New Chicco Bottles Study

Feeding Behavior Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03311282
• Other study ID #: Art001
• Status: Completed
• Phase: N/A
• First received: October 4, 2017
• Last updated: October 17, 2017
• Start date: June 12, 2014
• Est. completion date: January 5, 2015

Study information

• Verified date: October 2017
• Source: Sprim Advanced Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 5, 2015
• Est. primary completion date: October 25, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 10 Months

Eligibility

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

Related Conditions & MeSH terms

• Feeding Behavior

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sprim Advanced Life Sciences	Artsana S.p.a.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Velocity orbicularis oris (OM) Muscle by means of SLI	To assess the orbicularis oris muscle (OM) and the perioral muscles (masseter, temporalis and buccinator muscles - MM, TM and BM) activity during breast- or bottle-feeding through SLI of the face during a single feeding session considering 3 treatment groups + 3 comparison groups: Treatment groups: bottle-fed infants; Group 1: age 0-4 weeks (+/- 7 days): 0-4 m bottle; Group 2: age 4 months (+/- 10 days): 4-6 m bottle; Group 3: age 6-10 months (+/- 10 days): 6m+ bottle Control groups: exclusively or prevalently breast-fed infants; Group 4: age 0-4 weeks (+/- 7 days); Group 5: age 4 months (+/- 10 days); Group 6: age 6-10 months (+/- 10 days) (at least 2 breastfeeding sessions per day)	Week 2
Primary	Mean Velocity masseter MM Muscle by means of SLI	To assess the orbicularis oris muscle (OM) and the perioral muscles (masseter, temporalis and buccinator muscles - MM, TM and BM) activity during breast- or bottle-feeding through SLI of the face during a single feeding session considering 3 treatment groups + 3 comparison groups: Treatment groups: bottle-fed infants; Group 1: age 0-4 weeks (+/- 7 days): 0-4 m bottle; Group 2: age 4 months (+/- 10 days): 4-6 m bottle; Group 3: age 6-10 months (+/- 10 days): 6m+ bottle Control groups: exclusively or prevalently breast-fed infants; Group 4: age 0-4 weeks (+/- 7 days); Group 5: age 4 months (+/- 10 days); Group 6: age 6-10 months (+/- 10 days) (at least 2 breastfeeding sessions per day)	week 2
Primary	Mean Velocity Temporalis Muscle by means of SLI	To assess the orbicularis oris muscle (OM) and the perioral muscles (masseter, temporalis and buccinator muscles - MM, TM and BM) activity during breast- or bottle-feeding through SLI of the face during a single feeding session considering 3 treatment groups + 3 comparison groups: Treatment groups: bottle-fed infants; Group 1: age 0-4 weeks (+/- 7 days): 0-4 m bottle; Group 2: age 4 months (+/- 10 days): 4-6 m bottle; Group 3: age 6-10 months (+/- 10 days): 6m+ bottle Control groups: exclusively or prevalently breast-fed infants; Group 4: age 0-4 weeks (+/- 7 days); Group 5: age 4 months (+/- 10 days); Group 6: age 6-10 months (+/- 10 days) (at least 2 breastfeeding sessions per day)	week 2
Primary	Mean Velocity Buccinator Muscle by means of SLI	To assess the orbicularis oris muscle (OM) and the perioral muscles (masseter, temporalis and buccinator muscles - MM, TM and BM) activity during breast- or bottle-feeding through SLI of the face during a single feeding session considering 3 treatment groups + 3 comparison groups: Treatment groups: bottle-fed infants; Group 1: age 0-4 weeks (+/- 7 days): 0-4 m bottle; Group 2: age 4 months (+/- 10 days): 4-6 m bottle; Group 3: age 6-10 months (+/- 10 days): 6m+ bottle Control groups: exclusively or prevalently breast-fed infants; Group 4: age 0-4 weeks (+/- 7 days); Group 5: age 4 months (+/- 10 days); Group 6: age 6-10 months (+/- 10 days) (at least 2 breastfeeding sessions per day)	week 2
Secondary	ml/minute milk intake during an interval of 15 minutes	To evaluate feeding efficiency (ml/minute milk intake for 15 minutes) during a single feeding session of breast- or bottle-feeding considering each group; week 2;	week 2
Secondary	oxygen saturation	To evaluate oxygen saturation through pulse oximetry during a single feeding session of breast- or bottle-feeding considering 3 treatment groups + 3 comparison groups (1, 2, 3, 4, 5, 6); this evaluation was be done at week 2;	week 2
