Hot Milk – September 2011
In this edition;
Diarrhoea and vomiting in children page 1
Questioning the evidence page 1-2
Latest Evidence on Breastfeeding pages2- 4
Diarrhoea and vomiting in children
Many of you will have seen this guidance that came out from NICE in 2009. However occasionally a mum formula feeding her baby still gets told to water down the baby’s formula, this guidance does not recommend that
Questioning the evidence
IFIT are trying to look at the science behind information for those babies who are not breastfed. In July we were fortunate to be visited by Maureen Minchin, who has an international reputation for her knowledge around infant feeding, and has contributed to the FREE interactive
e-learningforhealth website units on Infant Feeding.* She shared some thoughts about what questions to ask when we look at evidence submitted by baby milk companies.
1. Was the paper funded by the manufacturer?If so, was this disclosed publicly; if not, why not?Did the manufacturer provide the formula for the study (a form of funding), or was it bought at retail as parents do, without the maker knowing that what cans would be used in this research? (Trials have been stopped because of adverse reactions, and then new batches of formula provided by manufacturers produced fewer symptoms. The initial results were not reported; later ones were.)
2. Were the authors in any beneficial relationship with any relevant company, and was this disclosed (e.g., on industry advisory boards, in receipt of other research funding, employed as consultants, getting royalties on patents…) This does not by itself invalidate their findings. However, it does mean that they have a real or potential interest in outcomes the company would prefer to publish.
3. Was the studied product identical to the product now on sale (allowing for the unavoidable variations between batches of formula) or have other "innovations" happened since the studies were published? (eg, studies on formula using deodorised fish oil for omega 3 should not be cited as proof of safety for synthetic GM algal and fungal oils extracted with hexane and micro-encapsulated with bovine and soy protein.)
4. What results were published? Is all the relevant data tabulated and available, or are results simply cited as “on file” at the company? (Read the asterisked fine print on advertising leaflets.) Was the research published in a peer-reviewed journal which insists on author disclosure of conflict of interest? Has it been validated by a Cochrane Review?
5. Numbers in some studies are tiny, yet the intervention may be aimed at all babies. Do the company have a statistically validated policy of how many babies, over what period, need to be exposed to a new innovation to assess safety and efficacy? What outcomes were chosen for study? Simple outcomes such as physical growth can conceal multiple long-term harms such as diabetes or cardiac problems. Do studies include follow-up for behavioural or cognitive problems or chromosomal effects or reproductive development? (The study which showed more ovarian cysts in 4 month old artificially-fed (AF)girls and less testicular growth in 4 month old AF boys would seem to demand follow-up research past puberty, and investigation of adult fertility, for example.)
6. Was there a control group of exclusively breastfed babies? How carefully was this documented? Were the breastfed babies given even one formula feed postnatally, altering gut function even if fully breastfed thereafter? Similarly, were the babies on the tested formula given colostrum or other human milk at any stage? (In some studies AF babies get breastmilk for some weeks before the formula is tried, yet the formula is later sold to parents as safe from birth. A few days or weeks of breastmilk does affect gut development, and the timing and dose of exposure to allergens may be critical.) Confusing the groups benefits formula companies.
7.What was the drop-out rate, and why did children drop out of the study? If those that survive to the end are the healthiest and best able to cope, are the results applicable to the general population? Were all small or sick children excluded as trial participants, yet the product will be said to be safe from birth for all babies?
8. Were parents aware that their child was an experimental subject, and did they give informed consent? Were they poor families persuaded not to breastfeed or to wean early by the availability of free formula in the study? Have parents been given information about the trial outcomes, and will they be able to access help if problems emerge in their children over time?
9. Is what the company is saying consistent across its own range of products? If a company, for example, claims that its lower (or adapted) protein levels are beneficial to brain and kidney health, and has been lowering these levels in formulas for healthy term infants, how does it justify exposing small sick or preterm babies to much higher levels of protein which they have less ability to metabolise than healthy term infants? How do companies justify keeping other products on sale if they claim or imply that their use results in poorer immune health compared with the so-called “gold” products? Can companies show better outcomes in one group? If not, how do they justify the large added cost? If so, how can they sell product hat harms babies?
10. If the company information and representatives do not have answers to any of these questions, why not?
*Maureen urges healthworkers to log on and test out Module 8 (Growth and Nutrition which has the breastfeeding and formula feeding units) and give feedback.
Latest Evidence from UNICEF UK Baby Friendly Initiative
Frenotomy for infants with tongue tie improves breastfeeding ability and maternal nipple pain The purpose of this 12-month study was to determine whether frenotomy for infants with ankyloglossia (tongue tie) improved maternal nipple pain and ability to breastfeed. A secondary objective was to determine whether frenotomy improved the length of breastfeeding.
Neonates who had difficulty breastfeeding and significant ankyloglossia were enrolled in this randomised, single-blinded, controlled trial and assigned to either a frenotomy (30 infants) or a sham procedure (28 infants). Breastfeeding was assessed by a pre-intervention and post-intervention nipple-pain scale and the Infant Breastfeeding Assessment Tool. The same tools were used at the 2-week follow-up and regularly scheduled follow-ups over a 1-year period. The infants in the sham group were given a frenotomy before or at the 2-week follow-up if it was desired.
