Study Results
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Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2014-06-12
2015-01-05
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
* 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)
OTHER
NONE
Study Groups
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Feeding Bottle 0m+
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.
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
Feeding Bottle 4m+
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.
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
Feeding Bottle 6m+
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.
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
exclusively or prevalently breast-fed infants 0m+
10 infants aged 0-4 weeks (+/- 7 days)
No interventions assigned to this group
exclusively or prevalently breast-fed infants 4m+
10 infants aged 4 months (+/- 10 days)
No interventions assigned to this group
exclusively or prevalently breast-fed infants 6m+
10 infants aged 6-10 months (+/- 10 days) (at least 2 breastfeeding sessions per day)
No interventions assigned to this group
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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
1 Day
10 Months
ALL
Yes
Sponsors
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Artsana S.p.a.
INDUSTRY
Sprim Advanced Life Sciences
OTHER
Responsible Party
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Other Identifiers
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Art001
Identifier Type: -
Identifier Source: org_study_id