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Diagnosis of Ascites in Infants and Children (Ascites)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03341221
Recruitment Status : Unknown
Verified October 2017 by Asmaa abo bakr Ahmed, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : November 14, 2017
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Asmaa abo bakr Ahmed, Assiut University

Tracking Information
First Submitted Date October 28, 2017
First Posted Date November 14, 2017
Last Update Posted Date November 14, 2017
Estimated Study Start Date December 1, 2017
Estimated Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 10, 2017)
Diagnosis of ascites in infants and children with hepatic, cardiac, renal disease, tuberculosis and malignancy [ Time Frame: 1 year ]
Diagnosis of ascites in infants and children fromega age of 1month to 18 year
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnosis of Ascites in Infants and Children
Official Title Diagnosis of Ascites in Infants and Children
Brief Summary

Ascites is the pathologic accumulation of fluid within the peritoneal cavity. Causes of ascites in infants and children :hepatobiliary disorders,serositis, neoplasm, cardiac, genitourinary disorder, metabolic disease and others.

Diagnosis of ascites :history of abdominal distention, increasing weight, respiratory embarrassement, symptoms and signs of (hepatic ,cardiac,renal disease, tuberculosis and malignancy).

lnvestigation:complete blood count, complete urine examination, liver function tests, plasma proteins, renal function tests, clotting screen, tuberculin test, chest and abdominal plain films,abdominal ultrasound, upper gastrointestinal endoscopy, abdominal paracentesis for ascitic fluid analysis .

Detailed Description

Definition : Ascites is the pathologic fluid accumulation within the peritoneal cavity .

causes of ascites in infants and children :

  • Hepatobiliary disorders (cirrhosis, congenital hepatic fibrosis, acute hepatitis B,C ,Budd -chiari syndrome, Bile duct perforation)
  • Serositis (crohn's disease, eosinophilic enteropathy , Henoch- Shonlein purpura )
  • Neoplasm (lymphoma, wilm's tumor ,Glioma, Germ cell tumor, Ovarian tumor,mesothelioma, Neroblastoma )
  • Cardiac (Heart failure )
  • Metabolic disease
  • Gastrointestinal disorder (Nephrotic syndrome, peritoneal dialysis ). Diagnosis of ascites :History of abdominal distention, increasing weight, respiratory embarrassement, jaundice, bleeding (haematemsis, melena, and epistaxis ),Pruritus ,Growth failure ,abdominal pain, fever,Cyanosis, ,dyspnea during suckling, Orthopnea, Buffy eyes, lower limb swelling, Haematrruria .

By examination : Tachycardia ,Tachypnea ,Hypertension ,cyanosis, jaundice, clubbing of fingers ,limb edema ,Hepatomegaly, splenomegaly, dilated abdominal wall veins.

Investigations :

Laboratory tests :complete blood count , complete urine examination, liver function tests, plasma proteins, renal function tests, clotting screen, tuberculin test.

Imaging studies :chest and abdominal plain films, abdominal ultrasound, upper gastrointestinal endoscopy CT, MR I, Abdominal paracentesis for ascitic fluid analysis :cell count / cytology ,Gram 'stain and culture, Total proteins (albumin /globulin ratio ), Glucose, Amylase, lactase dehydrogenase, Triglycerides,Bilirubin.

Serum ascites albumin gradient (SAAG )is the best single test for classification of ascites into portal hypertensive (SAAG >1.1g/dl) and non-portal hypertensive (SAAG <1.1g/dl) causes.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Infants and children with ascites aged from 1month to 18 year
Condition Ascites
Intervention Not Provided
Study Groups/Cohorts One group
Diagnosis of ascites in infants and children by history, examination and investigations
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 10, 2017)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 1, 2018
Estimated Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • age from 1month to 18 year
  • infants and children with ascites (hepatic, cardiac, renal, malignant or tuberculous )
  • infants and children with peritonitis

Exclusion Criteria:

  • age <1month
  • surgical conditions as ruptured viscous or located abscess
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Month to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03341221
Other Study ID Numbers Assuit university 246810
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Asmaa abo bakr Ahmed, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date October 2017