Infant formula composition and educational performance: a protocol to extend follow-up for a set of randomised controlled trials using linked administrative education records
Introduction The effect of infant nutrition on long-term cognition is important for parents and policy makers. However, most clinical trials typically have short follow-up periods, when measures of cognition are poorly predictive of later function. The few trials with longer-term follow-up have high...
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BMJ Publishing Group
2020-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/7/e035968.full |
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| author | Ruth Gilbert Maximiliane Verfürden Katie Harron John Jerrim Mary Fewtrell |
| author_facet | Ruth Gilbert Maximiliane Verfürden Katie Harron John Jerrim Mary Fewtrell |
| author_sort | Ruth Gilbert |
| collection | DOAJ |
| description | Introduction The effect of infant nutrition on long-term cognition is important for parents and policy makers. However, most clinical trials typically have short follow-up periods, when measures of cognition are poorly predictive of later function. The few trials with longer-term follow-up have high levels of attrition, which can lead to selection bias, and in turn to erroneous interpretation of long-term harms and benefits of infant nutrition. We address the need for unbiased, long-term follow-up, by linking measures of educational performance from administrative education records. Educational performance is a meaningful marker of cognitive function in children and it is strongly correlated with IQ. We aim to evaluate educational performance for children who, as infants, were part of a series of trials that randomised participants to either nutritionally modified infant formula or standard formula. Most trialists anticipated positive effects of these interventions on later cognitive function.Methods and analysis Using data from 1923 participants of seven randomised infant formula trials linked to the English National Pupil Database (NPD), this study will provide new insights into the effect of nutrient intake in infancy on school achievement. Our primary outcome will be the mean differences in z-scores between intervention and control groups for a compulsory Mathematics exam sat at age 16. Secondary outcomes will be z-scores for a compulsory English exam at age 16 and z-scores for compulsory Mathematics and English exams at age 11. We will also evaluate intervention effects on the likelihood of receiving special educational needs (SEN) support. All analyses will be performed separately by trial.Ethics and dissemination Research ethics approval, and approval from the Health Research Authority Confidentiality Advisory Group, has been obtained for this study. The results of this study will be disseminated to scientific, practitioner, and lay audiences, submitted for publication in peer-reviewed journals, and will contribute towards a PhD dissertation. |
| format | Article |
| id | doaj-art-297230a3cd994722a8ab229f7f543d81 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-297230a3cd994722a8ab229f7f543d812024-12-04T18:25:09ZengBMJ Publishing GroupBMJ Open2044-60552020-07-0110710.1136/bmjopen-2019-035968Infant formula composition and educational performance: a protocol to extend follow-up for a set of randomised controlled trials using linked administrative education recordsRuth Gilbert0Maximiliane Verfürden1Katie Harron2John Jerrim3Mary Fewtrell4Population, Policy and Practice Research and Teaching Department, UCL Great Ormond Street Institute of Child Health, London, UK5 Population, Policy and Practice, University College London Great Ormond Street Institute of Child Health, London, United KingdomUCL Great Ormond Street Institute of Child Health, University College London, London, UK7 UCL Institute of Education, University College London Institute of Education, London, UK2 UCL Great Ormond Street Institute of Child Health, University College London, London, UKIntroduction The effect of infant nutrition on long-term cognition is important for parents and policy makers. However, most clinical trials typically have short follow-up periods, when measures of cognition are poorly predictive of later function. The few trials with longer-term follow-up have high levels of attrition, which can lead to selection bias, and in turn to erroneous interpretation of long-term harms and benefits of infant nutrition. We address the need for unbiased, long-term follow-up, by linking measures of educational performance from administrative education records. Educational performance is a meaningful marker of cognitive function in children and it is strongly correlated with IQ. We aim to evaluate educational performance for children who, as infants, were part of a series of trials that randomised participants to either nutritionally modified infant formula or standard formula. Most trialists anticipated positive effects of these interventions on later cognitive function.Methods and analysis Using data from 1923 participants of seven randomised infant formula trials linked to the English National Pupil Database (NPD), this study will provide new insights into the effect of nutrient intake in infancy on school achievement. Our primary outcome will be the mean differences in z-scores between intervention and control groups for a compulsory Mathematics exam sat at age 16. Secondary outcomes will be z-scores for a compulsory English exam at age 16 and z-scores for compulsory Mathematics and English exams at age 11. We will also evaluate intervention effects on the likelihood of receiving special educational needs (SEN) support. All analyses will be performed separately by trial.Ethics and dissemination Research ethics approval, and approval from the Health Research Authority Confidentiality Advisory Group, has been obtained for this study. The results of this study will be disseminated to scientific, practitioner, and lay audiences, submitted for publication in peer-reviewed journals, and will contribute towards a PhD dissertation.https://bmjopen.bmj.com/content/10/7/e035968.full |
| spellingShingle | Ruth Gilbert Maximiliane Verfürden Katie Harron John Jerrim Mary Fewtrell Infant formula composition and educational performance: a protocol to extend follow-up for a set of randomised controlled trials using linked administrative education records BMJ Open |
| title | Infant formula composition and educational performance: a protocol to extend follow-up for a set of randomised controlled trials using linked administrative education records |
| title_full | Infant formula composition and educational performance: a protocol to extend follow-up for a set of randomised controlled trials using linked administrative education records |
| title_fullStr | Infant formula composition and educational performance: a protocol to extend follow-up for a set of randomised controlled trials using linked administrative education records |
| title_full_unstemmed | Infant formula composition and educational performance: a protocol to extend follow-up for a set of randomised controlled trials using linked administrative education records |
| title_short | Infant formula composition and educational performance: a protocol to extend follow-up for a set of randomised controlled trials using linked administrative education records |
| title_sort | infant formula composition and educational performance a protocol to extend follow up for a set of randomised controlled trials using linked administrative education records |
| url | https://bmjopen.bmj.com/content/10/7/e035968.full |
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