New Chicco Bottles Study

NCT03311282 | Completed

• 1 other identifier: Art001
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Feeding Behavior

Keywords

breastfeeding; infants; squeezing; breathing

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (15)

• ml/minute milk intake during an interval of 15 minutes

  week 2

• oxygen saturation

  week 2

• infant colic scale

  week 5

• infant colic scale

  week9

• overall product satisfaction (10 points likert scales)

  week 2

Study Arms (6)

Feeding Bottle 0m+

EXPERIMENTAL

10 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.

Device: infants bottles

Feeding Bottle 4m+

EXPERIMENTAL

10 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.

Device: Infants Bottles

Feeding Bottle 6m+

EXPERIMENTAL

10 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.

Device: Infants Bottles

exclusively or prevalently breast-fed infants 0m+

NO INTERVENTION

10 infants aged 0-4 weeks (+/- 7 days)

exclusively or prevalently breast-fed infants 4m+

NO INTERVENTION

10 infants aged 4 months (+/- 10 days)

exclusively or prevalently breast-fed infants 6m+

NO INTERVENTION

10 infants aged 6-10 months (+/- 10 days) (at least 2 breastfeeding sessions per day)

Interventions

Infants Bottles DEVICE

* 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

Also known as: Natural Feeling/Natural Fit 0-4m:

Feeding Bottle 0m+

Eligibility Criteria

• Age: 1 Day - 10 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sprim Advanced Life Sciences: lead
• Artsana S.p.a.: collaborator

MeSH Terms

Conditions

Feeding Behavior; Breast Feeding; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was a prospective, open-label, monocentric, interventional clinical study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 17, 2017
• Study Start: June 12, 2014
• Primary Completion: October 25, 2014
• Study Completion: January 5, 2015
• Last Updated: October 18, 2017

Record last verified: 2017-10