The Speed of Increasing milk Feeds: a randomised controlled trial

Abstract

BackgroundIn the UK, 1–2% of infants are born very preterm (<32 weeks of gestation) or have very low birth weight (<1500 g). Very preterm infants are initially unable to be fed nutritional volumes of milk and therefore require intravenous nutrition. Milk feeding strategies influence several long and short term health outcomes including growth, survival, infection (associated with intravenous nutrition) and necrotising enterocolitis (NEC); with both infection and NEC being key predictive factors of long term disability. Currently there is no consistent strategy for feeding preterm infants across the UK. The SIFT trial will test two speeds of increasing milk feeds with the primary aim of determining effects on survival without moderate or severe neurodevelopmental disability at 24 months of age, corrected for prematurity. The trial will also examine many secondary outcomes including infection, NEC, time taken to reach full feeds and growth.Methods/designTwo thousand eight hundred very preterm or very low birth weight infants will be recruited from approximately 30 hospitals across the UK to a randomised controlled trial. Infants with severe congenital anomaly or no realistic chance of survival will be excluded. Infants will be randomly allocated to either a faster (30 ml/kg/day) or slower (18 ml/kg/day) rate of increase in milk feeds. Data will be collected during the neonatal hospital stay on weight, infection rates, episodes of NEC, length of stay and time to reach full milk feeds. Long term health outcomes comprising vision, hearing, motor and cognitive impairment will be assessed at 24 months of age (corrected for prematurity) using a parent report questionnaire.DiscussionExtensive searches have found no active or proposed studies investigating the rate of increasing milk feeds. The results of this trial will have importance for optimising incremental milk feeding for very preterm and/or very low birth weight infants. No additional resources will be required to implement an optimal feeding strategy, and therefore if successful, the trial results could rapidly be adopted across the NHS at low cost.Trial registrationISRCTN Registry; ISRCTN76463425 on 5 March, 2013.

Controlled Trial of Two Incremental Milk-Feeding Rates in Preterm Infants

“…The trial was a multicenter, parallel-group, randomized, controlled trial that followed a published protocol, 17 also available with the full text of this article at NEJM.org. The trial was approved by the East Midlands National Research Ethics Committee and the National Maternity Hospital Ethics Committee in Dublin and overseen by independent steering and data and safety monitoring committees.…”

Measurement of gut oxygenation in the neonatal population using near-infrared spectroscopy: a clinical tool?

“…NIRS measurement of abdominal rSO 2 corresponded with Doppler ultrasounds of the SMA blood flow in preterm neonates (p=0.02) in whom enteral feeds had commenced but were not yet fully established. Whether splanchnic oxygenation measurements in the first days of life in those high-risk groups can predict severe complications such as NEC and whether early or late feeding regimen can be used to prevent such complications remains to be explored 26 27. DeWitt et al 28 studied gut NIRS in infants with congenital heart disease.…”

Enteral lactoferrin to prevent infection for very preterm infants: the ELFIN RCT

“…The Speed of Increasing Milk Feeds Trial (SIFT) was designed to allow infants to be enrolled in both trials. 48 The ELFIN trial and SIFT shared procedures and, in some cases, joint data collection forms and other documentation. Other trials being run simultaneously in any units were discussed by the chief investigators or their delegated representative to agree whether or not joint recruitment was appropriate and likely to be acceptable.…”

“…A qualitative analysis and exploration of participants' parents views and expectations has been undertaken in collaboration with the SIFT investigators. 48 Given that this study included SIFT participants predominantly (with few ELFIN trial participants), the findings will be reported within the SIFT report.…”