NCT02802761

Brief Summary

Study Cohort: All Children (Age: 3 months- 18 years, corrected age upto 2 years for preterm children) with Chronic Liver Disease attending Pediatric Hepatology Out Patient Department/In Patient Department

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

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, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

December 6, 2018

Status Verified

May 1, 2018

Enrollment Period

1.8 years

First QC Date

March 21, 2016

Last Update Submit

December 4, 2018

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

  • Reliability of SGNA versus nutritional status as assessed by standard anthropometric measures in children with chronic liver disease.

    Nutritional status (well nourished, moderate or severe malnutrition) of a child with chronic liver disease as assessed by standard anthropometric measures (weight, height, mid arm circumference, Body mass index, triceps and subscapular skin fold thickness) will be compared to the results of nutritional assessment score as obtained by applying Subjective Global Nutritional Assessment (SGNA) proforma.

    2 years

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All Children (Age: 3 months to 18 years, corrected age upto 2 years for preterm children) with CLD attending Pediatric Hepatology OPD/IPD.

You may qualify if:

  • Children from age of 3 months- 18 years (corrected age upto 2 years for preterm children)
  • Chronic liver disease.

You may not qualify if:

  • Any metabolic or endocrinal diseases independently affecting nutritional status
  • Refusal to give written informed consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Study Officials

  • Dr Seema Alam, MD

    Institute of Liver and Biliary Sciences

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2016

First Posted

June 16, 2016

Study Start

January 1, 2016

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

December 6, 2018

Record last verified: 2018-05

Locations

IN(1)