ClinicalTrials.gg
Sign In
CompletedNCT03329040Updated Sep 21, 2018

Is Primiparity a Risk Factor for Neonatal Hyperbilirubinemia?

An observational study in Hyperbilirubinemia, Neonatal, sponsored by Hillel Yaffe Medical Center. Completed at 1 site in Israel. Open to participants aged Up to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-21.

Sponsored by Hillel Yaffe Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
4,369
Ages
Up to 14 Days
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hyperbilirubinemia, Neonatal

Keywords

  • Hyperbilirubinemia
  • Primiparity
  • multiparity
03

In context

Hyperbilirubinemia, Neonatal

96 studies on the registry are indexed under Hyperbilirubinemia, Neonatal; 20 are open to participants now.

This study's enrollment of 4,369 is above the median of 300 across 31 observational studies indexed under Hyperbilirubinemia, Neonatal.

Browse Hyperbilirubinemia, Neonatal studies →

Lead sponsor

Hillel Yaffe Medical Center is the lead sponsor of 305 studies on the registry; 10 are open to participants now.

Browse Hillel Yaffe Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 14 Days
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
4,369 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherNo Intervention.

    No intervention.

06

What researchers measure

Primary outcomes

  1. Length of stay of the infant

    Length of stay of the infant

    Time frame: 2 weeks

Secondary outcomes

  1. Highest bilirubin level

    Highest bilirubin level

    Time frame: 2 weeks

  2. Age at highest bilirubin level

    Age at highest bilirubin level

    Time frame: 2 weeks

07

Study locations

1 site
  • Hillel Yaffe medical center
    H̱adera, Hadera 38100, Israel
08

References and documents

Publications

  • 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. PubMed 28179382 ↗
  • 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. PubMed 15668358 ↗
  • 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. Erratum In: Pediatrics. 2004 Oct;114(4):1138. PubMed 15231951 ↗

Individual participant data

Plan to share: No — Unidentified data will be collected in an Excel workbook

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Sep 2018, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 30, 2017
First posted
Nov 1, 2017
StartActual
Jan 1, 2018
Primary completionActual
Sep 20, 2018
CompletionActual
Sep 20, 2018
Last update
Sep 21, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03329040
Lead sponsor
Hillel Yaffe Medical Center
Responsible party
Erez Nadir, MD (Neonatologist, Hillel Yaffe Medical Center) — Principal investigator
First posted
Nov 1, 2017
Start date
Jan 1, 2018
Primary completion
Sep 20, 2018
Completion
Sep 20, 2018
Last update
Sep 21, 2018

Study contacts

Erez Nadir, MD
principal investigator · Hillel Yaffe Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hyperbilirubinemia, Neonatal →

Other studies from this sponsor

Hillel Yaffe Medical Center →

Start the discussion