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Retrospective Review of Amino Acid Formula Use at a Children's Center

Retrospective Review of Amino Acid Formula Use at a Children's Center

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03497091
Enrollment
23
Registered
2018-04-13
Start date
2018-06-15
Completion date
2019-01-31
Last updated
2019-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children Requiring Amino Acid-based Formula Tube Feeding, Enteral Feeding Intolerance

Brief summary

This is a retrospective review of data documented in medical records.

Detailed description

This is a retrospective review of data documented in medical records of patients consuming an amino-acid based enteral formula at a pediatric care facility in the United States.

Interventions

Enteral Feeding with an amino acid-based formula

Sponsors

Société des Produits Nestlé (SPN)
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Consuming or with a history of consuming an amino acid-based formula

Exclusion criteria

* Medical records lacking information on consumption of an amino acid-based formula

Design outcomes

Primary

MeasureTime frameDescription
Documented indication for formula useUp to 12 months before formula switchMedical diagnosis

Secondary

MeasureTime frameDescription
Length/height12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switchLength or height (based on age) in centimeters
Formula volume consumption12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switchAverage of 7 days
Body weight12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switchBody weight in kilograms
Stool consistency12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switchAverage of 7 days
Vomiting12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switchAverage of 7 days
Stool frequency12, 6 months prior to formula switch, at formula switch, and 6, 12 months post switchAverage of 7 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026