Is Primiparity a Risk Factor for Neonatal Hyperbilirubinemia?

September 20, 2018 updated by: Erez Nadir, MD, Hillel Yaffe Medical Center
Neonatal hyperbilirubinemia elongates hospital stay and may require treatment. The investigators noticed that bilirubin levels were higher among infants of primipara mothers than among multipara mothers. As this data is dichotomic and easy to produce, and may influence the maintenance, the investigators decided to find out if primiparity is a risk factor for neonatal hyperbilirubinemia. The investigators intend to collect data from patient files during one year, and compare the bilirubin levels and length of stay between newborns to primipara mothers and multipara mothers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Neonatal hyperbilirubinemia elongates hospital stay and may require treatment. The investigators noticed that bilirubin levels were higher among infants of primipara mothers than among multipara mothers. As this data is dichotomic and easy to produce, and may influence the maintenance, the investigators decided to find out if primiparity is a risk factor for neonatal hyperbilirubinemia. The investigators intend to collect data from patient files during one year, and compare the bilirubin levels and length of stay between newborns to primipara mothers and multipara mothers.

Study Type

Observational

Enrollment (Actual)

4369

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Hadera
      • H̱adera, Hadera, Israel, 38100
        • Hillel Yaffe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 weeks (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants who were born during one year, in a single medical center

Description

Inclusion Criteria:

  • All infants that were born during one year in a single medical center and were transferred to well baby nursery, and were discharged from the well baby nursery.

Exclusion Criteria:

  • Infants who were transferred to neonatal intensive care unit due to any reason.
  • Infants whose mother could not take care of them (due to admission to intensive care unit, or due to adoption)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primipara mothers
Infant to primipara mothers, i.e. the first infant to the mother - No intervention
Other: No Intervention.
No intervention.
Multipara mothers
Infant to multipara mothers, i.e. not the first infant to the mother - No intervention
Other: No Intervention.
No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay of the infant
Time Frame: 2 weeks
Length of stay of the infant
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Highest bilirubin level
Time Frame: 2 weeks
Highest bilirubin level
2 weeks
Age at highest bilirubin level
Time Frame: 2 weeks
Age at highest bilirubin level
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

September 20, 2018

Study Completion (Actual)

September 20, 2018

Study Registration Dates

First Submitted

October 30, 2017

First Submitted That Met QC Criteria

October 30, 2017

First Posted (Actual)

November 1, 2017

Study Record Updates

Last Update Posted (Actual)

September 21, 2018

Last Update Submitted That Met QC Criteria

September 20, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0090-17-HYMC-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Unidentified data will be collected in an Excel workbook

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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