Growth of Infants Fed an Extensively Hydrolyzed Infant Formula

Growth Clinical Trial

Official title:

Assessment of Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210391
• Other study ID #: 09.43.PED
• Status: Completed
• Phase: N/A
• First received: September 27, 2010
• Last updated: June 25, 2014
• Start date: November 2010
• Est. completion date: July 2013

Study information

• Verified date: June 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new extensively hydrolyzed formula (EHF) to infants consuming a commercially available EHF.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 4 Months

Eligibility

Inclusion Criteria:

• Healthy newborn singleton infant

• Full-term (>= 37 weeks gestation)

• Birth weight between >= 2500 and < =4500 g

• 14 ± 3 days of age on enrollment

• Infant's mother has elected not to breastfeed

• baby has been exclusively formula fed a minimum of 3 days prior to enrollment

• Study explained and written information provided with Parent/Caregiver

• Informed consent signed (parent/legal representative)

Exclusion Criteria:

• Congenital illness or malformation affecting infant feeding and/or 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 IV antibiotic therapy in the 10 days prior to enrollment

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

• Infant has received probiotics in the seven days prior to enrollment

• 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, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Growth

Intervention

Other:
• Extensively hydrolyzed whey infant formula
New hydrolyzed infant formula.
• Extensively hydrolyzed casein infant formula
Commercially available infant formula.

Locations

Country	Name	City	State
United States	Scott & White Wells Branch Clinic	Austin	Texas
United States	ARK-LA-Tex Pediatric Research	Bossier City	Louisiana
United States	Alpha Clinical Research	Clarksville	Tennessee
United States	Colorado Springs Health Partners	Colorado Springs	Colorado
United States	Square-1 Clinical Research	Erie	Pennsylvania
United States	Cyn3rgy Research	Gresham	Oregon
United States	Jackson Clinic	Jackson	Tennessee
United States	Scott & White Killeen Clinic	Killeen	Texas
United States	Clinical Research of Nevada	Las Vegas	Nevada
United States	Tanner Clinic	Layton	Utah
United States	DCOL Center for Research	Longview	Texas
United States	Institute of Clinical Research	Mayfield Heights	Ohio
United States	The Clinical Trials Center	New Orleans	Louisiana
United States	Pedia Research	Newburgh	Indiana
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Pedia Research	Owensboro	Kentucky
United States	Clinical Research Partners	Richmond	Virginia
United States	Southwest Children's Research Associates	San Antonio	Texas
United States	Scott & White Temple	Temple	Texas
United States	Wenatchee Valley Medical Center	Wenatchee	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Gain	Mean weight gain (g/day) from enrollment to 4 months of age.	4 Months	No