- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03563391
A Study to Evaluate the Effects of a New Formula on the Growth, Safety and Tolerance of Infants With Growth Failure
December 7, 2020 updated by: Nutricia North America
A Prospective, Open Label, Multi-site Study in North America to Evaluate the Effects of a New Ready-to-feed, Nutrient Dense Formula on the Growth, Safety and Tolerance of Infants With Growth Failure
This study is a prospective, open-label, multi-site, growth, safety and tolerance study to evaluate a NF (New Formula).
A minimum of 45 evaluable infants with confirmed growth failure will be enrolled.
Growth failure for 30 infants will be due to congenital heart disease and 15 infants due to other organic or non-organic causes.
Study infants (in-patient or living with parents/ caregivers at home) will be fed the NF for a period of up through 16 weeks or until the time the infant subject meets criteria for switching to a lower calorie density formula, relative to baseline in infants with growth failure.
Weight, height, head circumference and mid upper arm circumference will be measured regularly throughout the study.
NF and other food intake, tolerance and stool diaries will be completed regularly.
Serious adverse and adverse events will be monitored throughout the study.
Infants will be evaluated, at each study visit, for criteria to switch to a lower calorie density formula.
The primary objective is to improve weight-for-age z score relative to baseline.
The secondary objectives are to improve weight-for-length, length-for-age, head circumference-for-age, mid upper arm circumference-for-age, weight velocity and length velocity z scores relative to baseline.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32207
- Nemours Children's Specialty Care
-
-
Georgia
-
Atlanta, Georgia, United States, 30342
- GI Care for Kids
-
-
North Carolina
-
Greenville, North Carolina, United States, 27834
- East Carolina University
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Baptist Medical Center
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- The Medical College of Wisconsin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 8 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Infants must have attained term gestation (≥37 weeks of gestational age) at the time of screening
- Infants, male or female, aged 1 through 8 months
- Infants with congenital heart disease or other organic/non-organic cause of growth failure with a weight-for-length z score ≤ -1.0 or weight gain ≤ -2.0 z score based on WHO growth standards. (for weight gain metrics please see Appendix I): Weight gain (g) for boys and girls by age ( -2 z scores for weight velocity). Infants with Down syndrome must have a weight for length z-score ≤-1.0 z score. Infants with Down syndrome who meet the weight gain criterion (≤ -2.0 z-score weight gain) and have a weight for length z-score >-1.0 z-score will not be eligible for enrolment.
- Infants expected to consume (or obtain via tube feeding), on average, 80% of their total energy intake from NF for 16 weeks
- Infants from families who are willing and able to have anthropometrics taken at the required frequency as well as to comply with all other protocol requirements
- Written informed consent from the parent/caregiver or legal guardian
- Parent/caregiver or legal guardian must be able to read, write, and understand English
Exclusion Criteria:
- Infants with known or suspected complex gastrointestinal anomalies or dysfunction, hepatic* or renal* dysfunction, or inherited metabolic disorders, congenital neurological insults, suspected or diagnosed conditions associated with malabsorption (e.g. cystic fibrosis)
- Infants with known or suspected systemic or congenital infections (e.g. human immunodeficiency virus, HBV, HCV)
- 3. Infants with known or suspected genetic conditions listed in Appendix VI and/or metabolic conditions known to interfere with growth or body dysmorphology that can interfere with obtaining standard anthropometric measurements (weight, length, head circumference, and mid upper arm circumference), with the exception of infants diagnosed with Down syndrome who may be enrolled in the study
- Infants with known or suspected cow milk allergy or children who have received cow milk formula for 7 days or less
- Infants expected to consume on average more than 20% of their energy intake from non-NF sources of nutrition: solids, expressed breast milk and /or parenteral nutrition.
- Child feeding directly at the breast more than twice per day
- Infants participating in any other studies involving investigational or marketed products concomitantly or within two weeks prior to the entry into the study. Infants participating in vaccination trials, who are only receiving follow-up blood monitoring, are not excluded.
