Condition 1: Hyperbilirubinemia (Jaundice). Condition 2: Postpartum depression. Condition 3: Mastitis. Neonatal jaundice, unspecified Other depressive episodes Nonpurulent mastitis associated with the puerperium
Conditions
Interventions
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
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Alikamali
Tabriz University of Medical Sciences
Outcome results
None listed