NCT03805165

Brief Summary

Make a neonatal jaundiced nomogram on Chinese jaundice data by joinning the major neonate centers all around China.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,977

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 25, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

December 25, 2018

Last Update Submit

November 28, 2024

Conditions

Jaundice, Neonatal

Keywords

nighttime light exposure ，neonatal jaundice，China

Outcome Measures

Primary Outcomes (2)

  • Hour-specific Transcutaneous Bilirubin Level

    make neonatal jaundiced nomogram base on the hour-specific transcutaneous bilirubin data

    1 year

  • whether the neonate was diagnosed with hyperbilirubinemia within the first seven days of life

    whether the neonate was diagnosed with hyperbilirubinemia within the first seven days of life

    2019

Study Arms (1)

neonate

transcutaneous bilirubin(TCB) measurements were performed with 2977 neonates at designated time points. The mean NTL exposure during pregnancy was respectively calculated based on each participant's residential address over the study course.

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Term and near term newborns, whos gestational age was more than 35 weeks(≥35)

You may qualify if:

  • gestational age more than 35 weeks(≥35) -

You may not qualify if:

  • all kinds of congenital diseases, infants with pathologic jaundice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jie Yang

Guangzhou, Guangdong, 511442, China

Location

MeSH Terms

Conditions

Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, NeonatalInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of neonatology of GuangdongWCH

Study Record Dates

First Submitted

December 25, 2018

First Posted

January 15, 2019

Study Start

February 1, 2019

Primary Completion

March 31, 2019

Study Completion

December 31, 2019

Last Updated

December 3, 2024

Record last verified: 2024-11

Locations

CN(1)