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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201710002618112 |
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Date of registration:
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12/09/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Probiotics use in A Neonatal unit in Port Sudan /Sudan: This combination is effective and should be part of the routine care.
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Scientific title:
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Use of Combined L. Acidophilus, L. Casei and L. Rhamnosus Solution In Preventing Morbiditie and Decrease Mortality In Sudan |
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Date of first enrolment:
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01/01/2014 |
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Target sample size:
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250 |
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Recruitment status: |
Complete |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2618 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Non-randomised
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Phase:
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Not Applicable
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Countries of recruitment
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Sudan
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Contacts
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Name:
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Ali Ahmad
Elsanousi |
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Address:
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King Salman hospital street
Riyadh
Saudi Arabia |
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Telephone:
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00966506444329 |
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Email:
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Elsanousi_ali@hotmail.com |
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Affiliation:
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consultant paediatrician and neonatologist at king Salman Hospital |
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Name:
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Mohammed
Bamugabil |
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Address:
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Tarab Hadal main street
531
Port Sudan
Sudan |
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Telephone:
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00249912341429 |
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Email:
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moh_bamg2@gmail.com |
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Affiliation:
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the hospital medical director |
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Key inclusion & exclusion criteria
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Inclusion criteria: preterm infants 26 to 37 wks of gestation, who were born or referred to our center during the stated period of the study
who started oral trophic feedings.
Exclusion criteria: severe congenital malformations,
GIT defects,
refusal of one/both parents.
Age minimum:
26 Week(s)
Age maximum:
37 Week(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neonatal Diseases
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Neonatal Diseases
Necrotising Enterocolitis, SEPSIS, Feeding intolerance, Nosocomial infection
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Necrotising Enterocolitis, SEPSIS, Feeding intolerance, Nosocomial infection
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Intervention(s)
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probiotane caps (three combined probiotics:L. rhamnosus, L. casei, L. acidophilus.
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the usual routine neonatal care
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Primary Outcome(s)
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Necrotising enterocolitis , sepsis, and death
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Secondary Outcome(s)
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feed intolerance, nosocomial infection, drug tolerability and side effect (s)
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Source(s) of Monetary Support
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Pharma trading Company
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the Revolving Drug Project /Red Sea State/ Sudan
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Ethics review
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Status: Approved
Approval date: 28/11/2013
Contact:
Dr Ebraheem Malik Alnasir
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Status: Approved
Approval date: 28/11/2013
Contact:
Dr Khalid Ahmadoan
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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