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| [ Print-friendly version ] |
| Speed of Increasing milk Feeds Trial |
| ISRCTN | ISRCTN76463425 |
| DOI | 10.1186/ISRCTN76463425 |
| ClinicalTrials.gov identifier | NCT01727609 |
| EudraCT number | |
| Public title | Speed of Increasing milk Feeds Trial |
| Scientific title | A multi-centre randomised controlled trial of two rates of daily increment of enteral feeding to prevent late-onset invasive infection in very preterm or low birth weight infants |
| Acronym | SIFT |
| Serial number at source | HTA: 11/01/25 |
| Study hypothesis |
It is hypothesised that the proportion of very preterm (<32 weeks) or very low birth weight [VLBW] (<1,500 g) infants surviving without moderate or severe disability at 24 months post menstrual age will be greater in the fast (30 ml/kg/day) versus slow (18 ml/kg/day) increasing milk feed regimen.
More details can be found at: http://www.hta.ac.uk/2909 Study protocol can be found at: http://www.hta.ac.uk/protocols/201100010025.pdf |
| Lay summary |
Background and study aims
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. Who can participate? The study will recruit 2,500 very preterm (<32 weeks) or VLBW (<1,500 g) infants from approximately 30 neonatal units within the UK and Ireland over 3 years. What does the study involve? With informed consent from parents, infants will be randomly allocated to receive either fast (30 ml/kg/day) or slow (18 ml/kg/day) increases in milk feed volumes.As well as assessing the effect of a faster feeding increment on the risk of severe or moderate disability, the study will also compare the rate of serious infection and necrotising enterocolitis [portions of the bowel undergo necrosis (tissue death)], the time taken to reach full milk feeds, the duration of nutrition is provided by intravenous drip, growth, and the length of hospital stay between the two groups.Infants will be followed up at 2 years of age via a questionnaire which will be posted to the parents. Finally, an economic evaluation will be undertaken to determine whether fast feeding advancement is a cost-effective treatment. What are the possible benefits and risks of participating? There will be no immediate direct benefit to those taking part in the study; however there should be benefits to future very preterm or VLBW babies as the results of the study are likely to influence NHS neonatal feeding policy and practice. As both the study rates of increase of milk feeds (fast and slow) are within rates currently used in UK neonatal units, there is no difference in risk between feeding regimens administered as part of the study and those administered as part of standard clinical care. Where is the study run from? SIFT is run from the National Perinatal Epidemiology Unit Clinical Trials Unit at the University of Oxford. When is the study starting and how long is it expected to run for? Recruitment will start in spring/summer 2013 and finish in summer 2016. Follow-up will start 2 years after the first infants are recruited (spring 2015) and continue until 2 years after the last infants are recruited (summer 2016). Who is funding the study? The National Institute for Health Research’s Health Technology Assessment Programme has provided the funding for the study. Who is the main contact? Chief Investigator, Jon Dorling: jon.dorling@nottingham.ac.uk Trial Coordinator, Beth Bosiak: elizabeth.bosiak@npeu.ox.ac.uk |
| Ethics approval | NRES Committee East Midlands – Nottingham 2, 31 January 2013, ref: 13/EM/0030 |
| Study design | Phase III multi-centre open-label randomised controlled trial |
| Countries of recruitment | Ireland, United Kingdom |
| Disease/condition/study domain | Neonatal feeding, preterm infants, very low birth weight infants, necrotising enterocolitis, late-onset invasive infection |
| Participants - inclusion criteria |
1. Gestational age at birth <32 weeks, or birth weight <1,500 g
2. The infant is receiving ≤30 ml/kg/day of milk at randomisation 3. Written informed parental consent is obtained To ensure the widest applicability to preterm infants across the UK, those exclusively breast milk fed, formula milk fed, or receiving mixed feeds will be included. |
| Participants - exclusion criteria |
1. Infants with severe congenital anomalies
2. Infants who, in the opinion of the treating clinician, have no realistic chance of survival 3. Infants who are unlikely to be traceable for follow-up at 24 months of age (for example, infants of non-UK residents) |
| Anticipated start date | 01/02/2013 |
| Anticipated end date | 31/01/2019 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 2,500 |
| Interventions |
The study will recruit 2,500 very preterm or VLBW from approximately 30 neonatal units within the UK and Ireland over 3 years.
Infants will be randomly allocated to receive either fast (30 ml/kg/day) or slow (18 ml/kg/day) increases in milk feed volumes. Until discharge they will be monitored for late-onset invasive infection, necrotising enterocolitis, time taken to reach full milk feeds, growth, duration of parenteral feeding, length of hospital stay, and length of time in intensive care. They will be assessed for moderate or severe disability at 24 months post menstrual age. |
| Primary outcome measure(s) | Moderate or severe disability at 24 months post menstrual age |
| Secondary outcome measure(s) |
1. Incidence of microbiologically-confirmed or clinically suspected late-onset invasive infection from trial entry until hospital discharge
2. Incidence of necrotising enterocolitis (NEC) [Bell stage 2 or 3] 3. Time taken to reach full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days) 4. Growth (weight and head circumference) at discharge 5. Duration of parenteral feeding before discharge 6. Length of time in intensive care 7. Length of hospital stay |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | https://www.npeu.ox.ac.uk/sift |
| Publications | |
| Contact name | Dr Jon Dorling |
| Address |
Nottingham University Hospitals NHS Trust
Academic Division of Child Health Queens Medical Centre |
| City/town | Nottingham |
| Zip/Postcode | NG7 2UH |
| Country | United Kingdom |
| jon.dorling@nuh.nhs.uk | |
| Sponsor | University of Oxford (UK) |
| Address |
Clinical Trials and Research Governance
Joint Research Office Block 60 Churchill Hospital Old Road, Headington |
| City/town | Oxford |
| Zip/Postcode | OX3 7LE |
| Country | United Kingdom |
| Sponsor website: | http://www.ox.ac.uk/ |
| Date applied | 05/03/2013 |
| Last edited | 14/03/2013 |
| Date ISRCTN assigned | 14/03/2013 |
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| © 2013 ISRCTN unless otherwise stated. | |
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