Effect of probiotic administration to mothers with very low birth weight neonates on some of the neonatal and maternal outcomes
Design
Randomized, superiority, placebo-controlled, double-blind trial with two parallel arms: 120 participants will be equally randomized into the groups using stratified block randomization referring to a computerized program
Settings and conduct
In Al-Zahra teaching hospitals in Tabriz, eligible infants and their mothers will be studied after receiving informed written consent from the mothers and if possible from fathers. The participants, those administering the interventions, care providers, and those collecting and analyzing data will be blinded.
Participants/Inclusion and exclusion criteria
Participants will be mothers with very low birth weight (1000-1500 g) infants. The mothers should have given birth in the past 48 h, have the desire and ability to breastfeed, and be able to attend the hospital at least once a week. The infants should be hospitalized for at least 7 days after starting the intervention. Exclusion criteria include triplets or more, infant's bad condition, contraindications to breastfeeding, the existence of obvious anomalies in the neonate, regular use of probiotics (in any form) by the mother, history of probiotic allergy or existence of immunity disorders in the mother, and unwillingness to participate in the study.
Intervention groups
Mothers will receive probiotic supplement in the intervention group and placebo in the control group, one capsule a day for 6 weeks.
Main outcome variables
Level of total serum bilirubin in the neonate at the fourth and seventh days of intervention, and postpartum depression (40-45 days of the intervention)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100414003706N42
Registration date:2022-11-22, 1401/09/01
Registration timing:prospective
Last update:2022-11-22, 1401/09/01
Update count:1
Registration date
2022-11-22, 1401/09/01
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotic administration to mothers with very low birth weight neonates on some of the neonatal and maternal outcomes
Public title
The effect of probiotic administration to mothers with very low birth weight neonates
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Neonatal birth weight of 1000-1500 g
Delivery in the past 48 h
Hospitalization of the infant for at least 7 days after the start of the intervention
Possibility of the mother to attend the hospital where the baby is admitted, at least once a week
Desire and ability to breastfeed her baby
Exclusion criteria:
Triplets or more
Bad condition of the infant diagnosed by a neonatologist
contraindications for feeding the infant with breast milk
Existence of obvious anomalies in the neonate
Regular use of probiotics (in any form) by the mother
History of sensitivity to probiotics in the mother
Immunodeficiency in the mother
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be individually randomized into intervention or control groups using stratified (single or twin pregnancy) block randomization with a block size of four and a ratio of 1:1. Allocation sequence will be generated using a computerized program. Identical sequentially numbered bottles containing probiotic or placebo capsules will be used to conceal the sequence and enable blinding.
Blinding (investigator's opinion)
Double blinded
Blinding description
Probiotic supplements and placebo will be prepared in identical shapes, colors, smells, and packages. The sequence generation and preparation of the packs will be done by a person not involved in participant recruitment or data collection. Identical sequentially numbered bottles containing probiotic or placebo capsules will be used to conceal the allocation sequence and enable blinding. The persons administering the interventions, health care providers, outcome assessors, and statistical analysts will be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Ave., Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2022-11-14, 1401/08/23
Ethics committee reference number
IR.TBZMED.REC.1401.735
Health conditions studied
1
Description of health condition studied
Hyperbilirubinemia (Jaundice)
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
2
Description of health condition studied
Postpartum depression
ICD-10 code
F32.8
ICD-10 code description
Other depressive episodes
3
Description of health condition studied
Mastitis
ICD-10 code
O91.22
ICD-10 code description
Nonpurulent mastitis associated with the puerperium
Primary outcomes
1
Description
Total serum bilirubin level in newborn
Timepoint
The fourth and seventh days of intervention
Method of measurement
laboratory assessment
2
Description
Postpartum depression
Timepoint
Baseline, 40-45 days after birth
Method of measurement
the Edinburgh Postpartum Depression Scale
Secondary outcomes
1
Description
Infant weight gain during 40-45 days
Timepoint
At baseline, 7th day of the intervention, discharge day, and 40 to 45 days after birth
Method of measurement
Using a digital scale
2
Description
Total duration of phototherapy (hours)
Timepoint
During neonatal period
Method of measurement
Daily assessment of infant medical record
3
Description
Duration of infant hospitalization
Timepoint
Until discharge from the hospital (if discharged earlier than 40 - 45 days, assessment after 40 -45 days for re-admission to hospital)
Method of measurement
Assessment of infant medical record and contact with the mother after 40 - 45 days in case of early discharge
4
Description
The composite variable of occurrence of serious neonatal problems (including bronchopulmonary dysplasia, sepsis, necrotizing enterocolitis, or retinopathy of prematurity)
Timepoint
40- 45 days of infancy
Method of measurement
Diagnosed by a neonatologist and an ophthalmologist based on clinical and para-clinical assessments (Retinopathy of prematurity will be assessed by an ophthalmologist after 28 days of infancy) which is recorded in the medical records.
5
Description
Occurrence of mastitis in the mother
Timepoint
During 40 -45 days of childbirth
Method of measurement
Using the Mastitis scale
6
Description
Postpartum anxiety
Timepoint
40-45 days after birth
Method of measurement
Specific Postpartum Anxiety Scale
Intervention groups
1
Description
Intervention group: capsules of the probiotic supplement containing CFU/g 3×109 Lacticaseibacillus paracasei subsp. Paracasei and Bifidobacterium lactis (animals) will be given once a day for 6 weeks to the mothers.
Category
Prevention
2
Description
Control group: placebo capsules containing starch powder will be given once a day for 6 weeks to the mothers.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
َAl-Zahra hospital
Full name of responsible person
Dr Maryam Vaezie
Street address
Bage-Shomal Intersection, South Artesh Ave., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Email
alzahra@tbzmed.ac.ir
Web page address
https://alzahrahosp.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
No. 2 Central building of the university, Golgasht street, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Alikamali
Position
PhD student in midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nursing & Midwifery Faculty, South Shariati Ave., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
59691-15868
Phone
+98 42 3342 3494
Email
m_kamali1984@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Ave., Tabriz
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The requested data will be provided to researchers for statistical analysis (meta-analysis) of the submitted proposal.
When the data will become available and for how long
starting immediately after the publication of the study results
To whom data/document is available
Data will be available to researchers working at academic organizations, as well as to the chief editor (and reviewers) of the journal of the submitted manuscript/s if requested.
Under which criteria data/document could be used
The data will be available to researchers upon request and submission of a proposal to perform a meta-analysis using IPD data after being unidentified. Also, in exceptional cases, data will be made available to the journal of submitted manuscript/s for checking the accuracy of the data
From where data/document is obtainable
Refer to the email address (alizades@tbzmed.ac.ir; mhammadalizadehs@gmail.com)
What processes are involved for a request to access data/document
The requests will be sent by email and data will be available within two weeks.