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CompletedNCT03805165jaundiceUpdated Dec 3, 2024

Associations of Nighttime Light Exposure During Pregnancy With Neonatal Jaundice:a Multi-centre Prospective Study in China

An observational study in Jaundice, Neonatal, sponsored by Guangdong Women and Children Hospital. Completed at 1 site in China. Open to participants aged 1 Day to 7 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-03.

Sponsored by Guangdong Women and Children Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
2,977
Ages
1 Day to 7 Days
Sex
All
01

Study summary

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

Read the detailed description

This was a multi-centre prospective study. All infants included were born in 8 hospitals in the southern, eastern, northern, western and central regions of mainland China in 2019. A total of 20839 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. The primary outcome was whether the neonate was diagnosed with hyperbilirubinemia within the first seven days of life. The effect of maternal nocturnal light exposure on neonate jaundice analyzed with lasso regression and random forest machine learning methods.

02

Conditions studied

  • Jaundice, Neonatal

Keywords

  • nighttime light exposure ,neonatal jaundice,China
03

Who can participate

Ages eligible
1 Day to 7 Days
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Inclusion criteria

gestational age more than 35 weeks(≥35) -

Exclusion criteria

Exclusion Criteria:

all kinds of congenital diseases, infants with pathologic jaundice

-

04

Study design

Observational model
Other
Time perspective
Other
Enrollment
2,977 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. Hour-specific Transcutaneous Bilirubin Level

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

    Time frame: 1 year

  2. 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

    Time frame: 2019

06

Study locations

1 site
  • Jie Yang
    Guangzhou, Guangdong 511442, China
07

Registry details

Key details

Study ID
NCT03805165
Lead sponsor
Guangdong Women and Children Hospital
Responsible party
yang jie (Director of neonatology of GuangdongWCH, Guangdong Women and Children Hospital) — Principal investigator
First posted
Jan 15, 2019
Start date
Feb 1, 2019
Primary completion
Mar 31, 2019
Completion
Dec 31, 2019
Last update
Dec 3, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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