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
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal

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

External Links

•   Risk factors