Status:
COMPLETED
New Chicco Bottles Study
Lead Sponsor:
Sprim Advanced Life Sciences
Collaborating Sponsors:
Artsana S.p.a.
Conditions:
Feeding Behavior
Eligibility:
All Genders
1-10 years
Phase:
NA
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) an...
Detailed 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, co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 12 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2015
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03311282
Start Date
June 12 2014
End Date
January 5 2015
Last Update
October 18 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.