Dietary Modification or Parental Support in Managing Infantile Colic---Practical Intervention Development and Evaluation

Infantile colic appears to occur in nearly 20% of infants, and its cause is still not completely understood. One etiology may be protein sensitivity with crying as symptom. Some evidences have shown that cow’s milk remove from the diet of breastfeeding mothers or fed colicky infant with hydrolyzed casein formula, the symptom was reduced. Parental support was also proposed as an effective approach to relieve colic. However, results from several systematic reviews indicated that there is no consensus about therapy. Since dietary or counseling intervention, the drug-free managements, are the first choices of parents, this study is aimed to develop a dietary or parental counseling intervention and to test their efficacy in managing infantile colic. This is a 3-year study involving surveys and randomized control trials. The objective of 1st year is to complete a survey aimed to identify potential factor associated with infantile colic and symptom characteristics. 240 eligible colicky and non-colicky mother-infant pairs will be recruited. Information about health, allergy, lifestyle and feeding will be compared between groups, and characteristics of colic symptoms will be reported and analyzed. Significant factors and symptoms related to colic will be applied as observed variables or outcome measures in Year 2 study. In Year 2, a randomized control trial will be conducted to test the efficacy of interventions. Subjects will be classified as exclusively breast-fed or bottle-fed groups before randomly assigned to either dietary modification (maternal hypoallergenic diet for breastfeeding mothers and casein hydrolyzed milk for bottle-fed infants), or parental support, or control subgroup. 240 subjects will be recruited, 40 for each subgroup. Intervention will be implemented for 7 days and 1 follow-up on Day 14. Outcome measures will be the reductions in fussiness, crying, symptom presence, and sleep problem. Results of Year 1 and 2 will help to develop a practical protocol for Year 3. The protocol includes information provided to parents about symptom identification before clinical visit and management after the visit. In Year 3, 400 subjects will be recruited and about 120 colicky subjects will be randomly assigned to either protocol intervention group or to the control group. Number of colicky subjects will depend on the nature of incidence. Both groups will be provided information related to symptoms of colic. Incidence rates will be calculated if subjects from either one of the group search for medical treatment on colic. Reductions in fussiness, crying, symptom presence, and sleep problem will be compared among pre-intervention, post-intervention, and follow-ups at 14th and 21st days for both groups. Results of this study will help to develop a practical intervention to manage infantile colic. Statistical analysis will be done based on study aims.

Project ID:PC10401-0767
External Project ID:MOST103-2314-B182-050-MY3