Request for Expression of Interest (EOI)
Background
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, Nigeria, Pakistan and Kenya).
The overall aim of the trial is to assess the effect of probiotic supplementation on mortality, morbidity, and growth in human milk fed 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) at 6 months in term SGA infants. The secondary objective is to assess the effect of probiotic supplementation on mortality at 6 months in infants of low birth weight (LBW). Other secondary outcomes are rates of hospitalization, 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).
WHO/MCA is seeking technical support for regulatory and clinical trial components for the first 12 months of the preparatory phase of the trial.
We invite academic and clinical trialists in institutions experienced in regulatory approvals and the processes and conduct of clinical trials in infants and children to submit an Expression of Interest (EOI). The EOI guidance below should be followed with submission no later than Monday 4th March 2024 5pm Geneva time. EOIs should be sent by email to Karen Edmond and Nigel Rollins (edmondk@who.int; rollinsn@who.int). EOIs received after this date will not be considered for selection.