Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00666120

Enrollment

333

Registered

2008-04-24

Start date

2005-06-30

Completion date

2006-04-30

Last updated

2008-04-24

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

Conditions

Healthy Term Infants Solely Formula Fed

Brief summary

To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator. Hypothesize there will be no difference between formula groups.

Interventions

OTHEREnfamil LIPIL with iron

cow's milk based infant formula

OTHERGood Start Supreme with DHA and ARA

partially hydrolzed cow's milk protein

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

4 Days to 18 Days

Healthy volunteers

Yes

Inclusion criteria

* Singleton birth * Term infant at birth * Birth weight of 2500 g (5 lbs 8 oz) or more * 4 - 18 days of age at Study Visit 1

Exclusion criteria

* History of underlying metabolic or chronic disease or congenital malformation * Infant switched formulas more than one time between birth and Study Visit 1 * Known feeding problems at Study Visit 1

Design outcomes

Primary

Measure	Time frame
Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator	60 days

Secondary

Measure	Time frame
Infant temperament	60 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026