Is Primiparity a Risk Factor for Neonatal Hyperbilirubinemia?

NCT03329040 | Completed DMC

• 1 other identifier: 0090-17-HYMC-CTIL
• Study Type: observational
• Target: 4,369
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperbilirubinemia, Neonatal

Keywords

Hyperbilirubinemia; Primiparity; multiparity

Outcome Measures

Primary Outcomes (1)

• Length of stay of the infant

  Length of stay of the infant

  2 weeks

Secondary Outcomes (2)

• Highest bilirubin level

  2 weeks

• Age at highest bilirubin level

  2 weeks

Study Arms (2)

Primipara mothers

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

Other: No Intervention.

Multipara mothers

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

Other: No Intervention.

Interventions

No Intervention. OTHER

No intervention.

Multipara mothers; Primipara mothers

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants who were born during one year, in a single medical center

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (1)

Hillel Yaffe medical center

Hadera, Hadera, 38100, Israel

Location

Related Publications (3)

• 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.

  PMID: 28179382 BACKGROUND

• 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.

  PMID: 15668358 BACKGROUND

• 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.

  PMID: 15231951 BACKGROUND

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Hyperbilirubinemia

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Erez Nadir, MD

  Hillel Yaffe Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 1, 2017
• Study Start: January 1, 2018
• Primary Completion: September 20, 2018
• Study Completion: September 20, 2018
• Last Updated: September 21, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)