Protocol summary

Summary
The aim of the study was to investigate Comparision of early and late human milk fortification on growth ,osteopenia and feeding tolerance in preterm newborns in shariati hospital from 2012- 2013. that Inclusion criteria: All pretem infants 28-34 weeks. Exclusion criteria: major congenital anomaly; emergency surjery (PDA ROP,...); infant hospitalize less 7 days ,infant transfer to other care system . This study includes 80 cases that divided on 2 groups of 40 infants 28-34 weeks thus during the study period was 6 weeks, birth weight ,height and head circumfrence, admision weight,Around the abdomen, bowel sounds, gastric lavage.NEC symptoms such as drowsiness, lethargy, biliary lavage, lavage more than 50% milk three hours, increased around abdominal of more than 2cm and stability than the previous feeding period of 6-4 hours and a clear blood in the stool as NEC onset of symptoms and NEC clinical and radiographic signs of disease are reviewed. Another group in the same group are considered as two sides Blind. At the end of the study the rate of weight, height and head circumfrence gain in 4 weeks age,serum calsum,serum phosphor,serum Alkalin phosphatase and serum vitamin -D measure in 6 weeks ago not and two groups are compared

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201301239568N4
Registration date: 2013-12-20, 1392/09/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-12-20, 1392/09/29
Registrant information
Name
Golnaz Rezaeizadeh
Name of organization / entity
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2357
Email address
mfnhrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-03-21, 1392/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of early and late human milk fortification on growth ,osteopenia and feeding tolerance in preterm newborns in shariati hospital from 2012- 2013.
Public title
Comparision of early and late human milk fortification on growth ,osteopenia and feeding tolerance in preterm newborns in shariati hospital from 2012- 2013.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All pretem infants 28-34 weeks Exclusion criteria: infants less 28 weeks and more 34 week; major congenital anomay; lemergency surjery (PDA ROP,...); infant hospitalize less 7 days; infant transfer to other care system
Age
From 28 years old to 34 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Comparision of early and late human milk fortification on growth ,osteopenia and feeding tolerance in preterm newborns in shariati hospital from 2012- 2013.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Ethics committee of Tehran University of Medical Sciences, 6 th floor of Tehran University of Medical Sciences, ghods St., Keshavarz blv, Tehran, Iran
City
Tehran
Postal code
14197
Approval date
2013-09-24, 1392/07/02
Ethics committee reference number
91-4-10-19451-94587

Health conditions studied

1

Description of health condition studied
weight gain
ICD-10 code
R62.8
ICD-10 code description
failure to weight gain

Primary outcomes

1

Description
Weight gain of infants
Timepoint
at birth, pre intervention and 4 weeks ago
Method of measurement
with digital scale

2

Description
osteopenia
Timepoint
6weeks ago
Method of measurement
serum calsum,serum phosphor,serum Alkalin phosphatase and serum vitamin -D measure

3

Description
po intolelance
Timepoint
Daily during the intervention
Method of measurement
Around the abdomen, bowel sounds, gastric lavage, fecal occult blood and full of feces

Secondary outcomes

1

Description
sepsis
Timepoint
Daily during the intervention
Method of measurement
phisical exam and labratory

2

Description
NEC
Timepoint
Daily during the intervention
Method of measurement
physical exam,labratory ,radiography

Intervention groups

1

Description
Intervention group: using fortifier, which is 3.6 gram sachet for25 ccmother milk .
Category
Prevention

2

Description
Control group:preterm infant late human milk fortification from 5o-100 cc/kg feeding
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr Negar Sajjadian
Street address
Shariati Hospital , north kargar blv,Tehran,IRan
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences/breast feeding reaserch
Full name of responsible person
Dr Mamc Shariat
Street address
Vaiasr hospital, Imam Khomeini Hospital complexex, Keshavarz blv, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences/breast feeding reaserch
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
Tehran University of Medical Sciences
Full name of responsible person
Dr Marzieh Asgharyan
Position
Resident of Pediatric
Other areas of specialty/work
Street address
Bahrami Hospital,kiaie blv,Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 7757 3797
Fax
Email
asgharyan_m@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Paymane Alizade
Position
Assistant Professor Of Neonatalogy /Daneshyar
Other areas of specialty/work
Street address
Bahrami Hospital,kiaie blv,Tehran,Iran
City
Tehran
Postal code
00982122782896
Phone
+98 21 2278 2896
Fax
Email
p.alizadet@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Marzieh Asgharyan
Position
Resident of Peditric
Other areas of specialty/work
Street address
Bahrami Hospital,kiaie blv,Tehran,Iran
City
Tehran
Postal code
00982177573797
Phone
+98 21 7757 3797
Fax
Email
asgharyan_m@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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