Efficacy of probiotic supplementation in preterm and small for gestational age infants: a multi-centre, placebo-controlled, individually-randomised trial
Improvement in health outcomes (survival, necrotising enterocolitis, infections and growth)
1. Screening, assessment of eligibility, enrolment: 1.1. Screening: Hospital staff (i.e. the doctors and nurses in the hospital who are routinely caring for mothers during labour and babies after birth) are part of the study team and have approval from the hospital administration units to notify live births to the site research team. Notification will occur as soon as possible after birth and within 48 hours. The hospital staff will ask all mothers of all live-born babies for authorisation to be approached by the research team as soon as feasible after birth and within 48 hours. The mothers will be given a copy of the screening information sheet by the hospital staff or the hospital staff will read the information sheet to the mother. If the mother gives authorisation, the research team will then visit the family while the baby is still in hospital, inform the family about the study and ask the mother of the infant for their informed written consent to conduct the screening procedures (as listed in the table below). Mothers will be given as much time as possible to reflect on participation. The research team will explain that consent is needed before the baby is 48 hours old because probiotics may have maximum benefit in very young babies under 2 days of age. The research team will explain that if the mother is unable to decide it will not influence any care she receives from the study hospital. 1.3. Consent for the main trial: The mothers of eligible infants will be asked for informed written consent for the infant to be randomised and included in the trial. This consent will be done by senior experienced research staff who are not hospital staff. At the time of screening the mother will be asked if she would like to hear about the main trial as well or if she would like the team to return at a more convenient time. A standardised informed consent form will be used and the procedures below will be followed. The mother of the infant is required to give consent i
1. <48 hours of age at the time of enrolment 2. Preterm (appropriate for gestational age [AGA] or small for gestational age [SGA]) or term SGA infants 3. Likely to be in the study area for the next 6 months
1. <28 weeks gestation 2. Not taking enteral feeds (e.g. due to a major congenital abnormality, mechanically ventilated, post-surgery or too unwell to be fed) 3. Confirmed sepsis at the time of enrolment 4. Indwelling central lines (including umbilical catheter/central venous line) (infants with peripheral intravenous lines will not be excluded) 5. Multiple births (e.g. twins, triplets)