Protocol summary

Study aim
Evaluation and comparison of two probiotic drugs, Pedilact, Reuteflor and placebo, on the days of reaching full feeding volume , hospitalization days , days of need for oxygen therapy , daily weight gain , the incidence of necrotizing enterocolitis and neonatal jaundice in preterm neoates
Design
Clinical trial with control group, with parallel groups, triple blind, randomized, phase 3 on 90 patients
Settings and conduct
Neonatal intensive care unit of Valiasr Hospital in Birjand, the neonates are randomly divided into three groups of numbers and each group is prescribed 5 drops of Pedilact or Reuteflor or distilled water daily for 7 days.Lack of information of the patient and medical staff involved and responsible for data collection and data analyzer of the type of drug or placebo
Participants/Inclusion and exclusion criteria
Inclusion criteria: Premature neonates (gestational age less than 37 weeks) with age from birth to 7 days of age at the time of feeding start with a weight of 1000 to 2000 grams and non-inclusion conditions: severe asphyxia, cerebral hemorrhage, congenital anomaly major, Premature neonatal sepsis
Intervention groups
In each random group, preterm neonates are given 5 drops of the drug or placebo specific to that group for 7 days from the start of oral feeding.
Main outcome variables
Duration of hospitalization, time to Full enteral feeding, duration of oxygen therapy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210102049922N1
Registration date: 2021-06-11, 1400/03/21
Registration timing: prospective

Last update: 2021-06-11, 1400/03/21
Update count: 0
Registration date
2021-06-11, 1400/03/21
Registrant information
Name
Rana Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3162 2001
Email address
rezaeir9@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-15, 1400/03/25
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of probiotic drops pedilact and reuteflor in reducing prematurity complications in premature neonates
Public title
Comparison of the effects of different probiotics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature neonates (gestational age less than 37 weeks) aged from birth to 7 days of age were admitted at the time of feeding with a weight of 1000 to 2000 gr.
Exclusion criteria:
Severe asphyxia Intracerebral hemorrhage( ICH) Major congenital anomaly Early neonatal sepsis
Age
To 7 days old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
For each neonate eligible for the study, a lottery will done by using three different color cards in three sealed envelopes to randomly place the neonate in one of the three intervention groups. It will done by one of the parents and only the researcher knows the type of intervention based on the color of the card.Information of intervention and control groups inside the numbered envelope will be opaque and sealed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Lack of information of the patient and medical staff involved and responsible for data collection and data analyzer of the type of drug or placebo
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Ghafari Blvd.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2021-02-15, 1399/11/27
Ethics committee reference number
IR.BUMS.REC.1399.498

Health conditions studied

1

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

2

Description of health condition studied
Neonatal jaundice
ICD-10 code
P59.0
ICD-10 code description
Neonatal jaundice associated with preterm delivery

Primary outcomes

1

Description
Duration of hospitalization
Timepoint
Daily
Method of measurement
Calendar

2

Description
Time to full enteral feeding
Timepoint
Daily
Method of measurement
Calendar

3

Description
Duration of oxygen therapy
Timepoint
Daily
Method of measurement
Calendar

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group includes neonates who will receive 5 drops of probiotic Pedilact drops made by Iran Zist takhmir Company, daily with breast milk or formula for 7 days.
Category
Treatment - Drugs

2

Description
The second intervention group includes neonates who will receive 5 drops of probiotic Reuteflor made by Faradaroo fanavar mehr Iranian Company , daily with breast milk or formula for 7 days.
Category
Treatment - Drugs

3

Description
Control group:includes neonates who will receive 5 drops of distilled water daily with breast milk or formula for 7 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Mahmoudirad Alireza
Street address
Ghafari Blvd.
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3162 2001
Email
valiasr@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Kazemi Tooba
Street address
Ghafari Blvd.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Rezaei Rana
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Gafari Blvd.
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3162 2001
Email
rezaeir9@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Faal Gholamreza
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Valiasr Hospital, Gafari Blvd
City
Birjand
Province
South Khorasan
Postal code
971796415
Phone
+98 56 3162 2001
Email
rezaeir9@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Rezaei Rana
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Valiasr hospital.,Gaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3162 2001
Fax
Email
Rezaeir9@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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