NCT01482208

Brief Summary

Study will verify ability of infant Hydration Monitor (IHM) to assess changes of hydration status in newborns and infants by means of ultrasound velocity measurements through muscle tissues. Changes of tissue hydration will be followed during first days of life in newborns and in acute diarrhea in small children during re-hydration therapy. Weighting and clinical dehydration symptoms will be used as controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2011

Shorter than P25 for all trials

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

November 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 31, 2014

Status Verified

March 1, 2014

Enrollment Period

11 months

First QC Date

November 28, 2011

Last Update Submit

March 28, 2014

Conditions

DiarrheaDehydration

Keywords

DehydrationHydrationMuscle compositionDiarrheaPediatricsNeonatologyUltrasound

Outcome Measures

Primary Outcomes (1)

  • Assess the ability of IHM to measure changes of hydration status ni newborn and infants

    Infants and small children diagnosed with diarrhea or presenting to the hopsital with diseases known to cause dehydration are eligible

    1 week to several months

Eligibility Criteria

Age1 Day - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Newborns from 1 to 7 days Small children from 1 month to 3 years old

You may qualify if:

  • Newborns from 1 to 7 days old,
  • Health infants from 1 month to 3 years old,
  • Any ethnicity,
  • Male or female,
  • Infants with diarrhea,
  • Acute gastroenteritis,
  • Diarrhea and/or vomiting,
  • Suspected dehydration

You may not qualify if:

  • Congenital heart disease,
  • Renal failure,
  • Chronic liver disease,
  • Chronic lung disease,
  • Inflammatory bowel disease,
  • Immune deficiency,
  • Severe malnutrition,
  • Any external damage to skin of leg,
  • Infants and Children whose parents refuse permission to be included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children Clinical University Hospital (CCUH) of the Riga Stradinsh University (RSU)

Riga, LV-1004, Latvia

Location

Related Links

MeSH Terms

Conditions

DiarrheaDehydration

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic Processes

Study Officials

  • Dace Gardovska, Dr. Med.

    Head of Pediatrics, CCUH RSU

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 28, 2011

First Posted

November 30, 2011

Study Start

November 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

March 31, 2014

Record last verified: 2014-03

Locations

LA(1)