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Trial registered on ANZCTR


Registration number
ACTRN12620000538943
Ethics application status
Approved
Date submitted
19/01/2020
Date registered
1/05/2020
Date last updated
13/09/2021
Date data sharing statement initially provided
1/05/2020
Date results information initially provided
13/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of probiotic on the weight gaining and feeding intolerance in preterm newborn babies of Kabul city via a randomized clinical trial
Scientific title
The effect of dual strain probiotic on the growth and feeding intolerance in premature neonates of Kabul city: A randomized clinical trial

Secondary ID [1] 300302 0
‘Nil known’
Universal Trial Number (UTN)
U1111-1246-9164
Trial acronym
EPGFPNT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prematurity 315900 0
Low birth weight 315901 0
slow weight gaining 315902 0
Condition category
Condition code
Diet and Nutrition 314174 314174 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 315424 315424 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A or study group : In this group neonates will feed by mother breast milk together with Gutcare ( dual strain probiotic, a product of Searle, Pakistan) that each sachet containing 500mg Bifidobacterium and Clostridium butyricum, ( (1gr contain 12billion cfu so 500mg has 6 billion cfu). The half sachet (250mg) dissolved in 1-3ml milk and administrated orally twice daily. The probiotic-fortified milk will start from day 4 and continue for at least two weeks.
The routine management such as incubator care, fluid and electrolyte maintenance, Expressed Breast Milk (EBM) and premature formula via NGT for infants less than 1800gr or gestational age equal or less than 35weeks will undertake for two mentioned groups. EBM will initiates as trophic feeds of 10 to 20 mL/kg/day at 2 hourly interval in hemodynamically stable infants. Feeds will advance by 20 mL/kg/day up to 150ml/kg/day.
Intervention code [1] 316577 0
Treatment: Other
Comparator / control treatment
Group B or the control group: in this group non-probiotic fortified mother breast-feeding is the choice.
The routine management such as incubator care, fluid and electrolyte maintenance, Expressed Breast Milk (EBM) and premature formula via NGT for infants less than 1800gr or gestational age equal or less than 35weeks will undertake for two mentioned groups. EBM will initiates as trophic feeds of 10 to 20 mL/kg/day at 2 hourly interval in hemodynamically stable infants. Feeds will advance by 20 mL/kg/day up to 150ml/kg/day.
Control group
Active

Outcomes
Primary outcome [1] 322554 0
Daily weight gain would determined as grams by an accurate digital balance.

Timepoint [1] 322554 0
For three weeks
Primary outcome [2] 322555 0
feeding intolerance accepted as two or more episodes of vomiting during last 6hr or developed prominent abdominal distension. The daily number of such episodes would be noted for every neonates.
Timepoint [2] 322555 0
during the three week of observation.
Secondary outcome [1] 378923 0
neonatal death during hospital stay would be find via medical record.
Timepoint [1] 378923 0
Percentage of neonatal death during hospital stay would find by number of neonatal death in each group divided by total number of neonates in same group.

Eligibility
Key inclusion criteria
Preterm neonates fulfill one of the following criteria’s will be enrolled in the study.
1- Gestational age of equal or less than 35weeks.
2- Weight less than 2000g.
Minimum age
4 Days
Maximum age
28 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neonates have visible or physically detected malformation, birth weight less than 1000gr, severe birth asphyxia, seriously ill baby and parent who declined consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Stata 14 used for sample size calculation. A hypothesized mean daily weight gain of 9.8±4.8gr for probiotic-fortified feed group take in consideration. In the preterm very low birth weight neonates, daily weight gain is 6.8±4.8 gr. With alpha error of 5% and power of 80%, for the two-sample means test a sample size of 84 neonates (42 baby for each group) estimated. To account for the loss of dropouts during the study period we accept 45 neonates for each group, totally the study will include 90 premature infants. 45 premature neonates would be feed by dual strain probiotic-fortified milk (Probiotic group), and the other 45 premature neonate will be feed by non-fortified milk (Control group). Initially raw data will collect in assessment and data collection sheets and then entered in SPSS software for statistical analysis. The evaluation of efficacy will mean difference , OR, RR and p-value.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/05/2020
Actual
15/05/2020
Date of last participant enrolment
Anticipated
10/10/2020
Actual
5/02/2021
Date of last data collection
Anticipated
10/11/2020
Actual
26/02/2021
Sample size
Target
90
Accrual to date
Final
107
Recruitment outside Australia
Country [1] 22239 0
Afghanistan
State/province [1] 22239 0
Kabul

