NCT04013893

Brief Summary

The aim of this study was to evaluate the effect of calorie and enteral feeding timing on survival in critically ill children receiving inotropic, vasopressor and inodilatory supplements.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

July 8, 2019

Last Update Submit

July 10, 2019

Conditions

Critical IllnessEnteral Feeding Intolerance

Keywords

Enteral feedingvasopressorlactate

Outcome Measures

Primary Outcomes (1)

  • 28-d mortality

    To evaluate the effect of enteral feeding timing on survival

    28 days

Secondary Outcomes (2)

  • Lactate

    During inotropic treatment

  • Vasoactive inotrope score

    During inotropic treatment

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Critically ill children who have inotropic, vasopressor or inodilatory supplements without any problems and contraindications in gastrointestinal system functions

You may qualify if:

  • Children with normal gastrointestinal system function
  • Children receiving inotropic, vasopressor or inodilatory support

You may not qualify if:

  • Children with gastrointestinal system dysfunction
  • Children with enteral nutrition contraindicated
  • Children with metabolic disease with special nutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University, Division of Pediatric Intensive Care Unit

Adana, 01380, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dincer Yildizdaş, Professor

    Cukurova University Medicine Faculty

    STUDY CHAIR

Central Study Contacts

Ahmet Yöntem

CONTACT

+905075097709drayontem@gmail.com

Study Design

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

Study Record Dates

First Submitted

July 8, 2019

First Posted

July 10, 2019

Study Start

June 1, 2019

Primary Completion

January 1, 2020

Study Completion

June 1, 2020

Last Updated

July 12, 2019

Record last verified: 2019-07

Locations

TU(1)