Feeding Behavior Clinical Trial
Official title:
Evaluation of the New Chicco Breast-like and Evolutive Feeding Bottles on Physiological Feeding Parameters and Colic-like Symptoms in Infants
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.
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.
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