Probiotic supplementation for mother and for very low birth weight infants

Phase 3

Recruiting

• 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; O91.22; P07.10; P59.9

• Registration Number: IRCT20100414003706N38
• 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: 22 February 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 75

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.