Guidance on clinical research involving infants, children and young people

This is an excellent update of relevance to clinicians, researchers and research ethics committees.

There is no disagreement that research in children is important and should be supported and encouraged with the need to strengthen child health research in the UK. This is highlighted in a recent Royal College report1 and in the National Institute of Health Research (UK) call for research into the management of children with long term conditions. The research environment is complex and regulated with processes and procedures in place to support research participants, researchers and organisations. These ‘processes’ can be quite difficult to work through. There are specific issues relating to children and this paper provides practical guidance on the ethical issues in relation to research involving children. This includes discussion of children's rights, research risk, and the complex issues of consent, assent and dissent. There are sections on research involving pregnant women, emergency situations and vulnerable children. There are useful summary discussions on sedation for practical procedures, dealing with unexpected findings, commercial sponsorship and payment for participation in research. It is clear from the document that the ethical principles underpinning the participation of children in clinical research have evolved considerably over the past few decades. The importance of research competency is highlighted with the need for researchers to receive training in Good Clinical Practice. As part of such training this article should be essential reading for researchers who plan to be, or are, involved in research in children. See page 887.

Rice Protein Based Formula for Cow's Milk Allergy

Extensively hydrolysed cow's milk protein formula are recommended as first line for cow's milk protein allergy, with amino acid based formulae for infants who are allergic to the peptides present in the hydrolysate. Soya is a potential alternative, although 10–15% of infants allergic to cow's milk protein do not tolerate soya (not recommended in infants less than 6 months). In this issue, Vandenplas et al report their experience with extensively hydrolysed rice protein based formula in infants with cow's milk protein allergy. Thirty-nine infants (mean age 3.4 months, range 0.5–6 months) were recruited. All had cow's milk protein allergy (confirmed by challenge apart from two with a past history of anaphylaxis). Feed tolerance was good (37/39), with a significant improvement in symptom scores in all infants (p<0.0001) and normal growth. The formula was nutritionally complete and fulfilled internationally accepted criteria for a therapeutic hypoallergenic formula—tolerated in 90% of children with proven cow's milk protein allergy—and is a potential alternative to cow's milk based extensively hydrolysed feeds. See page 933.

Fever in the Returning Traveller

In an excellent review article Halbert and colleagues discuss the assessment and management of fever in the returning traveller. A detailed travel and medical history, clinical examination and appropriate first-line investigations are essential. The majority of children will have a common self-limiting or easily treatable infection although other causes, including imported infections, which may be life-threatening or highly contagious, need to be considered. The review provides guidance on the initial assessment and management of such children with a focus on some of the more important imported infections, including malaria, dengue, typhoid fever, travellers' diarrhoea, respiratory infections, tuberculosis, schistosomiasis and rickettsial diseases. See page 938.

Bariatric Surgery for Childhood Obesity

Most obese children will become obese adults. The most obese children (BMI >3.5 SDS above the mean) are at very significant risk of obesity-related health problems (including psychosocial) during childhood, adolescence and adult life. Bariatric (obesity) surgery is a potential treatment option. There are specific NICE guidance regarding eligibility, although availability is patchy. Sachdev and colleagues report their experience of 6 patients (4 male, ages 14–16 years) who underwent surgery. Preoperative BMI SDS ranged from +3.5 to +5.2. All had significant comorbidity and had failed lifestyle management and medical treatment. Four had gastric bypass procedures, one had laparoscopic gastric banding and one a laparoscopic sleeve gastrectomy. No major post-operative complications were seen. Mean percentage weight loss (as a percentage of total body weight) was 22% at 6 months and 27% at 12 months, with a fall in mean BMI from +4.4 to +3.8, and +3.1 at 24 months. There were significant sustained reductions in comorbidities. This is important data. Surgery shouldn't be undertaken lightly and without full child and family engagement and multidisciplinary support, but this is clearly an important potential option in selected cases.

Increasing numbers of severely obese young people have undergone obesity surgery in the USA and in an editorial Marc Michalsky puts this paper into an international context—Adolescent Bariatric surgery in the United Kingdom; a call for continued study and open dialogue. See pages 894 and 885.

Recent Advances in Paediatric Dermatology

This is an excellent review that provides up-to-date management guidance for common skin conditions (acne, atopic eczema, infantile haemangioma, psoriasis), supported by helpful commentaries and algorithms. Propranolol for the management of infantile haemangioma is discussed in detail. The authors also review important developments including recognition of Kaposiform Hemangioendothelioma as a differential of infantile haemangioma, rheumatology overlap disorders, psoriaisis comorbidities, assessment of pigmented lesions, management of onychomycosis, and recognition of Coxsackie A6 hand, foot and mouth disease. The article is focussed and informative. The authors call for continued research into the recognition and treatment of the many dermatology disorders in children and into the complexities of adapting management plans to the paediatric population. See page 944.

In Education & Practice this month

There are two best practice reviews/updates: structured approach to the child with a white reflex and assessment and management of the child with benign intracranial hypertension. There are guideline reviews on gastro-oesophageal reflux and ulcerative colitis; a ‘how to use’ bacterial cultures for lower respiratory tract infection in cystic fibrosis; and a couple of epilogue questions. All excellent CPD and well worth working through.