Funding & Sponsors
Funding source category [1] 304723 0
Government body
Name [1] 304723 0
Abdullah Farhad Qayumi. Senior Strategic Planning and Research Manager, Ministry of Higher Education
Country [1] 304723 0
Afghanistan
Primary sponsor type
Individual
Name
Professor Mansoor Aslamzai, MD
Address
Department of Neonatology, Maiwand Teaching Hospital,1st district,1001, Kabul
Country
Afghanistan
Secondary sponsor category [1] 305042 0
None
Name [1] 305042 0
Address [1] 305042 0
Country [1] 305042 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305149 0
Research committee of Higher Education Development Program, Ministry of Higher Education
Ethics committee address [1] 305149 0
Higher Education and Development Program, Ministry of Higher Education, 3rd district, 1003, Kabul city.
Ethics committee country [1] 305149 0
Afghanistan
Date submitted for ethics approval [1] 305149 0
06/08/2019
Approval date [1] 305149 0
03/11/2019
Ethics approval number [1] 305149 0
Protocol no 13 letter no 564

Summary
Brief summary

Introduction: One of the main cause of neonatal mortality in Afghanistan is preterm birth (35%). such baby faces a lot of problems included challenging weight gaining and feeding intolerance. The study hypothesis is dual strain probiotic will increase weight gaining and decreased feeding intolerance in very low birth weight preterm neonates. Objective: To compare the effectiveness of dual strain probiotic fortified milk versus non-fortified breast milk on weight gaining and feeding intolerance of preterm and low birth weight neonates Kabul hospitals.
Method: Study Design is Randomized clinical Trail. The study population is comprised of preterm or low birth weight neonates at Malalai and Maiwand hospital in Kabul city during 2020. Sampling strategy:For this clinical trial, participants will select by block randomized sampling strategy. Totally the study will include 90 premature infants. 45 premature neonates would be feed by dual strain probiotic-fortified milk (Probiotic group), and the other 45 premature neonate will be feed by non-fortified milk (Control group).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99402 0
Prof Mansoor Aslamzai
Address 99402 0
Department of Neonatology, Maiwand Teaching Hospital, 1st district, 1001, Kabul city
Country 99402 0
Afghanistan
Phone 99402 0
+93700603998
Fax 99402 0
Email 99402 0
[email protected]
Contact person for public queries
Name 99403 0
Mansoor Aslamzai
Address 99403 0
Department of Neonatology, Maiwand Teaching Hospital, 1st district, 1001, Kabul city
Country 99403 0
Afghanistan
Phone 99403 0
+93700603998
Fax 99403 0
Email 99403 0
[email protected]
Contact person for scientific queries
Name 99404 0
Mansoor Aslamzai
Address 99404 0
Department of Neonatology, Maiwand Teaching Hospital, 1st district, 1001, Kabul city
Country 99404 0
Afghanistan
Phone 99404 0
+93700603998
Fax 99404 0
Email 99404 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
case-by-case basis at the discretion of Primary
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6467Study protocol    379086-(Uploaded-25-02-2020-14-25-29)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 379086-(Uploaded-02-04-2021-03-28-23)-Basic results summary.docx
Plain language summaryNo 1. Research question: Does dual strain probiotics ... [More Details]

Documents added automatically
No additional documents have been identified.