Protocol summary

Summary
The aim of this study is to determine the effect of oral probiotics in prevention of necrotizing enterocolitis in premature neonates. This study is a double blind randomized controlled trial. Fifty premature neonates with gestational age of less than 36 weeks and birth weight of 1000-2500 gr who need NICU care will enroll in the study. Neonates with gasterointestinal obstruction, congenital heart diseases, omphalocele, gasterochesia, asphyxia (grades II or III) and maternal addiction will be excluded from the study. Neonates will be randomly allocated in two groups: Treatment and placebo. The treatment group, when milk volume reaches to 5 cc/kg/day, will receive 1 drop/kg of oral probiotic (diluted to 0.5 ml with normal saline) each 12 hours. The placebo group will receive 0.5 ml normal saline each 12 hours. The drug and placebo which are prepared in similar syringes will be administered by a nurse, trained before the study. NEC and its severity will be diagnosed according to the following criteria: Stage I(suspected NEC): apnea, lethargy, hematochezia, abdominal distention, temperature instability, gastric retention, without radiographic findings. Stage II (documented NEC): signs of stage I plus thrombocytopenia with or without mild metabolic acidosis, abdominal tenderness, pneumatosis or gas in portal vein. Stage III (advanced NEC): signs of stage II plus hypotension, bradycardia, severe apnea, respiratory and metabolic acidosis, DIC, abdominal tenderness, neutropenia, pneumoperitonitis. After data collection, necrotizing enterocolitis, time to full enteral feeding and duration of hospitalization were compared between two groups .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014022716574N3
Registration date: 2014-05-24, 1393/03/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-05-24, 1393/03/03
Registrant information
Name
Fatemeh Naghibifard
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1726 2871
Email address
dr_naghibifard@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral probiotics in prevention of necrotizing enterocolitis in premature neonates.
Public title
The effect of probiotics in prevention of necrotizing enterocolitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Neonates with gestational age <36 weeks; Birth weight 1000-2500 grams and admitted in NICU ward of the Shahid Sadughi hospital; Yazd Exclusion criteria: Neonates with obstruction of gasterointestinal; Congenital heart disease; Omphalocele; Gasterochesia; Asphyxia (grade II,III)and Addiction of mother.
Age
From 1 day old to 3 months old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Ethical Committee of Shahid Sadoughi Univercity of Medical Sciences
Street address
Bahonar Square
City
Yazd
Postal code
8915845354
Approval date
2014-03-08, 1392/12/17
Ethics committee reference number
257428/1/17

Health conditions studied

1

Description of health condition studied
Necrotizing enterocolitis
ICD-10 code
P77
ICD-10 code description
Necrotizing enterocolitis of fetus and newborn

Primary outcomes

1

Description
Necrotizing enterocolitis
Timepoint
During intervention
Method of measurement
Bell staging criteria

Secondary outcomes

1

Description
When full enteral feeding is reached
Timepoint
During intervention
Method of measurement
Per day

2

Description
Weight of neonate at the time of discharged
Timepoint
When the neonate is discharged
Method of measurement
With scale(seca)

3

Description
During hospitalization
Timepoint
When the neonate is discharged
Method of measurement
Per day

4

Description
Mortality
Timepoint
During intervention
Method of measurement
Per person

Intervention groups

1

Description
Intervention group: When volume of feeding reaches to 5cc/kg/day, 1 drop/kg of oral probiotics drop (Pedilact, Sepehr Pharmaceutics, Iran) diluted with normal saline to 0.5cc will be administered each 12 hours.
Category
Prevention

2

Description
Control group: 0.5 cc of normal saline (Samen Pharmaceutics, Iran) will be administered each 12 hours when volume feeding reaches to 5 cc/kg/day.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Fateme Naghibifard
Street address
Shahid Sadoughi Hospital, Shahid Ghandi Avenue, Yazd
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Fateme Ezodini
Street address
Bahonar Square, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Shahid Sadoughi 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
Shahid Sadoughi Hospital
Full name of responsible person
Fateme Naghibifard
Position
Pediatric resident
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital, Shahid Ghandi Avenue, Yazd
City
Yazd
Postal code
8916886938
Phone
+98 35 1822 4000
Fax
+98 35 1822 4100
Email
Naghibifard_128@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr.Mahmood Noorishadkam
Position
Neonatologist
Other areas of specialty/work
Street address
Bahonar Square, Yazd
City
Yazd
Postal code
8916886938
Phone
+98 35 1822 4000
Fax
+98 35 1822 4100
Email
Noorishadkam@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi Hospital
Full name of responsible person
Fateme Naghibifard
Position
Pediatric resident
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital, Shahid Ghandi Avenue, Yazd
City
Yazd
Postal code
8916886938
Phone
+98 35 1822 4000
Fax
+98 35 1822 4100
Email
Naghibifard_128@yahoo.com
Web page address
www.ssu.ac.ir

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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