Feeding Behavior Clinical Trial
— Step-UpOfficial title:
Evaluation of the New Chicco Breast-like and Evolutive Feeding Bottles on Physiological Feeding Parameters and Colic-like Symptoms in Infants
Verified date | October 2017 |
Source | Sprim Advanced Life Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 61 |
Est. completion date | January 5, 2015 |
Est. primary completion date | October 25, 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 10 Months |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sprim Advanced Life Sciences | Artsana S.p.a. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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; | week 2 | |
Secondary | 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; | week 2 | |
Secondary | 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. |
week 5 | |
Secondary | 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. |
week9 | |
Secondary | 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. | week 2 | |
Secondary | 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 | week 5 | |
Secondary | 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 | week 9 | |
Secondary | 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 | week 2 | |
Secondary | Ability of infant to latch onto bottle (10 points Likert scales) | Ability of infant to latch onto bottle at week 5 | week 5 | |
Secondary | 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 | week 9 | |
Secondary | Infant comfort (10 points Likert scales) | Infant comfort during feeding at week 2 | week 2 | |
Secondary | 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 | week 5 | |
Secondary | 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 | week 9 | |
Secondary | 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 | week 2 | |
Secondary | 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 | week 2 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04502979 -
Learning to Love Mealtime Together
|
N/A | |
Completed |
NCT03334266 -
Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months
|
N/A | |
Completed |
NCT03651258 -
Facilitate the Transition From Passive Feeding to Active Feeding in Preterm Infants Through Early Play
|
||
Completed |
NCT05992753 -
Mothers' Breast Milk Expression Experiences, Infant Feeding Attitudes and Perceived Social Support Levels
|
||
Completed |
NCT03332108 -
Novel Approach To Improving Lactation Support With Mobile Health Technology
|
N/A | |
Completed |
NCT03941392 -
Nutritional Study in Spanish Pediatric Population
|
||
Completed |
NCT03949543 -
The Timing of Main Meal Consumption Effect on Gut Microbiota and Host
|
N/A | |
Not yet recruiting |
NCT05059574 -
Breast Crawling,Breastfeeding Success and Mothers' Attitudes to Feeding Their Babies
|
N/A | |
Completed |
NCT03242863 -
Effect of Varying Proportions of Low and High Energy Dense Foods Over 5 Days in Preschool Children
|
N/A | |
Completed |
NCT03127579 -
Family Meal Duration and Children's Eating Behavior
|
N/A | |
Completed |
NCT02996422 -
Appalachians Together Restoring the Eating Environment: Improving Healthy Diet in Rural Appalachian Kentucky
|
N/A | |
Enrolling by invitation |
NCT03755999 -
A Cue-based Developmental Approach Toward the Preterm Infants During Feeding Transition Period
|
N/A | |
Recruiting |
NCT03439618 -
Comparison of Time-restricted Feeding and Continuous Feeding in Critically Ill Patients
|
N/A | |
Completed |
NCT03488680 -
Effectiveness of Behavior Change Communication in Improving Feeding Practices, Nutritional and Health Status of Infants
|
N/A | |
Recruiting |
NCT04960969 -
The Effects of Time-Restricted Eating Model
|
N/A | |
Completed |
NCT02930642 -
Food Insecurity, Obesity, and Impulsive Food Choice
|
N/A | |
Completed |
NCT03926065 -
Variations in Palatability and Portion Size of Vegetables on Meal Intake of Preschool Children
|
N/A | |
Completed |
NCT03886428 -
The Influence of Satiation Measures on the Portion Size Effect
|
N/A | |
Completed |
NCT03025815 -
Effects of the Oral Stimulation Program in Extreme Preterm Infants
|
N/A | |
Completed |
NCT02347527 -
Neuronal and Behavioral Effects of Implicit Priming in Obese Individuals
|
N/A |