UCL Institute of Child Health A Longitudinal Preterm Growth Reference A study funded by the Co-ordinated by the Neonatal Data Analysis Unit NDAU MREC No: 07/ H0713/ 111 Neonatal Data Analysis Unit The Study Team Investigators Professor Neena Modi, Professor Tim Cole, Dr Huiqi Pan Research Fellow TBA NDAU Manager Mr Richard Colquhoun Objective • To construct a growth reference for weight, length and head circumference in preterm infants ≤ 34 weeks gestation from birth to term/near term • Using routinely collected clinical data entered into the Standardised Electronic Neonatal Database (SEND) and related neonatal.net systems A growth chart is series of smooth curves representing the distribution of measurements of interest within a population Content of growth charts a) Type of anthropometric indices eg weight, length, head circumference b) Summary data eg z-scores and percentiles c) Population eg boys, girls Centiles and standard deviation score; the bulleted points are two thirds of an SDS apart. Cole TJ BMJ 1994;308:641-642 Is a neonatal chart a reference or a standard? • A standard represents optimum growth (prescriptive) • A reference allows the comparison of any one individual against a population (descriptive) History of preterm growth charts In 1948 Dancis et al published the first Preterm Growth Reference Followed by: 1) Lubchenco et al (1963) 2) Battaglia et al (1966) 3) Usher and McLean (1969) 4) Babson et al (1970) 5) Brenner et al (1976) Other Preterm Growth References • Europe: Euro-Growth Reference; local (Brant 1976; Excler 1987; Lozano 1998; Bertino 2006) • Latin America: Gabriela (Chile 1989); Anchieta (Brazil 2004) • China: Fok 2003 Growth reference charts used in the United Kingdom • • • • • Tanner-Whitehouse Buckler-Tanner Cambridge Harvard Gairdner Pearson • UK 1990 Reference The UK 1990 Growth Reference Based on cross-sectional data, utilising birth weights, and therefore not suitable to follow longitudinal growth Study Methods POPULATION Infants born ≤ 34 weeks gestation admitted to neonatal units using a neonatal.net electronic newborn record Standard Clinical Practice • Maintain routine practice • No extra procedures • Measurements as clinical situation permits Variables Anonymised data comprising: a) b) c) d) e) f) g) Gestational age Sex Ethnicity Daily parenteral and enteral intake Maternal details Daily level of care Weight, length and head circumference measurements from birth to discharge Statistical Analysis The Cole LMS method will be used to construct smooth curves summarising the distribution of measurements by age and sex: L = Skewness of distribution M= Median of measurement S= Coefficient of variation Regulations and approvals • Research Ethics approval obtained • No patient consent required • Site specific approval (SSA) exempt • NHS Trust R&D approval necessary • National Information Governance Board (NIGB) approval not needed as data are anonymised What is required from participating units? • Nomination of 2 local co-ordinators • Liaison with the Neonatal Data Analysis Unit (NDAU) • Entry of high quality anthropometric measurements, at a frequency determined locally • We recommend no greater than weekly intervals The NDAU office will • approach your R&D Office on your behalf to obtain Trust approval • Local Principal Investigator not required Anthropometric measurements • Measurements taken by staff who have received training • Recommend 3 repeat measurements if clinical situation permits • Head circumference measurement between the forehead and the occiput with the hat removed • Weight measured net of attachments/devices • Length taken on a firm and flat surface by 2 people; 1 person holding the head whilst the other extends and hold the feet against the foot rest The neonatal.net record Weight , head circumference and length measurements can be entered on any given day 1) 2) 3) 4) 5) 6) 7) Select Patient Name Go to Patient Home Page Select Patient Data Select Daily Data (left hand column) Go to Input Forms box Click on Daily Details to load the Summary Data Enter the new data (weight, head circumference & length) at the top of the Summary 8) When complete, click Save and Close Where are we now with the study? To-date 77 UK neonatal units have agreed to participate Benefits of Participation • Contribution to a national study • The Child Growth Foundation will provide each unit with newly designed equipment • We will offer you on-site training in obtaining high quality anthropometric measurements References • Freeman JV, Cole TJ, Chinn S, Jones PRM, White EM. Preece MA. Cross sectional stature and weight reference curves for the UK, 1990. Arch Dis Child 1995;73:17-24 • Cole TJ, Green PJ. Smoothing reference centile curves: the LMS method and penalized liklihood. Stat Med 1992; 11:1305-19 • Growth reference charts for use in the United Kingdom. Wright CM, Booth IW, Buckler JM, Cameron N, Cole TJ, Healy MJ, Hulse JA, Preece MA, Reilly JJ, Williams AF. Arch Dis Child 2002;86:1114 Overview The new longitudinal reference will provide a unique tool for child health professionals to assess the growth of UK preterm infants The Research Office For further information or queries please contact: Mr Richard Colquhoun NDAU Manager Academic Neonatal Medicine Imperial College London Chelsea and Westminster Hospital 4th Floor, Lift Bank D 369 Fulham Road London, SW10 9NH T: 020 8746 5841 r.colquhoun@imperial.ac.uk