LOGIN TO YOUR ACCOUNT

Username
Password
Remember Me
Or use your Academic/Social account:

CREATE AN ACCOUNT

Or use your Academic/Social account:

Congratulations!

You have just completed your registration at OpenAire.

Before you can login to the site, you will need to activate your account. An e-mail will be sent to you with the proper instructions.

Important!

Please note that this site is currently undergoing Beta testing.
Any new content you create is not guaranteed to be present to the final version of the site upon release.

Thank you for your patience,
OpenAire Dev Team.

Close This Message

CREATE AN ACCOUNT

Name:
Username:
Password:
Verify Password:
E-mail:
Verify E-mail:
*All Fields Are Required.
Please Verify You Are Human:
fbtwitterlinkedinvimeoflicker grey 14rssslideshare1
Publisher: BioMed Central
Journal: BMC Pediatrics
Languages: English
Types: Article
Subjects: RCT, Prematurity, Preterm infants, Milk volume, Study Protocol, Neurodevelopment, Sepsis, Parenteral nutrition, Milk feeds, NEC
BACKGROUND\ud \ud In 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.\ud \ud METHODS/DESIGN\ud \ud Two 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.\ud \ud DISCUSSION\ud \ud Extensive 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.\ud \ud TRIAL REGISTRATION\ud \ud ISRCTN Registry; ISRCTN76463425 on 5 March, 2013.
  • The results below are discovered through our pilot algorithms. Let us know how we are doing!

