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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100414003706N38
Enrollment
75
Registered
2021-01-24
Start date
2021-02-19
Completion date
Unknown
Last updated
2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Hyperbilirubinemia (Jaundice). Condition 2: Mastitis. Condition 3: Very low birth weight. Neonatal jaundice, unspecified Nonpurulent mastitis associated with the puerperium Other low birth weight newborn, unspecified weight

Interventions

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 placeb

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.;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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahtab Matin

Tabriz University of Medical Sciences

mahtab.matin43@gmail.com+98 44 4436 3557

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 18, 2026