Expression of interest
Closing date for submissions Monday 3 March 2025 5pm Geneva time
The World Health Organization (WHO) Department of Maternal, Newborn, Child, Adolescent Health and Aging (MCA) is coordinating a trial to assess the effect of probiotic supplementation in 14,000 preterm and small for gestational age (SGA) infants in five low- and middle-income countries (LMICs) (Bangladesh, Ethiopia, Kenya, Nigeria, Pakistan).
The overall aim of the trial is to assess the effect of probiotic supplementation on mortality, morbidity, and growth in preterm and term SGA infants in the first six months of life in South Asia and Sub-Saharan Africa. The primary objective is to assess the effect of probiotic supplementation on (i) mortality at six months in preterm infants and (ii) underweight (low weight-for-age) free survival at 6 months in term SGA infants. Other secondary outcomes are suspected and confirmed sepsis, and necrotizing enterocolitis.
The trial will be implemented in urban and rural settings in the five sites over four years. It will involve recruitment in hospital in the first two days of life and follow up in the community through home visits. The probiotic supplement will be specially prepared for the trial and given orally or by feeding tube. It will be given to infants by their mothers in hospital or at home from day 2-30 of life. The mothers will be directly observed and supported by specially trained field workers (directly observed therapy, DOT). The trial will be implemented under strict International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Harmonised Guideline for Good clinical practice (ICH GCP) compliant protocols.
Infants will be enrolled over 18 months and followed up to 6 months of age. We anticipate the first infants will be enrolled in the trial in July 2025. We anticipate trial data management activities will start in April 2025.
Further information about the trial can be found at the following website.
The WHO PROPS Trial (PRObiotics in Preterm and Small for gestational age infants)
WHO/MCA is seeking technical support for ICHGCP compliant data management activities for the duration of the trial.
We invite expert clinical trial data management system developers to submit an Expression of Interest (EOI). The EOI guidance below should be followed with submission no later than Monday 3rd March 2025 5pm Geneva time.
EOIs should be sent by email to Karen Edmond (edmondk@who.int). EOIs received after this date will not be considered for selection.