Clinical trial NCT03329040: Is Primiparity a Risk Factor for Neonatal Hyperbilirubinemia?
Official title: Is Primiparity a Risk Factor for Neonatal Hyperbilirubinemia?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperbilirubinemia, Neonatal
Keywords: Hyperbilirubinemia
Primiparity
multiparity
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-11-01
Enrollment: 4369
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants who were born during one year, in a single 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.

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.

Eligibility 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)

Primary outcomes:
measure: Length of stay of the infant
timeFrame: 2 weeks
Secondary outcomes:
measure: Highest bilirubin level
timeFrame: 2 weeks
measure: Age at highest bilirubin level
timeFrame: 2 weeks
Other outcomes:
Locations:
city: H̱adera
country: Israel
facility: Hillel Yaffe medical center
state: Hadera
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Erez Nadir, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
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. doi: 10.1001/archinte.165.2.138.
citation: 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.