BabyGel Trial

Phase 3

Recruiting

• Conditions: sepsis, diarrhoea and pneumonia; Neonatal Diseases; Pregnancy and Childbirth; Paediatrics

• Registration Number: PACTR202004705649428
• Lead Sponsor: niversity of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-17
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 5932

Inclusion Criteria

• Participant is willing and able to give informed consent for participation in the study.
• Female, aged 18 years or above, or those under 18 so long as emancipated.
• At least 34 weeks pregnant
• Living in one of the villages in the Mbale or Budaka Districts defined within this study protocol, and planning to be living in that same village for the first 3 months after birth

Exclusion Criteria

• Women who are pregnant and not living in one of the villages specified in this protocol.
• Women who have previously participated in the BabyGel study and present with a further pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be death or severe infant illness in the first 90 days of life. Severe illness = an illness that is associated with any of the following danger signs observed or verified by a study clinician: inability to feed or vomiting of all intake, lethargy or unconsciousness, severe lower chest in-drawing, axillary temperature of =37.5 °C or <35.5 °C, grunting, cyanosis, convulsions or a history of convulsions, and/or results in hospitalization and/or results in death).