- Principal Investigator's uncertainty about the willingness or ability of the parent/caregiver or legal guardian to comply with the protocol requirements
- Infants whose parent is younger than the legal age of consent
- Infants born large for gestational age (LGA). LGA: Birth weight > 90th percentile for gestational age (please see chart in Appendix I)
- Infants born small for gestational age (SGA). SGA: Birth weight < 10th percentile for gestational age (please see chart in Appendix I) * Note: For hepatic dysfunction, a conjugated bilirubin >2.0 mg/dL and for renal dysfunction child should not meet any of the pRIFLE criteria for renal disease (estimated creatinine clearance decreased by 25% by the Schwartz formula or urine output <0.5 mL/kg per hour over the previous 8 or more hours) or has chronic medical renal disease. In most children labs need not be obtained. These criteria only come into play when there is a consideration of liver or renal disease in the individual child.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Evaluation of a new infant formula
To evaluate the effects of a new formula on the growth, safety and tolerance of infants with growth failure
|
New Infant Formula is a specialized, nutritionally complete, nutrient-dense infant formula specifically formulated for infants with growth failure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in weight-for-age z-score from baseline
Time Frame: 16 weeks
|
weight for age z-score at 16 weeks (or at time of meeting criteria to switch to lower density formula if criteria is met prior to 16 weeks) and z-score at baseline
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight-for-length
Time Frame: 16 weeks
|
z-score
|
16 weeks
|
Length-for-age
Time Frame: 16 weeks
|
z-score
|
16 weeks
|
Head circumference-for-age
Time Frame: 16 weeks
|
z-score
|
16 weeks
|
Mid upper arm circumference (MUAC)-for-age
Time Frame: 16 weeks
|
z-score
|
16 weeks
|
Weight velocity
Time Frame: 16 weeks
|
z-score
|
16 weeks
|
Length velocity
Time Frame: 16 weeks
|
z-score
|
16 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastrointestinal tolerance
Time Frame: 16 weeks
|
3-day diaries
|
16 weeks
|
Number of adverse events related to new infant formula (New Formula)
Time Frame: Up to 21 weeks starting from date of baseline visit
|
Number of adverse events evaluated to be related to new infant formula (New Formula) using Adverse Events Decision Tree criteria
|
Up to 21 weeks starting from date of baseline visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Praveen Goday, MD, The Medical College of Wisconsin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2018
Primary Completion (Actual)
April 7, 2020
Study Completion (Actual)
May 30, 2020
Study Registration Dates
First Submitted
March 28, 2018
First Submitted That Met QC Criteria
June 19, 2018
First Posted (Actual)
June 20, 2018
Study Record Updates
Last Update Posted (Actual)
December 8, 2020
Last Update Submitted That Met QC Criteria
December 7, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT17USCBUFG01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Congenital Heart Disease
-
University of UlsterBelfast Health and Social Care TrustCompletedCongenital Heart Disease | Congenital Heart Defect | Adult Congenital Heart DiseaseUnited Kingdom
-
Children's Hospital Medical Center, CincinnatiNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Disease CongenitalUnited States
-
Vanderbilt University Medical CenterEnrolling by invitationCongenital Heart Disease | Congenital Heart Defect | Congenital Heart MalformationsUnited States
-
YHAlattarNot yet recruitingCritical Congenital Heart Disease
-
University Hospital TuebingenCompletedComplex Congenital Heart DiseaseGermany
-
The Hospital for Sick ChildrenCompletedCongenital Heart Disease (CHD)Canada
-
University College, LondonSociety for Cardiothoracic Surgery in Great Britain & Ireland; British Congenital...Unknown
-
University of California, DavisCompletedCyanotic Congenital Heart DiseaseUnited States
-
Assistance Publique Hopitaux De MarseilleRecruitingComplex Congenital Heart DiseaseFrance
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI); Boston Children's HospitalEnrolling by invitation
Clinical Trials on New Infant Formula
-
Jovie USA, LLCIQVIA RDS Inc.; ObvioHealthCompleted
-
Laboratorios OrdesaUnknownInfant DevelopmentSpain
-
Bobbie Baby, IncRecruitingHealthy GrowthUnited States
-
Danone NutriciaNutricia Early Life Nutrition (Shanghai) Co., LtdCompletedHealthy InfantsChina
-
Junlebao Dairy Group Co., Ltd.Merieux NutriSciences (China)Recruiting
-
United PharmaceuticalsDelta ConsultantsRecruitingFunctional ConstipationItaly
-
Abbott NutritionCompleted
-
Abbott NutritionCompleted
-
Société des Produits Nestlé (SPN)University College, LondonCompletedGrowth | Infant FormulaUnited Kingdom