Late Neutropenia in VLBW Preterm Babies | NCT04217811

Studies
Late Neutropenia in VLBW Preterm Babies

NCT04217811

Sponsor

Hillel Yaffe Medical Center

Status

Completed

Last Update Posted

Aug 18, 2022Actual

Enrollment

237Actual

Phase

Not provided

Conditions

Neutropenia

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

Aug 2021

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, 2020Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Jan 2, 2020

First Submission Date that Met QC Criteria

Jan 2, 2020

First Posted Date

Jan 3, 2020Actual

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

Aug 17, 2022

Last Update Posted Date

Aug 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erez Nadir, MD, Principal investigator, Hillel Yaffe Medical CenterPrincipal Investigator

Lead Sponsor

Hillel Yaffe Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

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.

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

237Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Late neutropenia		Neutrophil count < 1500	Other: No intervention
No late neutropenia		Neutrophil count > 1500	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	Late neutropenia No late neutropenia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of stay	Number of days	2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Preterm infant with birth weight up to 1500 gram

Exclusion Criteria:

Early neutroenia - neutrophil count < 1500 at the first week

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

30 Days

Standard Ages

Child

Study Population

VLBW infants

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
9764892	Background	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.

ID	Term
D000380	Agranulocytosis
D007970	Leukopenia
D000095542	Cytopenia
D006402	Hematologic Diseases