מחקר קליני - קוליק

Examination of the effect of B-free baby bottles on infant colic

Introduction

Infantile Colic is a broad term which is defined by its symptoms rather than a particular cause. Despite its benign, natural course, colic is a significant problem in infants and imparts a psychological, emotional, and physical burden to parents (Alexandrovich, Rakovitskaya, Kolmo, Sidorova, & Shushunov, 2003). In general, colic starts around three weeks of age, reaches its peak at approximately six weeks and then usually lessens around three or four months of age (Wessel, Cobb, Jackson, Harris Jr, & Detwiler, 1954). A baby is described as having colic by episodes of uncontrollable, extended crying over three hours a day and at least three days a week, and is distinguished by crying which is 'paroxysmal'-that is, intense and different in type from normal fussing and crying (James-Roberts, 1999). Colic crying has been typically described as a high-pitched scream, occurring mainly in the late afternoon or evening but it may occur at other times. Characteristically, an infant’s knees are drawn up to the abdomen, face is flushed, fists are clenched, flatus is expelled, and there is minimal response to attempts at soothing (Balon, 1997).

Colic is believed to affect about 20% of otherwise healthy well-fed babies (Forsyth, Leventhal, & McCarthy, 1985; Keefe & Froese-Fuetz, 1991; Rautava, Helenius, & Lehtonen, 1993). Several researchers have shown that colic is not related to gender, race, or socioeconomic class (Baildam et al., 1995; Ellett & Marsha, 2003; James Roberts & Halil, 1991; St hlberg & Savilahti, 1986). The cause of infant colic is likely to be multi-factorial (Ellett & Marsha, 2003), with suggested reasons related to feeding difficulties (Miller-Loncar, Bigsby, High, Wallach, & Lester, 2004) and to maternal smoking (Shenassa & Brown, 2004), among others. The etiology is unclear but gastrointestinal factors and allergy to cow's milk protein have been suggested as possible causes (Lucassen et al., 1998). Another suggestion is that colic is a behavioral condition resulting from unfavorable parent–infant interaction (Landgren, Kvorning, & Hallstr m, 2010).

            Regardless of whether the one true underlying cause of infant colic can be identified, studies have shown that a vented baby bottle will help alleviate a baby’s discomfort. One study showed that when compared with conventional bottles, vented bottles decreased the time infants spent crying by about 66 minutes per day, and the time they spent fussing by 48 minutes per day (Brown & Magnuson, 2000). Another study that compared using vented bottles (treatment group) to non-vented bottles (control group) looked at three indications to colic symptoms: infants crying, fussing and the time they spent sleeping (Cirgin Ellett & Perkins, 2006). In the control group infants crying time per day decreased by 12.7 minutes during the experiment period of 14 days, while in the treatment group a decrease of 90.5 minutes was recorded. In the control group infants fussing time per day increased by 4.7 minutes during the experiment period of 14 days, while in the treatment group a decrease of 50.2 minutes was recorded. In the control group infants sleeping time per day increased by 14.3 minutes during the experiment period of 14 days, while in the treatment group an increase of 90.5 minutes was recorded. All the statistically significant differences for crying (p=0.01), fussing (p<0.01) and sleeping time (p=0.56) proved the advantage of using the vented bottles in reducing colic symptoms. Another study revealed that with vented bottles the mean colic symptom duration was 31 minutes as opposed to 52 minutes with the non-vented bottle (Lucas & St James-Roberts, 1998).

B-free has produced bottles with a unique venting system over the past decade. Consistent and frequent follow-up with customers through written and telephone surveys has provided evidence of the significant advantage of B-free bottles over all competitors in many colic related aspects, including babies' levels of comfort.

In order to examine the effects of using B-free bottles in reducing colic symptoms, we located families with babies who had such symptoms and monitored them for a period of two weeks. The control group kept using their regular baby bottles for two weeks and the experimental group babies switched to B-free bottles. Diagnosis of colic is possible mainly by behavioral symptoms, yet some symptoms such as crying are identical in both colic and non colic infants (Wessel, et al., 1954). In light of this, we constructed a questionnaire relating to seven different symptoms indicating colic, thereby avoiding misdiagnosing the participating infants. Parents of both groups filled three identical questionnaires, at the beginning, after one week and after two weeks of the study.  

We were able to show a significant reduction in all colic symptoms for the experimental group babies within seven days after switching to B-free bottles, and even more so after an additional week. We were able to demonstrate the advantage of using the narrow tube aid to the venting system.

Subjects and Methods

Eighty six healthy Israeli newborns, ages 2-12 weeks participated in this study between the months of June and September 2011. All selected babies had been using various brands of bottles, none of which were B-free bottles. The babies were selected after they were diagnosed as having colic symptom according to their parents' statements. The diagnostic instrument was a questionnaire where the baby’s parents had to rank on a Likert type (ranging from 1 as very rarely to 5 as very frequently) scale the baby’s following symptoms: 1. Baby crying; 2. Baby folding legs in direction of the stomach; 3. Baby frowning, showing discomfort; 4. Baby’s face color changing to red; 5. Baby clenching fists; 6. Baby looks in pain; 7. Baby suffering sudden pain spasms. Only babies with an average of more than 3.5 for all symptoms entered the survey. The babies were divided to three groups: an experimental1 group of 30 babies, an experimental2 group of 27 babies and a control group of 29 babies. After completing the first questionnaire, babies in the experimental1 group began using the B-free bottles with narrow tube, babies in the experimental2 group began using the B-free bottles without narrow tube while the control group babies continued using the same bottles. All of the control group bottles had a venting system that was different from the one in the B-free bottles. Parents filled two additional questionnaires after one week and after two weeks. The assumption that colic symptoms remain for weeks and months in the average baby is well documented (Keefe& Froese-Fuetz, 1991; Balon, 1997; Lucas& St James-Roberts, 1998 and many more). Besides the colic symptoms data, we have also collected for each baby data concerning the baby’s age, mother’s age, number of siblings, the feeding formula (including pumped breast milk), the feeding volume and the number of feedings per day.

Internal consistency reliability (Alpha Cronbach) for the total scale was 0.92 in the experimental1 (with narrow tube) group, 0.94 in the experimental2 (without narrow tube) group and 0.89 in the control group. It ranged for the subscales from 0.75 to 0.95 in the experimental1 group, from 0.82 to 0.96 in the experimental2 group and from 0.6 to 0.91 in the control group.

Results

No significant correlation was found between the colic symptoms of all 86 babies and the age of the mother (r=0.06, p=0.58), number of siblings (r=-0.02, p=0.83), and the baby’s age (r=-0.01, p=0.36) at the beginning of the trial. The type of formula ( p=0.33) and the type of the bottle used ( p=0.29) at the beginning of the trial had no significant effect on the baby’s colic symptoms.

 Table 1 presents the proportion of babies that showed an average reduction in colic symptoms and increase in comfort in the three groups and a group of all B-free users (experimental1+2).

Table 1: Proportion of babies showing an average reduction in colic symptoms in the three groups. Experimental1- with narrow tube; Experimental2- without narrow tube; experimental1+2 - all B-free users.

Table 2 shows the averages of answers to the 7 questions concerning colic symptoms at three stages: before using the bottle, after one week of use and after two weeks of use, in the control, experimental1and experimental2 groups.

Table 2: The averages of answers to the 7 questions concerning colic symptoms for each group at the beginning of the trial (top), after one week (middle) and after two weeks (bottom).

Figure 1 presents the averages of the three groups at the different stages of the trial: at the beginning, seven days later and fourteen days later. 

Figure 1: The averages of the control (blue), experimental1 (Exp.1 - red) and experimental2 (Exp.2 – green)) groups at the different stages of the trial (beginning, after 7 days and after 14 days).

No significant differences between the three groups in each of the 7 questions were found in the first questionnaire at the beginning of the trial (K.W., p>0.2 in all the comparisons). No significant differences between the three groups were found when comparing the average of all the questions in the first questionnaire between the three groups (K.W., p=0.95).

A significant difference between the three groups was observed 7 days after the trial beginning (K.W., p<0.001). Post-hoch multiple comparisons showed significant differences between the control and experimental1 group (p< 0.001), between the control and experimental2 group (p< 0.01) and between the experimental1 and experimental2 group (p< 0.01).

A significant difference between the three groups was observed also 14 days after the trial beginning (K.W., p<0.001). Post-hoch multiple comparisons showed significant differences between the control and experimental1 group (p< 0.001), between the control and experimental2 group (p< 0.001) and no significant difference between the experimental1 and experimental2 group (p=0.1).

