The effect of probiotic administration to mothers with low birth weight neonates

Phase 3

• Conditions: Condition 1: Hyperbilirubinemia (Jaundice). Condition 2: Postpartum depression. Condition 3: Mastitis.; Neonatal jaundice, unspecified; Other depressive episodes; Nonpurulent mastitis associated with the puerperium; P59.9; F32.8; O91.22

• Registration Number: IRCT20100414003706N42
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 122

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.