AIDs, HIV).

You may not qualify if:

  • participants with previously diagnosed major diseases such as hepatitis, AIDS and other such diseases shall be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bonnie Kwok

Hong Kong, 000, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Breast milk

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast FeedingFeeding BehaviorBehavior

Study Officials

  • Lap Ah Tse

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 25, 2019

Study Start

September 25, 2019

Primary Completion

September 25, 2021

Study Completion

October 25, 2021

Last Updated

December 16, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations