NCT03311282

New Chicco Bottles Study

Evaluation of the New Chicco Breast-like and Evolutive Feeding Bottles on Physiological Feeding Parameters and Colic-like Symptoms in Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Sprim Advanced Life Sciences · Academic / Other
• Sex: All
• Age: 1 Day – 10 Months
• Healthy volunteers: Accepted

Summary

Breastfeeding is recommended as the ideal form of nutrition for newborns and infants at least for the first 6 months of life by several Institutions such as the American Academy of Pediatrics (AAP) and the World Health Organization (WHO). When breastfeeding is not possible or not desirable, bottle-feeding, in most cases using a proper infant formula, is the right alternative. Both facial and cranial growth and development rely on genetic and external stimuli; the latter are provided also by activities of sucking, swallowing and chewing. Considering this, it is important to show the differences between the activities of the muscles (masseter, temporalis and buccinator) in charge of sucking during breastfeeding or bottle-feeding. The activities of the muscles were evaluated through SLI, which consists of the assessment of muscle functioning by analyzing the displacement of a defined point on a given muscle. This displacement is tracked over time with respect to a fixed frame of reference, thus providing velocity data (i.e. speed) for a certain point on the muscle during muscle contraction. The use of SLI allowed us to determine the activity of oral muscles on the different types of feeding and to compare their strength and activity. Principal aims of the present study was to assess the activity of the orbicularis oris muscle (OM) and of the masseter, temporalis and buccinator muscles (MM, TM and BM) (i.e. the muscles in charge of sucking during breastfeeding) during breastfeeding and bottle-feeding by means of SLI. The new Chicco feeding bottles Natural Feeling (Natural Fit) 0m+, 4m+ and 6m+ were used according to the age of the infants. Moreover, the following parameters were evaluated comparing breastfeeding and bottle-feeding: feeding efficiency (measured as ml/minute milk intake considering an interval of 15 minutes) and oxygen saturation during feeding (assessed by pulse oximetry). Moreover colic-like symptoms over 9 weeks (0 to 4 weeks infant only) were evaluated through the Infant Colic Scale.

Detailed description

By means of SLI technique positive preliminary results as regards comparison between bottle feeding with the New Chicco Bottles and breastfeeding were reached; these results allow to conclude that, considering feeding features related to growth and development, bottle-feeding with the new Chicco bottles can biomimic the suction muscular dynamics of breastfeeding. A proper growth is confirmed in bottle-feeding groups also by means of evaluations of growth parameters, and it is guaranteed by the evaluation of the oxygen saturation during feeding, that is similar among groups. As regards evaluation of colic underlying causes in infants ages 0-4 weeks it is possible to state that no differences were found in bottle-fed and breastfed infants: given the lack of differences between the groups, whichever the underlying reason for colic symptomatology could exist, it is possible to infer that using one or the other kind of feeding does not have an impact on symptoms, or had a minor one. As regards the product satisfaction evaluated comparing the bottle-fed groups positive results were reached in all the evaluation, at V2, Week 5 and Week 9, reaching always a mean score \> 8. Notwithstanding the positive results above outlined a confirmatory study, envisaging a bigger sample size, it is advisable, to confirm and emphasize the results already achieved. For each trial participant the adverse events/serious adverse events occurrences and a brief clinical examination were assessed during Visits. No special or unusual features of the safety evaluations were found.

Conditions

• Feeding Behavior

Interventions

Type	Name	Description
DEVICE	infants bottles	* angled/inclined teat that remains full of milk throughout the feeding to prevent the risk of air ingestion, gassy colic, hiccups and regurgitation and to keep the infant's neck in the right position; * extra-large, soft and rounded base to ensure maximum simulation of the maternal breast and a wide latch on for a correct suckling motion * flexors at the base to enhance elasticity and flexibility of the teat
DEVICE	Infants Bottles	* large, rounded and soft teat to ensure maximum simulation of the maternal breast and a wide latch on for a correct suckling motion * non-inclined shape of the teat ideal from 4 months onwards, when the colic episodes have subsided and infant has more control of the neck. * flexors at the base to enhance elasticity and flexibility of the teat
DEVICE	Infants Bottles	* teat with less rounded base to guarantee tighter lip support, which helps the "sucking" motion. * flexors at the base to enhance elasticity and flexibility of the teat

Timeline

• Start date: 2014-06-12
• Primary completion: 2014-10-25
• Completion: 2015-01-05
• First posted: 2017-10-17
• Last updated: 2017-10-18