Assessment of Growth of Infants Fed a New Formula

• Sponsor: Nestlé (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00937014
• Collaborator: (none)
• Enrollment: 180
• Locations: 3
• Arms: 2
• Duration (Months): 40
• Patients Per Site: 60
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infant Nutrition	Other: standard infant formula; Other: Test formula	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Official Title: Assessment of Growth of Infants Fed a Starter Formula With a Whey-Isolate Enriched in Lactoferrin
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard infant formula	Other: standard infant formula; Standard infant formula given during the first 9 months of life, as per standard requirement
Experimental: Test formula	Other: Test formula; Test formula enriched in lactoferrin given during the first 9 months of life, as per standard requirement.

Outcome Measures

Primary Outcome Measures

1. Mean weight gain [4 months]

Secondary Outcome Measures

1. anthropometry, tolerance, morbidity, blood tests [9 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 11 Days to 17 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pedia Research, LLC	Newburgh	Indiana	United States	47630
2	Pedia Research, LLC	Owensboro	Kentucky	United States	42301
3	University of Maryland School of Medicine	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• Nestlé

Investigators

• Principal Investigator: Susan Feigelman, MD, University of Maryland School of Medicine, Department of Pediatrics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nestlé
• ClinicalTrials.gov Identifier: NCT00937014
• Other Study ID Numbers: 07.35.INF
• First Posted: Jul 10, 2009
• Last Update Posted: Jun 26, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Nestlé: infant formula; growth; weight

Study Results

No Results Posted as of Jun 26, 2013