1. Home
  2. Approved trials
  3. » فارسی

The effect of probiotics in premature newborn infants in the NICU and neonatal wards at Vali-Asr hospital year 1391

Protocol summary

Summary
The aim of the study was to evaluate the effect of probiotics in premature newborn that Inclusion criteria: All infants below 2000 grams and over 750 grams and infants less than 37 weeks . Exclusion criteria: infants under 2000 grams, 750 grams and above, family immunodeficiency, congenital heart disease. After a group of stable vital signs and starting with minimal entral feeding to 1-8 / 0 g per day in divided doses with each feeding in the first 10 days after birth Sashە Protexin Powder 1 gram daily for 7 days or more is prescribed.Around the abdomen, bowel sounds, gastric lavage, fecal occult blood and full of feces daily, weigh daily, weekly head circumference, height and time to milk at 120-150 cc / kg / day,NEC symptoms such as drowsiness, lethargy, biliary lavage, lavage more than 50% milk three hours, increased abdominal girth 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.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201210209568N3
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
2012-06-21, 1391/04/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotics in premature newborn infants in the NICU and neonatal wards at Vali-Asr hospital year 1391
Public title
The effect of probiotics in premature newborn
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: All infants below 2000 grams and over 750 grams and infants less than 37 weeks Exclusion criteria: infants under 2000 grams, 750 grams and above, family immunodeficiency, congenital heart disease
Age
To 37 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

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
1419733141
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
91-03-91-19454-96454-96819

Health conditions studied

1

Description of health condition studied
Weight Gain
ICD-10 code
p92.9
ICD-10 code description
feeding problem of newborn

Primary outcomes

1

Description
feeding
Timepoint
under observation
Method of measurement
observation

Secondary outcomes

1

Description
NEC
Timepoint
Under Observation
Method of measurement
Observation-clinical exam

Intervention groups

1

Description
Intervention group: using Proxtin powder, which is a probiotic substance, 1 gram sachet for 7 days in the first 10 days after birth
Category
Lifestyle

2

Description
Control group: no use of 1 gram powder sachet proxtin the first 10 days of birth
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
samane sedghi
Street address
Vaiasr hospital,Imam Khomeini Hospital complexex, Keshavarz blv,14914, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences
Full name of responsible person
Mamak 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
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences
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
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
samane sedghi
Position
researcher/MD
Other areas of specialty/work
Street address
Vaiasr hospital,Imam Khomeini Hospital complexex, Keshavarz blv, Tehran, Iran
City
Tehran
Postal code
14197
Phone
+98 21 6659 1316
Fax
+98 21 6659 1315
Email
samanesedghi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Maternal Fetal Neonatarch Center,Tehran University of Medical Sciencl Reseaes
Full name of responsible person
Ehahe Amini
Position
professor/neonatologist
Other areas of specialty/work
Street address
Vaiasr hospital,Imam Khomeini Hospital complexex, Keshavarz blv, Tehran, Iran
City
Tehran
Postal code
14197
Phone
+98 21 6659 1316
Fax
+98 21 6659 1315
Email
amini_el88@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences
Full name of responsible person
Samane Sedghi
Position
researcher/MD
Other areas of specialty/work
Street address
Vaiasr hospital,Imam Khomeini Hospital complexex, Keshavarz blv, Tehran, Iran
City
Tehran
Postal code
14197
Phone
+98 21 6659 1316
Fax
+98 21 6659 1315
Email
samanesedghi@gmail.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
Loading...