NeutropeniaNCT04217811
Late Neutropenia in VLBW Preterm Babies
An observational study of Neutropenia, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
There are rare reports regarding late neutropenua in very low birth weight preterm infants. The investigators wish to characterize it among our population, and assess its consequenses and the postnatal menagement of the infants. Read more about this study
- Who is it for?
- Ages Up to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Neutropenia
- How many people
- 237 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2020to 31 Dec 2021
- 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 30 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: VLBW infants
Who may be able to join
- Preterm infant with birth weight up to 1500 gram
Who cannot join
- Early neutroenia - neutrophil count < 1500 at the first week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Late Neutropenia in VLBW Preterm Babies - Characterization and Post Natal Menagement
There are rare reports regarding late neutropenua in very low birth weight preterm infants.
The investigators wish to characterize it among our population, and assess its consequenses and the postnatal menagement of the infants.
Read the detailed description
There are rare reports regarding late neutropenua in very low birth weight preterm infants.
The investigators wish to characterize it among our population, and assess its consequenses and the postnatal menagement of the infants.
- Conditions
- Neutropenia
- Being tested
- No intervention
- Keywords
- VLBW, Neutropenia
- Medical subject headings
- Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Late neutropenia | Neutrophil count < 1500 Receives: Other: No intervention | |
| No late neutropenia | Neutrophil count > 1500 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Number of days
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 posted3 Jan 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeutropeniaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 237 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
- NCT04217811
- Sponsor's protocol ID
- 0160-19-HYMC
- Status last verified
- Aug 2021
- First submitted
- 2 Jan 2020
- Last updated
- 18 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Juul SE, Calhoun DA, Christensen RD. "Idiopathic neutropenia" in very low birthweight infants. Acta Paediatr. 1998 Sep;87(9):963-8. doi: 10.1080/080352598750031635.
PubMed 9764892
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Neutropenia in VLBW Preterm Babies - Characterization and Post Natal Menagement
- ClinicalTrials.gov ID
- NCT04217811
- Acronym / sponsor ID
- 0160-19-HYMC
- Conditions
- Neutropenia
- Keywords
- VLBW, Neutropenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 3 Jan 2020 (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.
There are rare reports regarding late neutropenua in very low birth weight preterm infants.
The investigators wish to characterize it among our population, and assess its consequenses and the postnatal menagement of the infants.
Detailed description
There are rare reports regarding late neutropenua in very low birth weight preterm infants.
The investigators wish to characterize it among our population, and assess its consequenses and the postnatal menagement of the infants.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Late neutropenia | – | Other: No interventionNeutrophil count < 1500 |
| No late neutropenia | – | Other: No interventionNeutrophil count > 1500 |
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- VLBW infants
Key inclusion criteria (1 listed)
- Preterm infant with birth weight up to 1500 gram
Key exclusion criteria (1 listed)
- Early neutroenia - neutrophil count < 1500 at the first week
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 interventionNo intervention | Other | Late neutropenia, No late neutropenia |
Primary outcome
Length of stay
Time frame: 2 weeks
Number of days
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 18 Aug 2022.
- Background: PubMed 9764892Juul SE, Calhoun DA, Christensen RD. "Idiopathic neutropenia" in very low birthweight infants. Acta Paediatr. 1998 Sep;87(9):963-8. doi: 10.1080/080352598750031635.
- Individual participant dataSharing planned: No
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Suspected Neutropenic Fever, Confirmed Neutropenic Fever
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 Neutropenia, 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 1 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 18 Aug 2022. 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 (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 NCT04217811, which also lists 1 linked publication.
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 18 Aug 2022.