]>
IRCT20100414003706N38 IRCT 2021-01-24 Tabriz University of Medical Sciences Probiotic supplementation for mother and for very low birth weight infants Effect of probiotic supplementation for mother and for infant on bilirubin level and weight gain in very low birth weight infants: a three parallel arm randomized controlled trial 2021-02-19 anticipated 75 Complete https://irct.ir/trial/52774 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participants will be individually randomized into interventions or control groups using stratified (single or twin pregnancy and the two recruitment center) block randomization with block size of three. Allocation sequence will be determined using a computerized program. Probiotic supplements or placebos will be prepared in sequentially numbered packages based on the allocation sequence, Blinding description: Probiotic supplements and placebo will be prepared in identical shape, color, smell and packages. The sequence generation and preparation of the packs will be done by a person not involved in participant recruitment or data collection. In the group with probiotic administration to the infant, probiotic placebo will be prescribed to the mother; in the group with probiotic administration to the mother, probiotic placebo will be prescribed to the infant; and in the control group, both mother and infant will be given probiotic placebo. The investigators, health care providers, outcome assessors, and statistical analyst will be blinded. 3 Condition 1: Hyperbilirubinemia (Jaundice). Condition 2: Mastitis. Condition 3: Very low birth weight. Intervention 1: Intervention group 1: One capsule of probiotic supplement containing 1.5 * 10 ^ 9 CFU of Lactobacillus Paracasei (subspecies Paracasei) will be given daily to the mother and one placebo capsule (similar to the probiotic capsule containing starch powder, dissolved in her mother's breast-milk) daily to her infant for 28 days . Intervention 2: Intervention group 2: One placebo capsule similar to a probiotic capsule containing starch powder will be given daily to the mother and one caosule of probiotic containing 1.5 * 10 ^ 9 CFU of Lactobacillus Paracasei (subspecies Paracasei, dissolved in her mother's breast-milk) daily to her infant for 28 days . Intervention 3: Control group: Both mothers and their infants will receive placebo capsules once a day for 28 days. Yes - There is a plan to make this available What will be shared: Requested data will be provided to researchers for statistical analysis (meta- analysis) of the submitted proposal. When: starting immediately after publication of the study results To whom: Data will be available to researchers working at academic organizations, as well as to 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 meta-analysis using IPD data after being unidentified. Also, in exceptional cases, data will be made available to journal of submitted manuscript/s for checking 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 a week. Comments:
public Mahtab Matin
Nursing & Midwifery Faculty, South Shariati Ave., Tabriz
Tabriz Iran (Islamic Republic of) 59691-15868 +98 44 4436 3557 mahtab.matin43@gmail.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) Iran (Islamic Republic of) Delivery in the past 48 h Desire and ability to breastfeed her baby Neonatal birth weight of 1000 to 1500 g Hospitalization of the infant for at least 7 days after the start of the intervention Possibility of the mother to attend hospital where the baby is admitted, at least once a week 18 years 45 years Female Triplets or more Infant bad condition diagnosed by a neonatologist. Contraindications to breastfeed Existence of obvious anomalies in the neonate Regular use of probiotics (in any form) by the mother History of probiotic allergy in the mother Immunodeficiency in the mother Unwillingness to participate in the study P59.9 O91.22 P07.10 Neonatal jaundice, unspecified Nonpurulent mastitis associated with the puerperium Other low birth weight newborn, unspecified weight Prevention Prevention Prevention Intervention group 1: One capsule of probiotic supplement containing 1.5 * 10 ^ 9 CFU of Lactobacillus Paracasei (subspecies Paracasei) will be given daily to the mother and one placebo capsule (similar to the probiotic capsule containing starch powder, dissolved in her mother's breast-milk) daily to her infant for 28 days . Intervention group 2: One placebo capsule similar to a probiotic capsule containing starch powder will be given daily to the mother and one caosule of probiotic containing 1.5 * 10 ^ 9 CFU of Lactobacillus Paracasei (subspecies Paracasei, dissolved in her mother's breast-milk) daily to her infant for 28 days . Control group: Both mothers and their infants will receive placebo capsules once a day for 28 days. Total serum bilirubin level. Timepoint: The third and seventh days of intervention. Method of measurement: laboratory assessment. Weight gain during neonatal period. Timepoint: At baseline, 7th day of intervention and 28th 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. Length of total parenteral nutrition. Timepoint: Daily assessment during hospital stay of the infant. Method of measurement: Daily assessment of infant medical record. Infant age at full enteral feeding (day). Timepoint: Daily assessment during hospital stay of the infant. Method of measurement: Daily assessment of infant medical record. Composite variable of occurrence of serious neonatal problems (including Bronchopulmonary dysplasia, sepsis, Necrotizing enterocolitis, or Retinopathy of prematurity). Timepoint: Until about 40 days of infancy. Method of measurement: Diagnosed by neonatologist and ophthalmologist based on clinical and para-clinical assessments (Retinopathy of prematurity will be assessed by an ophthalmologist after 28 days of infancy). Duration of infant hospitalization. Timepoint: Until discharge from hospital (if discharged earlier than 28 days, assessment after 28 days for re-admission to hospital). Method of measurement: Assessment of infant medical record and contact with the mother after 28 days in case of early discharge. Occurrence of mastitis in the mother. Timepoint: During 28 days of childbirth. Method of measurement: At least weekly assessment using the Mastitis scale. Tabriz University of Medical Sciences Approved 2021-01-18 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)