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Is Primiparity a Risk Factor for Neonatal Hyperbilirubinemia?

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ClinicalTrials.gov Identifier: NCT03329040
Recruitment Status : Completed
First Posted : November 1, 2017
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Erez Nadir, MD, Hillel Yaffe Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Hyperbilirubinemia, Neonatal Other: No Intervention.

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.

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Study Type : Observational
Actual Enrollment : 4369 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Is Primiparity a Risk Factor for Neonatal Hyperbilirubinemia?
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : September 20, 2018
Actual Study Completion Date : September 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice

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.




Primary Outcome Measures :
  1. Length of stay of the infant [ Time Frame: 2 weeks ]
    Length of stay of the infant


Secondary Outcome Measures :
  1. Highest bilirubin level [ Time Frame: 2 weeks ]
    Highest bilirubin level

  2. Age at highest bilirubin level [ Time Frame: 2 weeks ]
    Age at highest bilirubin level



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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Infants who were born during one year, in a single medical center
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329040


Locations
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Israel
Hillel Yaffe medical center
H̱adera, Hadera, Israel, 38100
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
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Principal Investigator: Erez Nadir, MD Hillel Yaffe Medical Center

Additional Information:
Publications:
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Responsible Party: Erez Nadir, MD, Neonatologist, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT03329040     History of Changes
Other Study ID Numbers: 0090-17-HYMC-CTIL
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Unidentified data will be collected in an Excel workbook

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Erez Nadir, MD, Hillel Yaffe Medical Center:
Hyperbilirubinemia
Primiparity
multiparity

Additional relevant MeSH terms:
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Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Pathologic Processes
Infant, Newborn, Diseases