New Chicco Bottles Study
Condition: Feeding Behavior
Study type: Interventional

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.
    

Intervention name(s): infants bottles; Infants Bottles; Infants Bottles
Intervention type(s): Device; Device; Device
Intervention description(s): 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; 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; 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
Other intervention name(s): Natural Feeling/Natural Fit 0-4m:; Natural Feeling/Natural Fit 4-6m:; Natural Feeling/Natural Fit 6m+:
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Treatment groups: bottle-fed infants
Group 1: 10 infants aged 0-4 weeks (+/- 7 days): 0-4 m bottle
Group 2: 10 infants aged 4 months (+/- 10 days): 4-6 m bottle
Group 3: 10 infants aged 6-10 months (+/- 10 days): 6m+ bottle Control groups: exclusively or prevalently breast-fed infants
Group 4: 10 infants aged 0-4 weeks (+/- 7 days)
Group 5: 10 infants aged 4 months (+/- 10 days)
Group 6: 10 infants aged 6-10 months (+/- 10 days) (at least 2 breastfeeding sessions per day)
Number of subjects enrolled and allocated: 61 healthy infants, both male and female as follows:
Treatment groups: bottle-fed infants
Group 1: 11 infants aged 0-4 weeks (+/- 7 days): 0-4 m bottle
Group 2: 10 infants aged 4 months (+/- 10 days): 4-6 m bottle
Group 3: 10 infants aged 6-10 months (+/- 10 days): 6m+ bottle Control groups: exclusively or prevalently breast-fed infants
Group 4: 10 infants aged 0-4 weeks (+/- 7 days)
Group 5: 10 infants aged 4 months (+/- 10 days)
Masking: None (Open Label)
Primary purpose: Other
Keywords: breastfeeding; infants; squeezing; breathing