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

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

Study Overview

• Status: Completed
• Conditions: Jaundice, Neonatal

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.

• Study Type: Observational
• Enrollment (Actual): 2977

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 511442
      • Jie Yang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 week (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

gestational age more than 35 weeks(≥35) -

Exclusion Criteria:

all kinds of congenital diseases, infants with pathologic jaundice

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Guangdong Women and Children Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: December 25, 2018
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: nighttime light exposure ，neonatal jaundice，China
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Hyperbilirubinemia; Skin Manifestations; Hyperbilirubinemia, Neonatal; Jaundice, Neonatal; Jaundice
• Other Study ID Numbers: Guangdong WCH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No