Hyperbilirubinemia, NeonatalNCT03329040
Is Primiparity a Risk Factor for Neonatal Hyperbilirubinemia?
An observational study of Hyperbilirubinemia, Neonatal, run by Hillel Yaffe Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Hyperbilirubinemia, Neonatal
- How many people
- 4,369 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2018to 20 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants who were born during one year, in a single medical center
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hyperbilirubinemia, Neonatal
- Being tested
- No Intervention.
- Keywords
- Hyperbilirubinemia, Primiparity, multiparity
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention.Other
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Primipara mothers | Infant to primipara mothers, i.e. the first infant to the mother - No intervention Receives: Other: No Intervention. | |
| Multipara mothers | Infant to multipara mothers, i.e. not the first infant to the mother - No intervention Receives: Other: No Intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay of the infant
Length of stay of the infant
Measured: 2 weeks
Secondary outcomes (2)
Highest bilirubin level
Highest bilirubin level
Measured: 2 weeks
Age at highest bilirubin level
Age at highest bilirubin level
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start1 Jan 2018
- Primary completion20 Sep 2018
- Study completion20 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hyperbilirubinemia, NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 4,369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erez Nadir, MD, Hillel Yaffe Medical Center
- Investigators
- Erez Nadir, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329040
- Sponsor's protocol ID
- 0090-17-HYMC-CTIL
- Status last verified
- Sep 2018
- First submitted
- 30 Oct 2017
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Unidentified data will be collected in an Excel workbook
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 28179382Brotman 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 15668358American 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.
PubMed 15231951
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Primiparity a Risk Factor for Neonatal Hyperbilirubinemia?
- ClinicalTrials.gov ID
- NCT03329040
- Acronym / sponsor ID
- 0090-17-HYMC-CTIL
- Conditions
- Hyperbilirubinemia, Neonatal
- Keywords
- Hyperbilirubinemia, Primiparity, multiparity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,369 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primipara mothers | – | Other: No Intervention.Infant to primipara mothers, i.e. the first infant to the mother - No intervention |
| Multipara mothers | – | Other: No Intervention.Infant to multipara mothers, i.e. not the first infant to the mother - No intervention |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants who were born during one year, in a single medical center
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention.No intervention. | Other | Multipara mothers, Primipara mothers |
Primary outcome
Length of stay of the infant
Time frame: 2 weeks
Length of stay of the infant
2 secondary outcomes
Highest bilirubin level
Time frame: 2 weeks
Age at highest bilirubin level
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Background: PubMed 28179382Amos 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.
- Background: PubMed 15668358Brotman 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.
- Background: PubMed 15231951American 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.
- Individual participant dataSharing planned: No. Unidentified data will be collected in an Excel workbook
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erez Nadir, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperbilirubinemia, Neonatal, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay of the infant (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03329040, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2018.