Secondary	infant colic scale	To evaluate colic-like symptoms over 9 weeks considering breast- or bottle-feeding groups in 0 to 4 weeks infants only (groups 1 and 4), through the validated Infant Colic Scale at week 5.; The following items were considered: Cow's milk/soy protein allergy intolerance: Max score 12 Min score 2; Immature gastrointestinal system Max score 24 Min score 4; Immature central nervous system Max score 48 Min score 8; Difficult infant temperament Max score 24 Min score 4; Parent infant interaction/Problem infant Max score 24 Min score 4; Total score Max score 132 Min score 22 The difference between the study groups were evaluated. The scale was used to evaluate a possible difference between bottle- and breastfed infants, there's no "better" or "worse" outcome. Subscales are summed to compute a total score.	week 5
Secondary	infant colic scale	To evaluate colic-like symptoms over 9 weeks considering breast- or bottle-feeding groups in 0 to 4 weeks infants only (groups 1 and 4), through the validated Infant Colic Scale at week 9.; The following items were considered: Cow's milk/soy protein allergy intolerance: Max score 12 Min score 2; Immature gastrointestinal system Max score 24 Min score 4; Immature central nervous system Max score 48 Min score 8; Difficult infant temperament Max score 24 Min score 4; Parent infant interaction/Problem infant Max score 24 Min score 4; Total score Max score 132 Min score 22 The difference between the study groups were evaluated. The scale was used to evaluate a possible difference between bottle- and breastfed infants, there's no "better" or "worse" outcome. Subscales are summed to compute a total score.	week9
Secondary	overall product satisfaction (10 points likert scales)	Overall product satisfaction at week 2. It is assessed on 0 to 10 points Likert scale; minimum value is 0, maximum is 10, corresponding to minimum and maximum satisfaction. The better outcome corresponds to a score equal to 10.	week 2
Secondary	overall product satisfaction (10 points likert scales)	Overall product satisfaction at week 5. It is assessed on 0 to 10 points Likert scale; minimum value is 0, maximum is 10, corresponding to minimum and maximum satisfaction. The better outcome corresponds to a score equal to 10	week 5
Secondary	overall product satisfaction (10 points Likert scales)	Overall product satisfaction at week 9. It is assessed on 0 to 10 points Likert scale; minimum value is 0, maximum is 10, corresponding to minimum and maximum satisfaction. The better outcome corresponds to a score equal to 10	week 9
Secondary	Ability of infant to latch onto bottle (10 points Likert scales)	Ability of infant to latch onto bottle at week 2. It is assessed on 0 to 10 points Likert scale; minimum value is 0, maximum is 10, corresponding to minimum and maximum satisfaction. The better outcome corresponds to a score equal to 10	week 2
Secondary	Ability of infant to latch onto bottle (10 points Likert scales)	Ability of infant to latch onto bottle at week 5	week 5
Secondary	Ability of infant to latch onto bottle (10 points Likert scales)	Ability of infant to latch onto bottle at week 9. It is assessed on 0 to 10 points Likert scale; minimum value is 0, maximum is 10, corresponding to minimum and maximum satisfaction. The better outcome corresponds to a score equal to 10	week 9
Secondary	Infant comfort (10 points Likert scales)	Infant comfort during feeding at week 2	week 2
Secondary	Infant comfort (10 points Likert scales)	Infant comfort during feeding at week 5. It is assessed on 0 to 10 points Likert scale; minimum value is 0, maximum is 10, corresponding to minimum and maximum satisfaction. The better outcome corresponds to a score equal to 10	week 5
Secondary	Infant comfort (10 points Likert scales)	Infant comfort during feeding at week 9. It is assessed on 0 to 10 points Likert scale; minimum value is 0, maximum is 10, corresponding to minimum and maximum satisfaction. The better outcome corresponds to a score equal to 10	week 9
Secondary	Ease of use by infant (10 points Likert scales)	Ease of use by infant at week 2. It is assessed on 0 to 10 points Likert scale; minimum value is 0, maximum is 10, corresponding to minimum and maximum satisfaction. The better outcome corresponds to a score equal to 10	week 2
Secondary	Immediate acceptance by the infant (10 points Likert scales)	Immediate acceptance by the infant at week 2. It is assessed on 0 to 10 points Likert scale; minimum value is 0, maximum is 10, corresponding to minimum and maximum satisfaction. The better outcome corresponds to a score equal to 10	week 2