New Chicco Bottles Study

NCT03311282 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2017-10-18

No results posted yet for this study

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

Interventions

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

DEVICE

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

DEVICE

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

Sponsors & Collaborators

  • Artsana S.p.a.

    collaborator INDUSTRY
  • Sprim Advanced Life Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
10 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-12
Primary Completion
2014-10-25
Completion
2015-01-05

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03311282 on ClinicalTrials.gov