SSOSS Trial (Sunflower Seed Oil in Small babies Study)
- Conditions
- Neonatal Diseases
- Registration Number
- PACTR202405729585049
- Lead Sponsor
- Mbale Clinical Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 1242
•Admission weight 800g to <1500g
•Admission age < 24 hours
•Mother +/- father who can understand English, Luganda, Lugwere, Ateso or Lumasaba
•Mother +/- father who are willing and able to give written informed consent for participation of their infant in the study.
•Mother aged 15 years or above
•Mother or father are not willing or are unable to give written, informed consent for participation of their infant in the study within 48 hours of admission to the NNU
•Second or later birth order or a multiple pregnancy, when the first or an earlier birth order infant is eligible for participation
•Infants with major congenital abnormality e.g. gastroschisis, cyanotic heart disease, upper airways abnormality
•Critically ill infants at time of enrollment: Babies with apnoeas requiring frequent stimulation or bag mask ventilation; shock (heart rate >200 beats per minute and/or Mean Arterial Pressure •Infants with generalized skin disease or a structural defect involving >5% body surface area likely to produce a defect in epidermal barrier function.
•Mother and father unwilling to come back to Mbale RRH for follow-up
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method