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Feeding BehaviorStep-UpNCT03311282

New Chicco Bottles Study

A study testing infants bottles in people with Feeding Behavior, run by Sprim Advanced Life Sciences.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 1 day to 10 monthsHealthy volunteers can take part
Conditions the study is for
Feeding Behavior
What is being tested?
infants bottles
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
No sites listed yet
Study dates
12 Jun 2014to 5 Jan 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 10 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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.

Read more

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.

Read the 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.

Being tested
infants bottles
Keywords
breastfeeding, infants, squeezing, breathing
Medical subject headings
Feeding Behavior, Breast Feeding, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • infants bottlesDevice

    Also called Natural Feeling/Natural Fit 0-4m:

    • 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 BottlesDevice

    Also called Natural Feeling/Natural Fit 4-6m:

    • 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 BottlesDevice

    Also called Natural Feeling/Natural Fit 6m+:

    • 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
Study groups in NCT03311282
Study groupRoleWhat they receive
Feeding Bottle 0m+Experimental10 infants aged 0-4 weeks (+/- 7 days): 0-4 m bottle. 0-4 months, 250 ml, 2 angled teats: newborn (also referred to as low flow) and infant (also referred to as medium flow), for infants aged 0-4 weeks (+/- 7 days) / over 9 weeks of participation.
Receives: Device: infants bottles
Feeding Bottle 4m+Experimental10 infants aged 4 months (+/- 10 days): 4-6 m bottle. 4-6 months, 250 ml, non-angled teat), for infants aged 4 months (+/- 10 days) / over 9 weeks of participation.
Receives: Device: Infants Bottles
Feeding Bottle 6m+Experimental10 infants aged 6-10 months (+/- 10 days): 6m+ bottle. 6 months and over, 250 ml, longer teat) for infants aged form 6 to 10 months (+/- 10 days) / over 9 weeks of participation.
Receives: Device: Infants Bottles
exclusively or prevalently breast-fed infants 0m+No intervention10 infants aged 0-4 weeks (+/- 7 days)
exclusively or prevalently breast-fed infants 4m+No intervention10 infants aged 4 months (+/- 10 days)
exclusively or prevalently breast-fed infants 6m+No intervention10 infants aged 6-10 months (+/- 10 days) (at least 2 breastfeeding sessions per day)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Week 2

  2. 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)

    Measured: week 2

  3. 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)

    Measured: week 2

  4. 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)

    Measured: week 2

Secondary outcomes (15)

  1. 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;

    Measured: week 2

  2. 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;

    Measured: week 2

  3. 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.

    Measured: week 5

  4. 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.

    Measured: week9

  5. 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.

    Measured: week 2

  6. 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

    Measured: week 5

  7. 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

    Measured: week 9

  8. 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

    Measured: week 2

  9. Ability of infant to latch onto bottle (10 points Likert scales)

    Ability of infant to latch onto bottle at week 5

    Measured: week 5

  10. 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

    Measured: week 9

  11. Infant comfort (10 points Likert scales)

    Infant comfort during feeding at week 2

    Measured: week 2

  12. 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

    Measured: week 5

  13. 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

    Measured: week 9

  14. 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

    Measured: week 2

  15. 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

    Measured: week 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2017
  2. Study start12 Jun 2014
  3. Primary completion25 Oct 2014
  4. Study completion5 Jan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03311282
Sponsor's protocol ID
Art001
Acronym
Step-Up
Status last verified
Oct 2017
First submitted
4 Oct 2017
Last updated
18 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing infants bottles in people with Feeding Behavior, run by Sprim Advanced Life Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Velocity orbicularis oris (OM) Muscle by means of SLI (time frame: Week 2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03311282.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2017.

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