New Chicco Bottles Study (Step-Up)

Sprim Advanced Life Sciences

Status

Completed

Conditions

Feeding Behavior

Treatments

Device: infants bottles

Device: Infants Bottles

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03311282

Art001

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 patients

Sex

All

Ages

1 day to 10 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

61 participants in 6 patient groups

Feeding Bottle 0m+

Experimental group

Description:

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.

Treatment:

Device: infants bottles

Feeding Bottle 4m+

Experimental group

Description:

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.

Treatment:

Device: Infants Bottles

Feeding Bottle 6m+

Experimental group

Description:

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.

Treatment:

Device: Infants Bottles

exclusively or prevalently breast-fed infants 0m+

No Intervention group

Description:

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

exclusively or prevalently breast-fed infants 4m+

No Intervention group

Description:

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

exclusively or prevalently breast-fed infants 6m+

No Intervention group