Conclusions

This study has indicated two major links. The first is that using the B-free bottle when feeding infants significantly reduces all the relevant symptoms of colic and improves the baby’s level of comfort. This reduction is independent of the feeding formula, which bottle was used previously prior to the study, or any other characteristics (e.g., the baby’s age, mother’s age, number of siblings, number of daily feedings etc.). The improvement was evident for varying ages and was noticeable after the first week in 80.6% of the babies, and in 86% of the babies the colic symptoms were further reduced in the second week of the study. Only 5.3% of the babies remained with the same level of the colic symptoms as the beginning of the study. No such improvement was recorded in the control group. We therefore conclude that switching colicky babies to B-free bottles significantly helps in the reduction of colic symptoms. The second finding indicates that the use of the narrow tube further increases the effect of reducing colic symptoms. From an average score of 4.4 in both experimental groups at the beginning of the study, there was an improvement to a score of 2.9 for babies that were fed with the narrow tube, while the other group (without the tube) had a score of 3.7. After 14 days the score for the narrow tube users was 2.3 as compared to 2.7 for the no tube users. We therefore conclude that switching colicky babies to B-free bottles with narrow tubes enhances the effect of reducing colic symptoms.

References:

Alexandrovich, I., Rakovitskaya, O., Kolmo, E., Sidorova, T., & Shushunov, S. (2003). The effect of fennel (Foeniculum vulgare) seed oil emulsion in infantile colic: a randomized, placebo-controlled study. Alternative therapies in health and medicine, 9(4), 58-61.

Baildam, E., Wilier, V., Ward, B., Bannister, R., Bamford, F., & Moore, W. (1995). Duration and pattern of crying in the first year of life. Developmental Medicine & Child Neurology, 37(4), 345-353.

Balon, A. (1997). Management of infantile colic. American family physician, 55(1), 235.

Brown, C. E., & Magnuson, B. (2000). On the physics of the infant feeding bottle and middle ear sequela: ear disease in infants can be associated with bottle feeding. International journal of pediatric otorhinolaryngology, 54(1), 13-20.

Cirgin Ellett, M. L., & Perkins, S. M. (2006). Examination of the effect of Dr. Brown's natural flow baby bottles on infant colic. Gastroenterology Nursing, 29(3), 226.

Ellett, C., & Marsha, L. (2003). What Is Known About Infant Colic? Gastroenterology Nursing, 26(2), 60.

Forsyth, B., Leventhal, J., & McCarthy, P. (1985). Mothers' perceptions of problems of feeding and crying behaviors. A prospective study. American journal of diseases of children (1960), 139(3), 269.

James-Roberts, I. S. (1999). What is distinct about infants’“colic” cries? Archives of disease in childhood, 80(1), 56.

James Roberts, I. S., & Halil, T. (1991). Infant crying patterns in the first year: normal community and clinical findings. Journal of Child Psychology and Psychiatry, 32(6), 951-968.

Keefe, M. R., & Froese-Fuetz, A. (1991). Living with an irritable infant: maternal perspectives. MCN: The American Journal of Maternal/Child Nursing, 16(5), 255.

Landgren, K., Kvorning, N., & Hallstr m, I. (2010). Acupuncture reduces crying in infants with infantile colic: a randomised, controlled, blind clinical study. Acupuncture in Medicine, 28(4), 174.

Lucas, A., & St James-Roberts, I. (1998). Crying, fussing and colic behaviour in breast-and bottle-fed infants. Early human development, 53(1), 9-18.

Lucassen, P., Assendelft, W., Gubbels, J., Van Eijk, J., Van Geldrop, W., & Neven, A. K. (1998). Effectiveness of treatments for infantile colic: systematic review. Bmj, 316(7144), 1563.

Miller-Loncar, C., Bigsby, R., High, P., Wallach, M., & Lester, B. (2004). Infant colic and feeding difficulties. Archives of disease in childhood, 89(10), 908.

Rautava, P., Helenius, H., & Lehtonen, L. (1993). Psychosocial predisposing factors for infantile colic. British Medical Journal, 307(6904), 600.

Shenassa, E. D., & Brown, M. J. (2004). Maternal smoking and infantile gastrointestinal dysregulation: the case of colic. Pediatrics, 114(4), e497.

St hlberg, M., & Savilahti, E. (1986). Infantile colic and feeding. Archives of disease in childhood, 61(12), 1232.

Wessel, M. A., Cobb, J. C., Jackson, E. B., Harris Jr, G. S., & Detwiler, A. C. (1954). Paroxysmal fussing in infancy, sometimes called" colic". Pediatrics, 14(5), 421.