Paediatrics (RCH) - Research Publications
Permanent URI for this collection
Search Results
1 - 2 of 2
-
ItemProbiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial(BMC, 2012-08-29)BACKGROUND: Infant colic, characterised by excessive crying/fussing for no apparent cause, affects up to 20% of infants under three months of age and is a great burden to families, health professionals and the health system. One promising approach to improving its management is the use of oral probiotics. The Baby Biotics trial aims to determine whether the probiotic Lactobacillus reuteri DSM 17938 is effective in reducing crying in infants less than three months old (<13.0 weeks) with infant colic when compared to placebo. DESIGN: Double-blind, placebo-controlled randomised trial in Melbourne, Australia. PARTICIPANTS: 160 breast and formula fed infants less than three months old who present either to clinical or community services and meet Wessel's criteria of crying and/or fussing. INTERVENTION: Oral once-daily Lactobacillus reuteri (1x108 cfu) versus placebo for one month. PRIMARY OUTCOME: Infant crying/fussing time per 24 hours at one month. SECONDARY OUTCOMES: i) number of episodes of infant crying/fussing per 24 hours and ii) infant sleep duration per 24 hours (at 7, 14, 21, 28 days and 6 months); iii) maternal mental health scores, iv) family functioning scores, v) parent quality adjusted life years scores, and vi) intervention cost-effectiveness (at one and six months); and vii) infant faecal microbiota diversity, viii) infant faecal calprotectin levels and ix) Eschericia coli load (at one month only). ANALYSIS: Primary and secondary outcomes for the intervention versus control groups will be compared with t tests and non-parametric tests for continuous data and chi squared tests for dichotomous data. Regression models will be used to adjust for potential confounding factors. Intention-to-treat analysis will be applied. DISCUSSION: An effective, practical and acceptable intervention for infant colic would represent a major clinical advance. Because our trial includes breast and formula-fed babies, our results should generalise to most babies with colic. If cost-effective, the intervention's simplicity is such that it could be widely taken up as a new standard of care in the primary and secondary care sectors. TRIAL REGISTRATION: Current Controlled Trials ISRCTN95287767.
-
ItemPreventing mental health problems in children: the Families in Mind population-based cluster randomised controlled trial(BMC, 2012-06-08)BACKGROUND: Externalising and internalising problems affect one in seven school-aged children and are the single strongest predictor of mental health problems into early adolescence. As the burden of mental health problems persists globally, childhood prevention of mental health problems is paramount. Prevention can be offered to all children (universal) or to children at risk of developing mental health problems (targeted). The relative effectiveness and costs of a targeted only versus combined universal and targeted approach are unknown. This study aims to determine the effectiveness, costs and uptake of two approaches to early childhood prevention of mental health problems ie: a Combined universal-targeted approach, versus a Targeted only approach, in comparison to current primary care services (Usual care). METHODS/DESIGN: Three armed, population-level cluster randomised trial (2010-2014) within the universal, well child Maternal Child Health system, attended by more than 80% of families in Victoria, Australia at infant age eight months.Participants were families of eight month old children from nine participating local government areas. Randomised to one of three groups: Combined, Targeted or Usual care.The interventions comprises (a) the Combined universal and targeted program where all families are offered the universal Toddlers Without Tears group parenting program followed by the targeted Family Check-Up one-on-one program or (b) the Targeted Family Check-Up program. The Family Check-Up program is only offered to children at risk of behavioural problems.Participants will be analysed according to the trial arm to which they were randomised, using logistic and linear regression models to compare primary and secondary outcomes. An economic evaluation (cost consequences analysis) will compare incremental costs to all incremental outcomes from a societal perspective. DISCUSSION: This trial will inform public health policy by making recommendations about the effectiveness and cost-effectiveness of these early prevention programs. If effective prevention programs can be implemented at the population level, the growing burden of mental health problems could be curbed. TRIAL REGISTRATION: ISRCTN61137690.