Is Primiparity a Risk Factor for Neonatal Hyperbilirubine... | NCT03329040

Studies
Is Primiparity a Risk Factor for Neonatal Hyperbilirubinemia?

NCT03329040

Sponsor

Hillel Yaffe Medical Center

Status

Completed

Last Update Posted

Sep 21, 2018Actual

Enrollment

4,369Actual

Phase

Not provided

Conditions

Hyperbilirubinemia, Neonatal

Interventions

No Intervention.

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Sep 20, 2018Actual

Completion Date

Sep 20, 2018Actual

First Submitted Date

Oct 30, 2017

First Submission Date that Met QC Criteria

Oct 30, 2017

First Posted Date

Nov 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2018

Last Update Posted Date

Sep 21, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,369Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
No Intervention.	Other	No intervention.	Multipara mothers Primipara mothers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of stay of the infant	Length of stay of the infant	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Highest bilirubin level	Highest bilirubin level	2 weeks
Age at highest bilirubin level	Age at highest bilirubin level	2 weeks

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

14 Days

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erez Nadir, MD	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe medical center		Hadera	Hadera	38100	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28179382	Background	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.
15668358	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.

ID	Term
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D051556	Hyperbilirubinemia, Neonatal
D006932	Hyperbilirubinemia