Developing a gold standard to confirm self report of breastfeeding

• Research type

  Research Study

• Full title

  Developing a gold standard method to confirm self report of exclusive breastfeeding by examining biochemical constituents of urine collected from breastfed, formula fed and both breast and formula fed infants up to 6 months postnatal age. A pilot study followed by a definitive study.

• IRAS ID

  126630

• Contact name

  David M Tappin

• Contact email

  goda11@udcf.gla.ac.uk

• Sponsor organisation

  NHS Greater Glasgow and Clyde

• Research summary

  Background
  Not breastfeeding is associated with increased morbidity and mortality in infants and mothers. In Scotland breastfeeding rates are among the lowest worldwide.
  Intervention trials to promote breastfeeding are ongoing. The MRC and Sheffield University are currently undertaking a financial incentive trial to promote breast feeding in the UK. All intervention trials rely on parental report to confirm feeding history. This is a limitation and source of possible bias.
  Breast milk contains human milk proteins called oligosaccharides. These can be detected in the urine of breastfed but not formula fed infants.

  Aim
  We will undertake a pilot study to examine the feasibility of measuring oligosaccharides in infant urine as a gold standard indicator of feeding practice.

  Method
  Infants less than 6 months admitted to Yorkhill Hospital for inpatient care will be recruited. 30 infants will be assessed in the pilot study. 10 exclusively breast fed; 10 mixed formula and breastfed and 10 exclusively formula fed.
  All infants who are seriously ill (CEWS>4) will be excluded. All infants on intravenous fluid will be excluded.
  Parents and nursing staff will complete a feeding questionnaire which will collect feeding history.
  Nursing staff will be asked to corroborate parent reported feeding history by observation of feeding practice. Parents will be asked about their experience of taking part and opinion on the process for research purposes.
  Urine samples will be collected by placing cotton wool balls in the infants nappy during routine nappy change.
  Urine will be extracted, deep frozen and sent anonymised for laboratory analysis. Researchers will be blinded to feed type and asked to categorise infant urine as from formula or breastfed infant.
  Further analysis will be undertaken to establish if a level of oligosaccharide can be correlated to exclusive versus mixed feeding.
  If successful a substancial amendement will be submitted for a larger definitive study

• REC name

  West of Scotland REC 5

• REC reference

  14/WS/1020

• Date of REC Opinion

  4 Jul 2014

• REC opinion

  Further Information Favourable Opinion