Both groups demonstrated statistically significantly decreased pain scores after the intervention. The frenotomy group improved significantly more than the sham group (P < .001). Breastfeeding scores significantly improved in the frenotomy group (P = .029) without a significant change in the control group. All but 1 parent in the sham group elected to have the procedure performed when their infant reached 2 weeks of age, which prevented additional comparisons between the 2 groups.
The authors conclude that when frenotomy is performed for clinically significant ankyloglossia, there is a clear and immediate improvement in reported maternal nipple pain and infant breastfeeding scores. They recommend additional research should be done to determine the optimal timing of frenotomy and the ideal screening tool to detect significant ankyloglossia.
Efficacy of Neonatal Release of Ankyloglossia: A Randomized Trial. Melissa Buryk, David Bloom, and Timothy Shope. Pediatrics. published 18 July 2011, 10.1542/peds.2011-0077
More research on tongue tie; Hogan M, Westcott C and Griffiths M (2005). Randomized, controlled trial of division of tongue-tie in infants with feeding problems. Journal of Paediatrics and Child Health 41: 246. 1
Griffiths DM (2004). Do tongue ties affect breastfeeding? J Hum Lact 20: 409-14.
Randomised trial compares hand expression with breast pumping
An American study of 68 mothers of newborns 12-36 hours old who were latching or sucking poorly were randomly assigned to either 15 minutes of bilateral electric pumping or 15 minutes of hand expression. Milk transfer, maternal pain, breastfeeding confidence and breastmilk expression experience immediately after the intervention were measured, as well as breastfeeding rates at 2 months after birth.
The median volume of expressed milk was higher from the electric pumping, range 1ml (0-40) compared to range 0.5ml (0-5) for hand expression (p=0.07). Outcome measures for milk transfer, maternal pain and breastmilk expression experience did not differ between intervention groups. However, mothers assigned to hand expression were more likely to be breastfeeding at 2 months, 96.1% compared to 72.7% (p=0.02).The authors conclude that hand expression in the early postpartum period may improve breastfeeding outcomes and call for more research.
Valerie J Flaherman, Barbara Gay, Cheryl Scott, Andrew Avins, Kathryn A Lee, and Thomas B Newman. Randomised trial comparing hand expression with breast pumping for mothers of term newborns feeding poorly. Arch. Dis. Child. Fetal Neonatal Ed. published 11 July 2011, 10.1136/adc.2010.209213
Nwet N Win, Colin W Binns, Yun Zhao, Jane A Scott, Wendy H Oddy. Breastfeeding duration in mothers who express breastmilk: a cohort study. International Breastfeeding Journal 2006; 1(1): 28.
Breastfeeding reduces risk of developing asthma-related symptoms
This study, of a cohort of 5,358 children, examined the associations of breastfeeding duration and exclusiveness with the risks of asthma-related symptoms in preschool children, and to explore whether these associations are explained by atopic or infectious mechanisms.
Compared to children who were breastfed for 6 months, those who were never breastfed had overall increased risks of wheezing, shortness of breath, dry cough and persistent phlegm during the first four years (Odds ratios 1.44 (95% Confidence Interval: 1.24, 1.66), 1.26 (1.07, 1.48), 1.25 (1.08, 1.44) and 1.57 (1.29, 1.91), respectively). Similar associations were observed for exclusive breastfeeding.
Shorter duration and non-exclusivity of breastfeeding were associated with increased risks of asthma-related symptoms in preschool children.
Duration and exclusiveness of breastfeeding and childhood asthma-related symptoms. AMM Sonnenschein-van der Voort, V.V.W. Jaddoe, RJP van der Valk, SP Willemsen, A Hofman, HA Moll, JC de Jongste, and L Duijts. Eur. Respir. J. published 20 July 2011, 10.1183/09031936.00178110
Prospective national study of sudden and unexpected postnatal collapse
Sudden and unexpected postnatal collapse (SUPC) of a healthy newborn infant is a very rare event that happens in 1 in 20,000 live, term babies. However, when it does occur, it carries a high risk of mortality and neurodisability in survivors.
This study collected data from all cases of SUPC referred through the British Surveillance Unit reporting scheme over a 13-month period. 45 cases were reported and in 15 cases an underlying abnormality was determined. However, in 30 cases no underlying cause was found and in 24 cases the clinical diagnosis was airway obstruction while breastfeeding or in the prone position.
The authors conclude that: “For the significant majority of newborn infants, it is clear that breastfeeding and skin-to-skin practices are safe, beneficial and should be recommended. For such recommendations to be safe for all infants, guidelines should include appropriate vigilance of infants. Responsibility should be with clinical staff to ensure that during breastfeeding and skin-to-skin practices, parents are able to assess the airway, breathing and colour of their infant. Where parental observation of these parameters may be impaired by exhaustion or sedation, the responsibility for vigilance should reside with the clinical staff".
UNICEF UK comment: This study highlights again the need for vigilance by health professionals to ensure babies wellbeing in the first hours after birth. Please see the Baby Friendly Initiative implementation guidance on Step 4 for more details.
Becher, Julie-Clare, Shetty S Bhushan, and Andrew J Lyon (2011). Unexpected collapse in apparently healthy newborns - a prospective national study of a missing cohort of neonatal deaths and near-death events.Arch Dis Child Fetal Neonatal Ed doi:10.1136/adc.2010.2087
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Report from the Infant Feeding Information Team, Blackpool and North Lancashire: September 2011
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