sepsis, diarrhoea and pneumonia Neonatal Diseases Pregnancy and Childbirth Paediatrics
Conditions
Interventions
Standard Care
ABHR Product
Sponsors
University of Liverpool
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| The main secondary outcomes are infant diarrhoea and lower respiratory tract infections from maternal reports. Other secondary outcomes include - Rates of omphalitis (photographed and expert-defined), Infant sepsis, meningitis, skin infections, tetanus, clinical jaundice, oedema, dehydration and neglected diseases (echinococcosise, foodborne trematodiases, leprosy, trachoma, yaws; all clinician verified). Mean differences in –z-scores according to the WHO growth standards at 3 months will compare effect of ABHR on linear and ponderal growth of the infant during the first 3 months of life. Economic outcomes for each participating family will also compared.;Outcomes related to the mother include - Antibiotic use, hand gel use, frequency of other hand washing episodes, substance use on cord, feeding practices, satisfaction. Numbers of women with sepsis related to recent delivery of an infant (maternal report, up to 3 months postnatally);Exploratory outcomes include participants wealth quintile based on possessions to explore the relationship between health inequalities and rates of maternal and infant morbidity. Interviews with participants and surveys of study villages will explore current hand hygiene practices and options of improving practice in rural Ugandan villages. | — |
Countries
Uganda
Contacts
Public ContactDavid Mukunya
Trial Manager
Outcome results
None listed