Protocol summary

Summary
The aim of this study is to determine the effect of oral probiotic on prevention of feeding intolerance in neonates under 1500 grams. This study is a double blind randomized clinical trial. sixty neonates with birth weigth of less than 1500 grams who need NICU care will enroll in the study. Neonates will be randomly allocated in two groups: Treatment and control. Neonates with gastrointestinal tract obstruction; congenital heart disease; congenitaL anomalies and death in first 72 hour of life and if mother receiving probiotic supplement and formula fed neonates will be excluded from the study. Neonates with inclusion criteria for study divided by two group of treatment and control by discharging white and yellow cards from closed bag. In treatment group, when feeding volume reaches to 5cc/kg/day, will receive 4 drop/day in neonates with weight of 1000-1500 grams and 2 drop/day in neonates with weight of less than 1000 grams and will add to breast milk and will order Q12hour and will continue until full feeding of neonates(120-160cc/kg/day). Routine treatment of background disease will accomplish in control group. Milk will increase 20-30 cc/kg day in every day. Feeding intolerance and NEC and their severity will be diagnosed according following criteria: stage one (suspected NEC): signs and symptoms consist of apnea, letargy, hematochezia, abdominal distention, temperature instability, gastric retention, without radiographic findings. stage two(documented NEC): signs of stage one plus thrombocytopenia with or without metabolic and respiratory acidosis, DIC, abdominal tenderness and existence of pneumatosis or gas in portal vein. stage three(advanced NEC): signs of stage two plus hypotension, bradycardia, sever apnea, respiratory and metabolic acidosis, DIC, clear abdominal tenderness, neutropenia and pneumoperitonitis. After data collection, abdominal distention, vomiting and gastric retention and time to enteral feeding and duration of hospitalization and death will compare between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015111925125N1
Registration date: 2016-01-18, 1394/10/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-01-18, 1394/10/28
Registrant information
Name
Alireza Yahyaee Shahandashti
Name of organization / entity
Chidrn's Hospital Amirkola
Country
Iran (Islamic Republic of)
Phone
+98 32353338
Email address
a.yahyaee@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research Technology Affairs, Babol University of Medical Sciences
Expected recruitment start date
2015-12-08, 1394/09/17
Expected recruitment end date
2016-04-22, 1395/02/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Probiotic effect on prevention of feeding intolerance in neonates under 1500 grams
Public title
Probiotic effect on prevention of feeding intolerance
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Neonates with birth weigth<1500 grams and admitted in NICU ward of Rohani hospital; Babol. Exclusion criteria: Neonates with obstruction of gastrointestinal tract; Congenital heart disease; Death in first 72 hour of life and if mother receiving probiotic supplement and Formula fed neonates.
Age
From 1 month old to 1 month 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
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Babol Univercity of Medical Sciences
Street address
Babol Univercity of Medical Sciences, Ganjafroz Street, Babol. Mazandaran, IR Iran.n
City
Babol
Postal code
4717647745
Approval date
2015-12-06, 1394/09/15
Ethics committee reference number
پ/ژ/30/6446

2

Ethics committee
Name of ethics committee
Babol Univercity of Medical Sciences
Street address
Babol Univercity of Medical Sciences, Ganjafroz Street, Babol, Mazandaran, IR Iran.
City
Babol
Postal code
4717647745
Approval date
2015-12-06, 1394/09/15
Ethics committee reference number
306446.ژ.پ

Health conditions studied

1

Description of health condition studied
Feeding intolerance
ICD-10 code
11
ICD-10 code description
Diseases of the Digestive system

Primary outcomes

1

Description
Feeding intolerance
Timepoint
During intervention
Method of measurement
During intervention

Secondary outcomes

1

Description
When full entral feeding is reached
Timepoint
During intervention
Method of measurement
During intervention

2

Description
When birth weight is reached
Timepoint
During intervention
Method of measurement
During intervention

Intervention groups

1

Description
Intervention group: When volume of feeding of neonate reaches to 5cc/kg/day, 2drop/12 h in neonates with birth weight of 1000-1500 grams and 1drop/12h in neonates with birth weight of less than 1000 grams of oral probiotics drop (Pedilact)Zist takhmir Pharmaceutics production will be administered until enteral fullfeeding time.
Category
Treatment - Drugs

2

Description
Controle group: Background disease treatment will accomplish and plasebo willnot administered.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rohani Hospital, Babol
Full name of responsible person
Alireza Yahyaee SHahandashti
Street address
Rohani Hospital, Keshavarz Street, Babol
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Babol University of Medical Sciences, Vice-Chancellor for reasearch Technology Affairs
Street address
Babol University of Medical Sciences, Ganjafroz Street, Babol. Mazandaran. IR Iran
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Amirkola Children's Hospital
Full name of responsible person
Alireza Yahyaee Shahandashti
Position
Neonatal Assistant
Other areas of specialty/work
Street address
Children's Hospital, Amirkola, Babol, Mazandaran. IR Iran
City
Babol
Postal code
4731741151
Phone
+98 11 3235 4951
Fax
+98 11 3234 0656
Email
A.YAHYAEE@MUBABOL.AC.IR
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Children's Hospital.Amirkola
Full name of responsible person
Yadollah Zahed Phasha
Position
Neonatologist
Other areas of specialty/work
Street address
Children's Hospital, Amirkola, Babol, Mazandaran, IR Iran
City
Babol
Postal code
4731741151
Phone
+98 11 3235 4951
Fax
+98 11 3234 0656
Email
zypasha@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Amirkola Children's Hospital
Full name of responsible person
Alireza Yahyaee Shahandashti
Position
Neonatal Assistant
Other areas of specialty/work
Street address
Children's Hospital, Amirkola, Babol, Mazandaran, IR Iran.
City
Babol
Postal code
4731741151
Phone
+98 11 3235 4951
Fax
+98 11 3234 0656
Email
A.YAHYAEE@MUBABOL.AC.IR
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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