DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas

Information source: Mead Johnson Nutrition
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cow's Milk Allergy; Intolerance to Extensively Hydrolyzed Formulas; Intolerance to Breast Milk

Intervention: Amino Acid-based Formula with high DHA and ARA (Other); Amino Acid-based Formula with lower DHA and ARA (Other)

Phase: N/A

Status: Withdrawn

Sponsored by: Mead Johnson Nutrition

Official(s) and/or principal investigator(s):
Nikhil Thapar, M.D., Principal Investigator, Affiliation: UCL Institute of Child Health and Great Ormond Street Hospital

Summary

This clinical trial will compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months.

Clinical Details

Official title: Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based Formulas

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Primary outcome: Level of fatty acids in whole blood of infants

Secondary outcome:

body weight

Occurrence of allergic manifestations

Occurrence of adverse events

Incidence of gas

Incidence of fussiness

Stool characteristics

Body length

Head Circumference

Eligibility

Minimum age: N/A. Maximum age: 6 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 0 to 6 months of age inclusive

- Born at ≥ 37 weeks gestation

- Birth weight of 2500 g (5 lb 8 oz) or more

- Infants suspected to be cow's milk allergic and who do not tolerate extensively

hydrolyzed formula OR infants intolerant to breast milk

- Infants with symptoms suggestive of cow's milk allergy

- Signed Informed Consent

Exclusion Criteria:

- Infants who for whatever reasons were not discharged home as per routine

- Infants with metabolic illness requiring a special formula

- Infants fed with nasogastric tube

Locations and Contacts

Great Ormand Street Hospital and Institute of Child Health, London, United Kingdon WC1N1EH, United Kingdom
Additional Information

Starting date: January 2012
Last updated: March 20, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017