Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201710002618112 Date of Registration: 12/09/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Probiotics use in A Neonatal unit in Port Sudan /Sudan: This combination is effective and should be part of the routine care.
Official scientific title Use of Combined L. Acidophilus, L. Casei and L. Rhamnosus Solution In Preventing Morbiditie and Decrease Mortality In Sudan
Brief summary describing the background and objectives of the trial Survival of preterm neonates resulted in a multitude of morbidities. One of the efforts to decrease this is the use of probiotics. Worldwide many investigators tested a probiotic or another. In the effort to reduce neonatal mortality in Sudan, the author tried three combined probiotics. To my knowledge, Worldwide nobody had tested such a combination, no such research in Sudan, or in the Arabic World at the moment. Objectives: The primary objective is to test effect on incidence of feeding intolerance, NEC, sepsis, and death in the study group, compared to the historical cohort of infants of same gestational age groups, not given probiotics. The secondary objective is to test drug tolerability, side effect, prevention of nosocomial infection, and length of hospitalization in the study group. Method: This is a pilot unicentral, longitudinal prospective, hospital ¿based study, included preterm infants 26 to 37 wks of gestation. Exclusion criteria: severe congenital malformations, GIT defects, refusal of one/both parents. 250,000,000 mixed bacterial unit is given orally, OD. Duration of treatment per infant was till maturity. 22 3 preterm infants were enrolled. Data analysed by SSPS 20 and manually
Type of trial CCT
Acronym (If the trial has an acronym then please provide) PUNS
Disease(s) or condition(s) being studied Necrotising Enterocolitis, SEPSIS, Feeding intolerance, Nosocomial infection,Neonatal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2014
Actual trial start date 01/01/2014
Anticipated date of last follow up 31/12/2016
Actual Last follow-up date 31/12/2016
Anticipated target sample size (number of participants) 250
Actual target sample size (number of participants) 223
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group the usual routine neonatal care no dose, it is the routine care, no specific intervention till maturity or death the usual neonatal routine care, incubator care, TPN, fluids, antibiotics, respiratory support. etc 76
Experimental Group probiotane caps (three combined probiotics:L. rhamnosus, L. casei, L. acidophilus. 250,000,000 bacterial units, OD (once a day) till maturity or death one capsule containing 2 billion bact. unit is dissolved in 8 ml DW or freshly expressed breast milk to yield 250,000,000 bacterial unit/ ml 223
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. severe congenital malformations, GIT defects, refusal of one/both parents. 26 Week(s) 37 Week(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/11/2013 Dr Ebraheem Malik Alnasir
Ethics Committee Address
Street address City Postal code Country
tarab hadal main street port Sudan 351 Sudan
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/11/2013 Dr Khalid Ahmadoan
Ethics Committee Address
Street address City Postal code Country
tarab hadal main street port Sudan 531 Sudan
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Necrotising enterocolitis , sepsis, and death every outcome is measured for each case at the time of discontinuing the drug, i.e maturity or death
Secondary Outcome feed intolerance, nosocomial infection, drug tolerability and side effect (s) every outcome is measured for each case at the time of discontinuing the drug, i.e maturity or death
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sea ports Corporation hospital/ Neonatal Unit tarab hadal main road Port Sudan 531 Sudan
FUNDING SOURCES
Name of source Street address City Postal code Country
Pharma trading Company Almashtal street Khartoum Sudan
the Revolving Drug Project /Red Sea State/ Sudan Alesbitalia street Port Sudan Sudan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pharma trading Company Almashtal street Port Sudan Sudan Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
sisters working at SPCH/ PORT SUDAN tarab hadal main streat Port Sudan 351 Sudan
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Suhair Othman soharia@hotmail.com 00249901920032 almatar main streat
City Postal code Country Position/Affiliation
Port Sudan 531 Sudan consultant paediatrician and neonatologist at SPC Hospital
Role Name Email Phone Street address
Public Enquiries Mohammed Bamugabil moh_bamg2@gmail.com 00249912341429 Tarab Hadal main street
City Postal code Country Position/Affiliation
Port Sudan 531 Sudan the hospital medical director
Role Name Email Phone Street address
Scientific Enquiries Ali Ahmad Elsanousi Elsanousi_ali@hotmail.com 00966506444329 King Salman hospital street
City Postal code Country Position/Affiliation
Riyadh Saudi Arabia consultant paediatrician and neonatologist at king Salman Hospital
REPORTING
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