Assessment of Growth of Infants Fed a New Formula

Infant Nutrition Clinical Trial

Official title:

Assessment of Growth of Infants Fed a Starter Formula With a Whey-Isolate Enriched in Lactoferrin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937014
• Other study ID #: 07.35.INF
• Status: Completed
• Phase: N/A
• First received: July 9, 2009
• Last updated: June 24, 2013
• Start date: February 2010
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical trial is to assess growth (rate of weight gain in grams per day) of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the first four months of life as compared to infants fed a standard infant formula.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 17 Days

Eligibility

Inclusion Criteria:

• Healthy newborn infant

• Full-term (>37 weeks gestation)

• Birth weight between > 2500 and < 4500 g

• Infant's mother has elected not to breastfeed and baby has been exclusively formula fed a minimum 3 days prior to enrollment

• Tolerating a cows milk based formula for at least 3 days

• Study explained and written information provided with Parent/Caregiver demonstrating understanding of the given information

• Informed consent signed (Parent/Legal representative)

• Parent/Caregiver has a working freezer

• Lives within 45 minutes of a study site

Exclusion Criteria:

• Congenital illness or malformation that may affect infant feeding and/or normal growth

• Suspected or known allergy to cow's milk protein

• Significant pre-natal and/or post-natal disease

• Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment

• Infant has received oral or intravenous antibiotic therapy in the 10 days prior to enrollment

• Infant receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements

• Infant currently participating in another clinical study

• Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Infant Nutrition

Intervention

Other:
• standard infant formula
Standard infant formula given during the first 9 months of life, as per standard requirement
• Test formula
Test formula enriched in lactoferrin given during the first 9 months of life, as per standard requirement.

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Pedia Research, LLC	Newburgh	Indiana
United States	Pedia Research, LLC	Owensboro	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean weight gain		4 months	Yes
Secondary	anthropometry, tolerance, morbidity, blood tests		9 months	Yes