The Role and Effect of Anemia in Children With Pneumonia | NCT02466672

Studies
The Role and Effect of Anemia in Children With Pneumonia

NCT02466672

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Jul 25, 2019Actual

Enrollment

212Actual

Phase

Not provided

Conditions

Anemia
Pneumonia

Interventions

none - observational only

Countries

Uganda

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

ID	Type	Description	Link
5F32HL124951-03	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2019

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

Feb 2015

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Jun 3, 2015

First Submission Date that Met QC Criteria

Jun 4, 2015

First Posted Date

Jun 9, 2015Estimated

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

Jul 23, 2019

Last Update Posted Date

Jul 25, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter Moschovis, Postdoctoral Fellow, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
Mbarara University of Science and Technology	OTHER
Thrasher Research Fund	OTHER
National Institutes of Health (NIH)	NIH
National Heart, Lung, and Blood Institute (NHLBI)

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

212Actual

Name	Type	Description	Arm Group Labels	Other Names
none - observational only	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to recovery from pneumonia		participants will be followed for the duration of hospital stay, an expected average of 5 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 6 months to 59 months
WHO-defined severe pneumonia

Exclusion Criteria:

Congenital heart disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

59 Months

Standard Ages

Child

Study Population

Children age 6 months to 59 months admitted to the hospital with WHO-defined severe pneumonia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter P Moschovis, MD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mbarara University of Science and Technology		Mbarara			Uganda

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41921770	Derived	Moschovis PP, Sharfi A, Chaudhury S, Sharma A, Wiens MO, Kumbakumba E, Keneema O, Nyehengane D, Kabakyenga J, Ansermino JM, Kissoon N, Christiani DC, Dzik W, Kiwanuka JP, Hibberd PL. The Effect of Anemia on Mortality in Children Hospitalized with Severe Pneumonia in Uganda. J Pediatr. 2026 Jul;294:115090. doi: 10.1016/j.jpeds.2026.115090. Epub 2026 Mar 30.

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D012141	Respiratory Tract Infections
D007239	Infections