    • 1. Centre for Maternal and Child Enquiries: United Kingdom. Perinatal Mortality 2009. London: CMACE; 2011.
    • 2. Field DJ, Dorling JS, Manktelow BN, Draper ES. Survival of extremely premature babies in a geographically defined population: prospective cohort study of 1994-9 compared with 2000-5. BMJ. 2008;336:1221-3.
    • 3. Hack M, Costello DW. Trends in the rates of cerebral palsy associated with neonatal intensive care of preterm children. Clin Obstet Gynecol. 2008;51:763-74.
    • 4. Berrington JE, Hearn RI, Bythell M, Wright C, Embleton ND. Deaths in preterm infants: changing pathology over 2 decades. J Pediatr. 2012;160:49-53.
    • 5. Rees CM, Pierro A, Eaton S. Neurodevelopmental outcomes of neonates with medically and surgically treated necrotizing enterocolitis. Arch Dis Child. 2007;92:F193-8.
    • 6. Morgan J, Young L, McGuire W. Slow advancement of enteral feed volumes to prevent necrotising enterocolitis in very low birth weight infants. Cochrane Database Syst Rev. 2013;3:CD001241.
    • 7. Hsu JF, Tsai MH, Huang HR, Lien R, Chu SM, Huang CB. Risk factors of catheter-related bloodstream infection with percutaneously inserted central venous catheters in very low birth weight infants: a center's experience in Taiwan. Pediatr Neonatol. 2010;51:336-42.
    • 8. Kelly DA. Preventing parenteral nutrition liver disease. Early Hum Dev. 2010;86(11):683-7.
    • 9. Nadroo AM, Lin J, Green RS, Magid MS, Holzman IR. Death as a complication of peripherally inserted central catheters in neonates. J Pediatr. 2001;138:599-601.
    • 10. Adams-Chapman I, Stoll BJ. Prevention of nosocomial infections in the neonatal intensive care unit. Curr Opin Pediatr. 2002;14:157-64.
    • 11. Makhoul IR, Sujov P, Smolkin T, Lusky A, Reichman B. Epidemiological, clinical, and microbiological characteristics of late-onset sepsis among very low birth weight infants in Israel: a national survey. Pediatrics. 2002;109:34-9.
    • 12. Nagata E, Brito AS, Matsuo T. Nosocomial infections in a neonatal intensive care unit: incidence and risk factors. Am J Infect Control. 2002;30:26-31.
    • 13. Chathas MK, Paton JB, Fisher DE. Percutaneous central venous catheterization. Three years' experience in a neonatal intensive care unit. Am J Dis Child. 1990;144:1246-50.
    • 14. Stoll BJ, Hansen N, Fanaroff AA, Wright LL, Carlo WA, Ehrenkranz RA, et al. Late-onset sepsis in very low birth weight neonates: the experience of the NICHD Neonatal Research Network. Pediatrics. 2002;110:285-91.
    • 15. Moore T, Hennessy E, Myles J, Johnson S, Draper E, Costeloe K, et al. Neurological and developmental outcome in extremely preterm children born in England in 1995 and 2006: the EPICure studies. BMJ. 2012;345:e7961.
    • 16. Johnson S, Wolke D, Marlow N. Developmental assessment of preterm infants at 2 years: validity of parent reports. Dev Med Child Neurol. 2008;50:58-62.
    • 17. Johnson S, Marlow N, Wolke D, Davidson L, Marston L, O'Hare A, et al. Validation of a parent report measure of cognitive development in very preterm infants. Dev Med Child Neurol. 2004;46:389-97.
    • 18. British Association of Perinatal Medicine. Report of a BAPM/RCPCH Working Group. Classification of health status at 2 years as a result of perinatal outcome. 2008. http://www.bapm.org/publications/documents/guidelines/ Outcome_BAPM_WG_report_v6_Jan08.pdf.. Accessed 24 Jan 2017.
    • 19. Mangham LJ, Petrou S, Doyle LW, Draper ES, Marlow N. The cost of preterm birth throughout childhood in England and Wales. Pediatrics. 2009;123:e312-27.
    • 20. Vermont Oxford Network: Vermont Oxford Network Database. Data for 31 neonatal units in the United Kingdom. 2011. https://public.vtoxford.org/ manuals-forms/members-area/. Accessed 29 Sep 2011.
    • 21. Kamoji VM, Dorling JS, Manktelow B, Draper ES, Field DJ. Antenatal umbilical Doppler abnormalities: an independent risk factor for early onset neonatal necrotizing enterocolitis in premature infants. Acta Paediatr. 2008;97:327-31.
    • 22. Neu J, Walker WA. Necrotizing enterocolitis. N Engl J Med. 2011;364:255-64.
    • 23. Holman RC, Stoll BJ, Curns AT, Yorita KL, Steiner CA, Schonberger LB. Necrotising enterocolitis hospitalisations among neonates in the United States. Paediatr Perinat Epidemiol. 2006;20:498-506.
    • 24. Johnson S, Evans TA, Draper ES, Field DJ, Manktelow BN, Marlow N, et al. Neurodevelopmental outcomes following late and moderate prematurity: population-based cohort study. Arch Dis Child Fetal Neonatal Ed. 2015;100(4):F301-8.
    • 25. Yelland LN, Salter AB, Ryan P. Relative risk estimation in Randomized Controlled Trials: a comparison of methods for independent observations. Int J Biostat. 2011;7. doi:10.2202/1557-4679.1278.
    • 26. Curtis L. Unit costs of health and social care 2012. Canterbury: Personal Social Services Research Unit, University of Kent; 2012.
    • 27. Briggs A, Gray A. The distribution of health care costs and their statistical analysis for economic evaluation. J Health Serv Res Policy. 1998;3:233-45.
    • 28. Thompson S, Barber J. How should cost data in pragmatic randomised trials be analysed? BMJ. 2000;320:1197-200.
    • 29. Shah DK, Doyle LW, Anderson PJ, Bear M, Daley AJ, Hunt RW, et al. Adverse neurodevelopment in preterm infants with postnatal sepsis or necrotizing enterocolitis is mediated by white matter abnormalities on magnetic resonance imaging at term. J Pediatr. 2008;153:170-5.
    • 30. Laptook AR, O'Shea TM, Shankaran S, Bhaskar B, NICHD Neonatal Network. Adverse neurodevelopmental outcomes among extremely low birth weight infants with a normal head ultrasound: prevalence and antecedents. Pediatrics. 2005;115:673-80.
    • 31. Murphy DJ, Hope PL, Johnson A. Neonatal risk factors for cerebral palsy in very preterm babies: case-control study. BMJ. 1997;314:404.
    • 32. Stoll BJ, Hansen NI, Adams-Chapman I, Fanaroff AA, Hintz SR, Vohr B, et al. Neurodevelopmental and growth impairment among extremely low-birthweight infants with neonatal infection. JAMA. 2004;292:2357-65.
    • 33. Dobson B. Paying to care: the cost of childhood disability. London: Joseph Rowntree Foundation; 1998. https://www.jrf.org.uk/report/paying-care-costchildhood-disability. Accessed 29 Sep 2011.
    • 34. Schlapbach LJ, Aebischer M, Adams M, Natalucci G, Bonhoeffer J, Latzin P, et al. Impact of sepsis on neurodevelopmental outcome in a Swiss National Cohort of extremely premature infants. Pediatrics. 2011;128:e348-57.
  • No related research data.
  • No similar publications.