Does probiotic treatment to newborns born with a low birth weight decrease the risk of severe disease in the year of life?

Phase 3

• Conditions: sepsis; Neonatal Diseases; Nutritional, Metabolic, Endocrine

• Registration Number: PACTR202309763146420
• Lead Sponsor: niversity of Gothenburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-26
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Age 1-7 days old AND born at one of the study health facilities, AND a written informed consent by the mother, AND one or more of the following criteria (1, 2, or 3)
1.Low birth weight defined as birth weight 1000-2499 g as measured on the birth chart.
2.Preterm birth defined as gestational age at birth <37 weeks according to the birth chart.
3.Guardian agrees to complete the planned follow up visits
4.Permanent residents in the defined catchment area
5.Able to tolerate oral feeds

Exclusion Criteria

Exclusion criteria
1.Infants admitted with severe diseases and in need of urgent medical intervention or referral due to the latter severity.
2.Infants with obvious congenital malformations
3.No information on birth weight or estimated gestational age
4.Infants who weigh more than 2500g on inclusion day when weighed by the study nurse.

Participant discontinuation from interventional treatment criteria
1.Withdrawal of consent by the guardian during the entire continuation of the trial. Participants will be excluded from analysis, but will be followed up according to standard health management in addition to active and passive follow-up on side effects and adverse events also after withdrawal due to safety aspects of the individual.
2.Referral to another health facility beyond the reach of the study staff
3.Severe disease
4.At the discretion of the principal investigator
3.6.2.2 Participant discontinuation from further study follow-up in accordance to protocol
1.Withdrawal of consent by the mother or caregiver during the entire continuation of the trial. Study participants will be excluded from the analysis, but will be followed up according to standard health management in addition to active and passive follow-up on side effects and adverse effects
2.Loss to follow up
3.Participant will have moved out of the study catchment zone

Study & Design

• Study Type: Interventional
• Study Design: Not specified