A multi-centre randomised controlled trial of two speeds of daily increment of milk feeding in very preterm or very low weight infants.
Very preterm babies are unable to tolerate nutritional volumes of milk without complications so require parenteral nutrition whilst milk feeds are built up. The best rate of increasing these feeds to achieve full milk feeds without causing complications is not yet known and a trial is needed to determine this balance. Short and long-term outcomes for preterm babies are affected by strategies that reduce infection rates, reduce necrotising enterocolitis (NEC) rates, promote adequate growth, and encourage earlier discharge. Feeding strategies impact on all of these and this study will examine two rates of increasing milk feeds with a primary focus of determining the effect on rate of survival without moderate or severe disability.
This diagram indicates that the SIFT trial is split into 3 stages: pre-intervention, intervention, and post-intervention.
The pre-intervention stage is further divided into the following 4 steps: preterm or VLBW baby, assess for eligibility, obtain parental consent, and then randomisation.
The intervention stage is divided into the two treatments: fast (30 ml/kg/day) and slow (18 ml/kg/day) increases in milk feed volumes.
The post-intervention stage is divided into the following 2 steps: discharge and then 2 year follow-up.
Survival of preterm infants has increased greatly over the years, so a major aim now is to improve the long term outlook for these infants and to avoid serious complications. The way infants are fed in early life affects short and long-term health and survival.
Because the bowels of preterm infants have not matured, they cannot digest large volumes of milk feeds straight away. Until the gut matures, nutrition is provided by intravenous drip while the amount of milk given is gradually increased over time. Increasing the amount of milk rapidly may increase the risk of gut complications. Increasing the amount of milk given more slowly means that intravenous nutrition is needed for longer? there is an associated risk of infection proportional to the time the intravenous line is present in the bloodstream of these infants. Despite the importance of milk feeding preterm infants, there have been few studies to inform how best to balance these risks, and what the best way to increase feeds in these infants is – this study sets out to address this missing information.
The study will compare two different rates of increase of milk feeds, one 'fast' and one 'slow', both within rates currently used in UK neonatal units. The study aims to find out if either rate gives better outcomes for the infants. Investigators will measure a variety of outcomes, such as survival without disability, infection, bowel problems, growth and long-term physical and mental development, as well as the impact on families and the NHS, including costs.
The study will be led by an established team of researchers who have run similar studies before, and will use an established network of neonatal units that have taken part in previous studies.
Infants will be randomly allocated to receive either a fast (30 ml/kg/day) or slow (18 ml/kg/day) increase in milk feed volumes.
- Gestational age at birth <32 weeks, or birth weight <1,500 g
- The infant is receiving ?30 ml/kg/day of milk at randomisation
- Written informed parental consent is obtained
- Infants with a severe congenital anomaly
- Infants who, in the opinion of the treating clinician, have no realistic chance of survival
- Infants who are unlikely to be traceable for follow-up at 24 months of age (for example, infants of non-UK residents)
The target sample size is 2,800 infants from approximately 60 neonatal units within the UK and Ireland over 3 years commencing in spring/summer 2013.
Coordination, Sponsorship and Funding
This multi-centre trial is coordinated from the National Perinatal Epidemiology Unit Clinical Trials Unit (NPEU CTU) at the University of Oxford and is sponsored by the University of Oxford. Funding is provided by the National Institute of Health Research (NIHR) Health Technology Assessment (HTA) programme.
- REC Reference:
- Clinical Trials Unit:
- National Perinatal Epidemiology Unit CTU
- University of Oxford
- NIHR Health Technology Assessment (HTA) Programme
- Recruitment Target:
- 2,800 (recruitment total 2,804)
- Duration of Study:
- September 2013 - January 2019