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NCT03329040 Clinical Trial

Is Primiparity a Risk Factor for Neonatal Hyperbilirubinemia?

Hyperbilirubinemia, Neonatal Clinical Trial

Official title:
Is Primiparity a Risk Factor for Neonatal Hyperbilirubinemia?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03329040
Other study ID # 0090-17-HYMC-CTIL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date September 20, 2018

Study information
Verified date September 2018
Source Hillel Yaffe Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 4369
Est. completion date September 20, 2018
Est. primary completion date September 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 14 Days
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• No Intervention.
No intervention.

Locations
Country Name City State
Israel Hillel Yaffe medical center H_adera Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. Erratum in: Pediatrics. 2004 Oct;114(4):1138. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Length of stay of the infant Length of stay of the infant 2 weeks
Secondary Highest bilirubin level Highest bilirubin level 2 weeks
Secondary Age at highest bilirubin level Age at highest bilirubin level 2 weeks
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