Clinical Trials Logo
  1. Home
  2. Infant, Newborn
  3. NCT00705562
  4. Details
NCT00705562 Clinical Trial

Tolerance of Healthy Term Infants Fed Infant Formulas

Infant, Newborn Clinical Trial

Official title:
Tolerance of Healthy Term Infants Fed Infant Formulas

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00705562
Other study ID # AK62
Secondary ID
Status Completed
Phase Phase 2
First received June 24, 2008
Last updated January 2, 2009
Start date June 2008
Est. completion date December 2008

Study information
Verified date January 2009
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.

Recruitment information / eligibility
Status Completed
Enrollment 190
Est. completion date December 2008
Est. primary completion date October 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 8 Days
Eligibility Inclusion Criteria:

- Healthy, term infants; singleton birth; 37-42 weeks of age; >2490gms at birth; 0-8 days of age

Exclusion Criteria:

- medications/foods/formulas affecting GI tolerance;adverse medical history with possible effect on tolerance or growth

Study Design

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

Related Conditions & MeSH terms

Intervention

Other:
• milk protein formulas, varying carbohydrate/protein sources
ad lib for 0-8 days of age until 28 days of age

Locations
Country Name City State
United States Global Clinical Investigation Aventura Florida
United States University of Maryland Baltimore Maryland
United States Kentucky Pediatric Research Bardstown Kentucky
United States MetroHealth Medical Center Cleveland Ohio
United States University of Iowa Coralville Iowa
United States Medical Associates Clinic Dubuque Iowa
United States Pediatric Associates of Fairfield Fairfield Ohio
United States Ohio Pediatric Research Association Huber Heights Ohio
United States Midwest Children's Health Research Institute, LLC Lincoln Nebraska
United States Institute of Clinical Research Mayfield Heights Ohio
United States West Virginia University Morgantown West Virginia
United States The Center for Human Nutrition Omaha Nebraska
United States PediaResearch, Inc Owensboro Kentucky
United States Primary Physicians Research, Inc Pittsburgh Pennsylvania
United States University of South Florida Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gastrointestinal tolerance 0-8 days of age until 28 days of age No
Secondary GI and intake parameters 0-8 to 28 days of age No
See also
  Status Clinical Trial Phase
Completed NCT04994652 - Video- Or Direct Laryngoscopy for Endotracheal Intubation in Newborns N/A
Completed NCT02064712 - Determining an Optimal Weaning Method of Nasal Continuous Positive Airway Pressure in Preterm Neonates N/A
Withdrawn NCT01335919 - Neonatal Non-Invasive Hemoglobin Determination N/A
Terminated NCT01192776 - Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE) N/A
Completed NCT00114543 - Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight Phase 3
Completed NCT00011362 - Dexamethasone Therapy in VLBW Infants at Risk of CLD Phase 3
Recruiting NCT05001334 - Effect of Kangaroo Care on Phyiological Weight Loss in Term Newborns N/A
Completed NCT01193270 - Vitamin E for Extremely Preterm Infants Phase 1
Completed NCT00005772 - Whole-Body Cooling for Birth Asphyxia in Term Infants Phase 3
Terminated NCT00005776 - Inhaled Nitric Oxide Study for Respiratory Failure in Newborns Phase 3
Completed NCT01203423 - Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study
Completed NCT06120062 - Effect of Swaddling and Inhaling Breast Milk Odour on the Pain and Comfort
Completed NCT00820677 - Newborn Health Information Study N/A
Active, not recruiting NCT00189384 - Efficacy Study of Community-Based Treatment of Serious Bacterial Infections in Young Infants Phase 3
Completed NCT01203410 - Prediction of Jaundice in Term Infants
Recruiting NCT03745963 - The Influence of Skin-to-skin Contact on Cortical Activity During Painful Procedures on Preterm Infants in the NICU Phase 3
Completed NCT04050384 - Effect of a Vibratory Stimulus on Mitigating Nociception-specific Responses to Skin Puncture in Neonates N/A
Completed NCT01793129 - Preemie Hypothermia for Neonatal Encephalopathy N/A
Withdrawn NCT00598429 - Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure Phase 2
Completed NCT01223287 - Physiologic Definition of Bronchopulmonary Dysplasia N/A