Clinical trial NCT03311282: New Chicco Bottles Study
Official title: Evaluation of the New Chicco Breast-like and Evolutive Feeding Bottles on Physiological Feeding Parameters and Colic-like Symptoms in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Behavior
Keywords: breastfeeding
infants
squeezing
breathing
Lead sponsor: Sprim Advanced Life Sciences
Sponsor class: OTHER
Collaborators: name: Artsana S.p.a.
First posted: 2017-10-17
Enrollment: 61
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Male and female infants aged 0 to 10 months according to the following:

Group 1: age 0-4 weeks (+/- 7 days) Group 2: age 4 months (+/- 10 days) Group 3: age 6-10 months (+/- 10 days) Group 4: age 0-4 weeks (+/- 7 days) Group 5: age 4 months (+/- 10 days) Group 6: age 6-10 months (+/- 10 days)

* Infants exclusively or prevalently breast- or bottle-fed
* Full-term infants (≥ 37 weeks of gestation) with APGAR at birth (5 min) ≥ 8 by parent report
* Birth weight ≥ 2.5 kg by parent report
* Capability of the parents / legal guardians, according to Investigator's opinion, to fully comprehend the nature of the study
* Parents / legal guardians' written consent to the study and willingness to comply with study procedures

Exclusion Criteria:

* Birth defect, injury or health condition that interferes with sucking, feeding or breathing
* Any medical condition or disease that may affect subject safety or confound study results, including cardiac or neurological defects
* Infants born from twin or multiple pregnancy
* Any other condition that, in the Investigator's opinion, may preclude the subject's ability to safely complete the trial
* Parents / legal guardians uncooperative and/or non-compliant according to Investigator's opinion

Primary outcomes:
measure: Mean Velocity orbicularis oris (OM) Muscle by means of SLI
timeFrame: Week 2
measure: Mean Velocity masseter MM Muscle by means of SLI
timeFrame: week 2
measure: Mean Velocity Temporalis Muscle by means of SLI
timeFrame: week 2
measure: Mean Velocity Buccinator Muscle by means of SLI
timeFrame: week 2
Secondary outcomes:
measure: ml/minute milk intake during an interval of 15 minutes
timeFrame: week 2
measure: oxygen saturation
timeFrame: week 2
measure: infant colic scale
timeFrame: week 5
measure: infant colic scale
timeFrame: week9
measure: overall product satisfaction (10 points likert scales)
timeFrame: week 2
measure: overall product satisfaction (10 points likert scales)
timeFrame: week 5
measure: overall product satisfaction (10 points Likert scales)
timeFrame: week 9
measure: Ability of infant to latch onto bottle (10 points Likert scales)
timeFrame: week 2
measure: Ability of infant to latch onto bottle (10 points Likert scales)
timeFrame: week 5
measure: Ability of infant to latch onto bottle (10 points Likert scales)
timeFrame: week 9
measure: Infant comfort (10 points Likert scales)
timeFrame: week 2
measure: Infant comfort (10 points Likert scales)
timeFrame: week 5
measure: Infant comfort (10 points Likert scales)
timeFrame: week 9
measure: Ease of use by infant (10 points Likert scales)
timeFrame: week 2
measure: Immediate acceptance by the infant (10 points Likert scales)
timeFrame: week 2
Other outcomes:
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