NCT02698683

Brief Summary

Participants were classified as normal or malnourished according to anthropometric measures. Serum albumin and zinc were recovered on the 1st and 7th days of hospitalization. Lymphocyte count was also recorded on the 1st and 7th days.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2014

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

February 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
Last Updated

March 4, 2016

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

February 22, 2016

Last Update Submit

February 29, 2016

Conditions

Lymphopenia

Keywords

NutritionLymphocyte CountImmunoparalysisnutritional status of septic patients

Outcome Measures

Primary Outcomes (1)

  • presence of lymphopenia

    seven days

Study Arms (2)

malnourished

low zinc, low albumin, anthropometric measures lower than percentile 5 lymphocyte count

Other: lymphocyte count

well nourished

normal zinc, normal albumin, anthropometric measures higher than percentile 5 lymphocyte count

Other: lymphocyte count

Interventions

lymphocyte countOTHER

lymphocyte count

malnourishedwell nourished

Eligibility Criteria

Age1 Month - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

pediatric septic patients

You may qualify if:

  • septic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Delgado AF, Okay TS, Leone C, Nichols B, Del Negro GM, Vaz FA. Hospital malnutrition and inflammatory response in critically ill children and adolescents admitted to a tertiary intensive care unit. Clinics (Sao Paulo). 2008 Jun;63(3):357-62. doi: 10.1590/s1807-59322008000300012.

    PMID: 18568246RESULT

  • Manzoli TF, Delgado AF, Troster EJ, de Carvalho WB, Antunes AC, Marques DM, Zamberlan P. Lymphocyte count as a sign of immunoparalysis and its correlation with nutritional status in pediatric intensive care patients with sepsis: A pilot study. Clinics (Sao Paulo). 2016 Nov 1;71(11):644-649. doi: 10.6061/clinics/2016(11)05.

    PMID: 27982165DERIVED

MeSH Terms

Conditions

Lymphopenia

Interventions

Lymphocyte Count

Condition Hierarchy (Ancestors)

LeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Leukocyte CountBlood Cell CountCell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 4, 2016

Study Start

February 1, 2014

Primary Completion

June 1, 2015

Study Completion

January 1, 2016

Last Updated

March 4, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

there is no plan to share data