Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202405729585049 Date of Approval: 22/05/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title SSOSS Trial (Sunflower Seed Oil in Small babies Study)
Official scientific title A phase II/III, randomized, open-label, clinical trial to evaluate the safety and efficacy of emollient therapy for very low birthweight infants (<1500g) in Uganda in promoting survival, health, growth and development compared to no emollient treatment.
Brief summary describing the background and objectives of the trial Background Globally, approximately 11% of all infants are born preterm. Complications of preterm birth cause nearly 1 million preventable deaths each year and are now the leading cause of the 5 million under-five child deaths that occur worldwide every year. Studies, primarily from South Asia, suggest that emollient therapy, ideally with sunflower seed oil (SSO), may reduce hospital-acquired infections, promote growth, and may have the potential to reduce neonatal mortality and enhance neurodevelopment. To date, data on the impact of SSO are limited. A sub-group analysis of a community based study comparing SSO to usual practice in India, demonstrated a significant reduction in neonatal mortality rate (NMR) for very low birth weight (VLBW, <1500g) infants, whilst an in-hospital study of infants born <33 weeks of gestation in Bangladesh found a reduction in NMR. No study has been reported from sub-Saharan Africa (SSA). The World Health Organization (WHO) has called for further studies, particularly from Africa. Objectives To evaluate the efficacy of emollient therapy with SSO – compared to standard care without use of emollients – among hospitalised very low birth weight (VLBW, <1500g) infants in Uganda on: the rate of in-hospital mortality, serious infections, hypothermia, growth, intraventricular haemorrhage, and skin condition; maternal depression and anxiety; maternal and neonatal interaction; infant growth and neurodevelopment at 12 month corrected age (chronological age reduced by the number of weeks born before 40 weeks of gestation); and infant mortality.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SSOSS
Disease(s) or condition(s) being studied Neonatal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2024
Actual trial start date
Anticipated date of last follow up 30/09/2028
Actual Last follow-up date
Anticipated target sample size (number of participants) 1242
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Emollient 3g of oil per kg body weight per application, three times a day For the duration of their stay in the hospital or until 28 completed days, whichever comes first Infants in the intervention arm will receive gentle, hygienic whole-body applications of emollient three times daily with 3 g of oil per kg body weight per application by research assistant for the duration of their stay in the hospital or until 28 completed days, whichever comes first. If discharged prior to completion of the 28th day, the intervention will be discontinued. 621
Control Group Standard care No application of emollient N/A N/A 621 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria: • 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 <Gestational Age); Severe respiratory distress (Downs Score ≥8); Respiratory Failure (Oxygen saturation <90% on oxygen therapy/bCPAP) • 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 New born: 0 Day-1 Month 0 Day(s) 1 Day(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 30/04/2024 Busitema University Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Pallisa Road Mbale 1460 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome · In-hospital mortality up to 28 days 28 days of age
Secondary Outcome · Mortality rates at day 7 and 28, and 12 months age day 7 and 28 and 12 months age
Secondary Outcome Incidence-density of neonatal sepsis defined as clinical features of infection with either a positive blood culture and/or elevated CRP > 10 at 0 and/or 36 hours from suspicion of infection Up to 28 days of age
Secondary Outcome Weight (WAZ) and head circumference (HCZ) using Intergrowth-21 at 28 days or discharge is earlier
Secondary Outcome · Growth velocity from birth to 28 days or discharge if earlier (g/kg/d and Delta z-score) birth to 28 days or discharge if earlier
Secondary Outcome · Anthropometric indices (WLZ, LAZ, WAZ, HCZ) using WHO child growth standards at term, 6, 12 months corrected age 2, 6, 12 months corrected age
Secondary Outcome · Skin condition scores and barrier function (transepidermal water loss) at day 1, 3, 7, 21, 28 (or discharge if earlier) [66] · day 1, 3, 7, 21, 28 or discharge if earlier
Secondary Outcome Development according to the GSED at 6, 12 months corrected age reported as a DAZ-score · 6 and 12 months corrected age
Secondary Outcome Neurological performance using Hammersmith Infant Neurological Examination score at 12 months corrected age, defined as <73 (suboptimal), and <65 (high probability of cerebral palsy) · 12 months corrected age
Secondary Outcome Hearing impairment at 6 months corrected age 6 months corrected age
Secondary Outcome Incidence-density and severity of hypothermia <35.5C until 72 hours of age – axillary temperature measures every 4 hours. Every 4 hours until 72 hours of age
Secondary Outcome Incidence and severity of retinopathy of prematurity using ophthalmic examinations starting at 28 days postnatal age and continuing every 1-2 weeks until term corrected age. 28 days and every 1-2 weeks until term corrected age
Secondary Outcome Incidence and severity of intraventricular haemorrhage on cranial ultrasound before 28 days of age (Papile grading) day 1, 3, 7 and 28
Secondary Outcome Maternal depression and anxiety at discharge of infant, and 6 weeks post partum (EPDS and GAD-7) [67, 68] discharge and 6 weeks post partum
Secondary Outcome · Maternal-Neonatal Interaction at discharge and 6 weeks post part (Perceived Maternal Parenting Self Efficacy, PMP-S-E) [69, 70] discharge and 6 weeks postpartum
Secondary Outcome Pre-intervention acceptability of the intervention and readiness by healthcare workers and caregivers (qualitative assessment) N/A
Secondary Outcome Post-intervention acceptability of the intervention by healthcare workers and caregivers (qualitative assessment) NA
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mbale Regional Referral Hospital Pallisa Road Mbale 921 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Research Council of Norway Drammensveien 288 Oslo 0283 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mbale Clinical Research Institute Pallisa Road Mbale 1966 Uganda Clinical Research Institute
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Thorkild Tylleskar Thorkild.Tylleskar@uib.no +4755588562 Arstadveien 21
City Postal code Country Position/Affiliation
Bergen 7804 Norway Professor
Role Name Email Phone Street address
Public Enquiries David Mukunya zebdaevid@gmail.com +256775152316 Pallisa Road
City Postal code Country Position/Affiliation
Mbale Uganda Associate Professor Busitema University
Role Name Email Phone Street address
Scientific Enquiries Kathy Burgoine kathy.burgoine@gmail.com +256778236572 Pallisa Road
City Postal code Country Position/Affiliation
Mbale Uganda Research Associate Mbale Clinical Research Institute
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes A link to summary results will be shared within the trial registration record within 12 months of study completion date. Individual participant data that underlie the results reported in each article/manuscript- after deidentification - will be made available. Study Protocol Summary results will be shared within the trial registration record within 12 months of study completion date. Following publication of an article, IPD will be available beginning 9 months and ending 36 months after publication. Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information