ADEPT - Abnormal Doppler Enteral Prescription Trial

<p>Abstract</p> <p>Background</p> <p>Pregnancies complicated by abnormal umbilical artery Doppler blood flow patterns often result in the baby being born both preterm and growth-restricted. These babies are at high risk of milk intolerance and necrotising enterocolitis, as well as post-natal growth failure, and there is no clinical consensus about how best to feed them. Policies of both early milk feeding and late milk feeding are widely used. This randomised controlled trial aims to determine whether a policy of early initiation of milk feeds is beneficial compared with late initiation. Optimising neonatal feeding for this group of babies may have long-term health implications and if either of these policies is shown to be beneficial it can be immediately adopted into clinical practice.</p> <p>Methods and Design</p> <p>Babies with gestational age below 35 weeks, and with birth weight below 10th centile for gestational age, will be randomly allocated to an "early" or "late" enteral feeding regimen, commencing milk feeds on day 2 and day 6 after birth, respectively. Feeds will be gradually increased over 9-13 days (depending on gestational age) using a schedule derived from those used in hospitals in the Eastern and South Western Regions of England, based on surveys of feeding practice. Primary outcome measures are time to establish full enteral feeding and necrotising enterocolitis; secondary outcomes include sepsis and growth. The target sample size is 400 babies. This sample size is large enough to detect a clinically meaningful difference of 3 days in time to establish full enteral feeds between the two feeding policies, with 90% power and a 5% 2-sided significance level. Initial recruitment period was 24 months, subsequently extended to 38 months.</p> <p>Discussion</p> <p>There is limited evidence from randomised controlled trials on which to base decisions regarding feeding policy in high risk preterm infants. This multicentre trial will help to guide clinical practice and may also provide pointers for future research.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN: 87351483</p

Reducing necrotizing enterocolitis in very low birth weight infants using quality-improvement methods

OBJECTIVE: Due to a rise in necrotizing enterocolitis (NEC, stage ≥2) among very low birth weight (VLBW, birth weight <1500g) infants from 4% in 2005-6 to 10% in 2007-8, we developed and implemented quality improvement (QI) initiatives. The objective was to evaluate the impact of QI initiatives on NEC incidence in VLBW infants. STUDY DESIGN: In September 2009 we developed a NEC QI multidisciplinary team that conducted literature reviews and reviewed practices from other institutions to develop a feeding protocol, which was implemented in December 2009. The team tracked intervention compliance and occurrence of NEC stage ≥2. In May 2010 we reviewed our nasogastric tube practice and relevant literature to develop a second intervention that reduced nasogastric tube indwelling time. The infants were divided into three groups: baseline (Jan 2008-Nov 2009, n219), QI phase 1 (Dec 2009-May 2010, n62), and QI phase 2 (June 2010-Nov 2011, n170). RESULT: The NEC incidence did not decrease after implementation of the feeding protocol in QI phase 1 (19.4%), but did decline significantly after changing nasogastric tube management in QI phase 2 (2.9%). Multivariable logistic regression analysis demonstrated a significant relationship between QI phase and the incidence of NEC. CONCLUSION: QI initiatives were effective in decreasing NEC incidence in our high human milk-feeding NICU. Nasogastric tube bacterial contamination may have contributed to our peak in NEC incidence