The aim of this study is evaluation of short term prognosis of enteral administration of fat emulsion (20% Esmoff) in very low birth weight infants.Three hundred and frothy five Very Low Birth Weight infants with birth weight of 700-1499 will be included.The Patients with negative blood culture in 48 hours of age will be chosen during 3 -5th days of birth.They will be divided randomly in three groups. One group of the patients will be received fat emulsion 20% (Esmof )between 3-5 days of age by intravenous route. Another group( case) will by receive by eternal form with same dose .Control group will not receive any type of fat emulsion. The dose of fat emulsion will be 1 gr/Kg/d and increase step by step to 3 gr/Kg/d . Daily wight gain ,increase of head circumference per week ,frequency of necrotizsing enterocolitis with grade 2 or more and mortality will be compare in 3 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201310164113N5
Registration date:2015-08-01, 1394/05/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-01, 1394/05/10
Registrant information
Name
Mohammad Bagher Hosseini
Name of organization / entity
Tabriz Universisty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
hossainm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Pediatric health research center of Tabriz University Of Medical Sceinces
Expected recruitment start date
2015-06-26, 1394/04/05
Expected recruitment end date
2015-12-26, 1394/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of intravenous v/s enteral administration of fat emulsion in very low birth weight infants
Public title
Evaluation of enteral administration of fat in very low birth weight infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Inborn Very Low Birth Weight infants in Alzahra Teaching Hospital; Birth Weight between 700-1499 gram; Appropriate for Gestational Age; without proven sepsis
Exclusion Criteria :
first blood culture positive( during 48 hours); Major congenital Anomalies; Nercotizing Entrocolitis; Direct Hyperbilirubinemia( Direct Bilirubin more than 2 Mg/dl and more than 15% of total Bilirubin ); Sever heart failure need treatment or Shock
Age
From 3 days old to 3 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University Of Medical Sceinces
Street address
Reseaech and Tecnology Chancelllor, Buidling 2, Golgasht St
City
Tabriz
Postal code
Approval date
2015-05-25, 1394/03/04
Ethics committee reference number
TBZMED.REC.1394.172
Health conditions studied
1
Description of health condition studied
prematurity
ICD-10 code
P07.2
ICD-10 code description
Less than 28 completed weeks (less than 196 completed days) of gestation.
Primary outcomes
1
Description
daily weight gain
Timepoint
From 3-5 days until3 weeks
Method of measurement
A digital scale with 1 gr sensivity
2
Description
Frequency of Necrotizing enterocolitis
Timepoint
From 3-5 days until discharge from hospital
Method of measurement
Aspirate more than 30% of previus feeding and the circomference of the belly more than 2 Cm with raidiologic findding
3
Description
Mortality rate
Timepoint
From 3-5 days until discharge from hospital
Method of measurement
evaluation of heart rate and respiration
4
Description
head circomference
Timepoint
From 3-5 days until discharge from hospital
Method of measurement
use of plastic tape with 1 CM accuracy
Secondary outcomes
1
Description
Frequency of proven sepsis
Timepoint
From 3-5 days until discharge from hospital
Method of measurement
Evaluation of clinical sign and CBC and CRP and Blood Culture
2
Description
Mean of serum triglycerid
Timepoint
From 3-5 days until 3 weeks
Method of measurement
mesuring serum triglycerid level by Selectra machin
3
Description
Frequency of feeding intolerance
Timepoint
From 3-5 days until 3 weeks
Method of measurement
Evaluation of GI aspitate before each feeding and finding more than 30% of previus one
4
Description
Frequency of Chronic Lung Disease
Timepoint
From 28 days until discharge from hospital
Method of measurement
Need of Oxygen or ventilatoey support
5
Description
Frequency of Retinopathy Of Prematurity
Timepoint
From 28 days until discharge from hospital
Method of measurement
Examination of the retin by indirect Retinoscopy
6
Description
Mean of hospitalization
Timepoint
From 3-5 days until discharge from hospital
Method of measurement
hospitalization recording sheet
7
Description
Frequency of Cholestasis
Timepoint
From 3-5 days until discharge from hospital
Method of measurement
Evaluation of Direct and Indirect Bilirubin level by Selectra Machin
Intervention groups
1
Description
In intervention group after tolerating the Minimal enteral feeding of breast milk we will start fat emulsion (Esmof20%) enteraly. Dose of Fat will be 1 gr/kg/d and will be increased step by step to 3 gr/kg/d.
Category
Treatment - Drugs
2
Description
In control group Fat emulsion will be given by intravenous rout. Dose of Fat will be 1 gr/kg/d and will be increased step by step to 3 gr/kg/d.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Teaching Hospital
Full name of responsible person
MohammadBagher Hosseini
Street address
Alzahra Hospital, Artesh Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Peiatric Health Research Center of Tabriz
Full name of responsible person
Mohammad Barzegar
Street address
Children Hospitalof Tabriz, Sheshgelan Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Peiatric Health Research Center of Tabriz
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sceinces
Full name of responsible person
Mohammad Bagher Hosseini
Position
Associate Professor
Other areas of specialty/work
Street address
Alzahra Hospital, Artesh Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
hossainm@tzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sceinces
Full name of responsible person
Mohammad Bagher Hosseini
Position
Associate Professor
Other areas of specialty/work
Street address
Alzahra Teaching Hospital, Artesh Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
hossainm@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Bagher Hosseini
Position
Associate Professor
Other areas of specialty/work
Street address
Neonatal Unit of Alzahra Teaching Hospital
City
Tabriz
Postal code
5165685783
Phone
+98 41 3335 0357
Fax
Email
hosseini.neo@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)