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IRCT20100414003706N42 IRCT 2022-11-22 Tabriz University of Medical Sciences The effect of probiotic administration to mothers with low birth weight neonates The effect of probiotic administration to mothers with low birth weight neonates on some of the neonatal and maternal outcomes 2022-12-22 anticipated 122 Complete https://irct.ir/trial/65451 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participants will be individually randomized into intervention or control groups using stratified (single/twin pregnancy and infant birth weight (1000-15000/1501-2000)) 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 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. 3 Condition 1: Hyperbilirubinemia (Jaundice). Condition 2: Postpartum depression. Condition 3: Mastitis. Intervention 1: 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. Intervention 2: Control group: placebo capsules containing starch powder will be given once a day for 6 weeks to the mothers. Yes - There is a plan to make this available What will be shared: The requested data will be provided to researchers for statistical analysis (meta-analysis) of the submitted proposal. When: starting immediately after the publication of the study results To whom: 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. Conditions: 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 Where to obtain: Refer to the email address (alizades@tbzmed.ac.ir; mhammadalizadehs@gmail.com) How to obtain: The requests will be sent by email and data will be available within two weeks. Comments:
public Maryam Alikamali
Nursing & Midwifery Faculty, South Shariati Ave., Tabriz
Tabriz Iran (Islamic Republic of) 59691-15868 +98 42 3342 3494 m_kamali1984@yahoo.com Tabriz University of Medical Sciences scientific Sakineh Mohammad-Alizadeh-Charandabi
Faculty of Nursing & Midwifery, South Shariati Ave., Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6969 alizades@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Neonatal birth weight of 1000 to 2000 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 18 years 45 years Female 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 P59.9 F32.8 O91.22 Neonatal jaundice, unspecified Other depressive episodes Nonpurulent mastitis associated with the puerperium Prevention Placebo 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. Control group: placebo capsules containing starch powder will be given once a day for 6 weeks to the mothers. Total serum bilirubin level in newborn. Timepoint: The fourth and seventh days of intervention. Method of measurement: laboratory assessment. Postpartum depression. Timepoint: Baseline, 40-45 days after birth. Method of measurement: The Edinburgh Postpartum Depression Scale. 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. Total duration of phototherapy (hours). Timepoint: During neonatal period. Method of measurement: Daily assessment of infant medical record. 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. 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. Occurrence of mastitis in the mother. Timepoint: During 40 -45 days of childbirth. Method of measurement: Using the Mastitis scale. Postpartum anxiety. Timepoint: 40-45 days after birth. Method of measurement: Specific Postpartum Anxiety Scale. Tabriz University of Medical Sciences Approved 2022-11-14 Ethics committee of Tabriz University of Medical Sciences No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Ave., Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)