NCT04217811

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

January 2, 2020

Last Update Submit

August 17, 2022

Conditions

Neutropenia

Keywords

VLBWNeutropenia

Outcome Measures

Primary Outcomes (1)

  • Length of stay

    Number of days

    2 weeks

Study Arms (2)

Late neutropenia

Neutrophil count \< 1500

Other: No intervention

No late neutropenia

Neutrophil count \> 1500

Other: No intervention

Interventions

No interventionOTHER

No intervention

Late neutropeniaNo late neutropenia

Eligibility Criteria

AgeUp to 30 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

VLBW infants

You may qualify if:

  • Preterm infant with birth weight up to 1500 gram

You may not qualify if:

  • Early neutroenia - neutrophil count \< 1500 at the first week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe medical center

Hadera, Hadera, 38100, Israel

Location

Related Publications (1)

  • 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.

    PMID: 9764892BACKGROUND

MeSH Terms

Conditions

Neutropenia

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • Erez Nadir, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 2, 2020

First Posted

January 3, 2020

Study Start

January 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

August 18, 2022

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)