Is Primiparity a Risk Factor for Neonatal Hyperbilirubinemia?

NCT ID: NCT03329040

Last Updated: 2018-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4369 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-09-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hyperbilirubinemia, Neonatal

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Primipara mothers

Infant to primipara mothers, i.e. the first infant to the mother - No intervention

No Intervention.

Intervention Type OTHER

No intervention.

Multipara mothers

Infant to multipara mothers, i.e. not the first infant to the mother - No intervention

No Intervention.

Intervention Type OTHER

No intervention.

Interventions

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No Intervention.

No intervention.

Intervention Type OTHER

Eligibility Criteria

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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)
Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Erez Nadir, MD

Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erez Nadir, MD

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center

Locations

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Hillel Yaffe medical center

Hadera, Hadera, Israel

Site Status

Countries

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Israel

References

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Amos RC, Jacob H, Leith W. Jaundice in newborn babies under 28 days: NICE guideline 2016 (CG98). Arch Dis Child Educ Pract Ed. 2017 Aug;102(4):207-209. doi: 10.1136/archdischild-2016-311556. Epub 2017 Feb 8. No abstract available.

Reference Type BACKGROUND
PMID: 28179382 (View on PubMed)

Brotman DJ, Walker E, Lauer MS, O'Brien RG. In search of fewer independent risk factors. Arch Intern Med. 2005 Jan 24;165(2):138-45. doi: 10.1001/archinte.165.2.138.

Reference Type BACKGROUND
PMID: 15668358 (View on PubMed)

American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics. 2004 Jul;114(1):297-316. doi: 10.1542/peds.114.1.297.

Reference Type BACKGROUND
PMID: 15231951 (View on PubMed)

Other Identifiers

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0090-17-HYMC-CTIL

Identifier Type: -

Identifier Source: org_study_id

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