Growth FailureNCT03563391
A Study to Evaluate the Effects of a New Formula on the Growth, Safety and Tolerance of Infants With Growth Failure
A study testing New Infant Formula in people with Growth Failure and Congenital Heart Disease, run by Nutricia North America at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 8 months
- Conditions the study is for
- Growth Failure, Congenital Heart Disease
- What is being tested?
- New Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Jan 2018to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 8 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
GI Care for Kids
Atlanta, Georgia, 30342
East Carolina University
Greenville, North Carolina, 27834
Nemours Children's Specialty Care
Jacksonville, Florida, 32207
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
- Conditions
- Growth Failure, Congenital Heart Disease
- Being tested
- New Infant Formula
- Medical subject headings
- Failure to Thrive, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Infant FormulaOther
New Infant Formula is a specialized, nutritionally complete, nutrient-dense infant formula specifically formulated for infants with growth failure.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of a new infant formula | Experimental | To evaluate the effects of a new formula on the growth, safety and tolerance of infants with growth failure Receives: Other: New Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight-for-age z-score from baseline
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
Measured: 16 weeks
Secondary outcomes (6)
Weight-for-length
z-score
Measured: 16 weeks
Length-for-age
z-score
Measured: 16 weeks
Head circumference-for-age
z-score
Measured: 16 weeks
Mid upper arm circumference (MUAC)-for-age
z-score
Measured: 16 weeks
Weight velocity
z-score
Measured: 16 weeks
Length velocity
z-score
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start30 Jan 2018
- Primary completion7 Apr 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, open-label, multi-site, growth, safety and tolerance study.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia North America
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical College of Wisconsin, GI Care for Kids, East Carolina University, Wake Forest University Health Sciences, Nemours Children's Clinic
- Responsible party
- Sponsor
- Investigators
- Praveen Goday, MD, Principal investigator, The Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563391
- Sponsor's protocol ID
- CT17USCBUFG01
- Status last verified
- Dec 2020
- First submitted
- 28 Mar 2018
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03563391
- Acronym / sponsor ID
- CT17USCBUFG01
- Conditions
- Growth Failure, Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nutricia North AmericaIndustry (pharma, biotech, devices)
- Collaborators
- Medical College of Wisconsin, GI Care for Kids, East Carolina University, Wake Forest University Health Sciences, Nemours Children's Clinic
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 7 Apr 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 20 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, open-label, multi-site, growth, safety and tolerance study.
| Arm | Type | Receives |
|---|---|---|
| Evaluation of a new infant formula | Experimental | Other: New Infant FormulaTo evaluate the effects of a new formula on the growth, safety and tolerance of infants with growth failure |
Who may qualify
- Ages
- 1 month to 8 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New Infant FormulaNew Infant Formula is a specialized, nutritionally complete, nutrient-dense infant formula specifically formulated for infants with growth failure. | Other | Evaluation of a new infant formula |
Primary outcome
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
6 secondary outcomes
Weight-for-length
Time frame: 16 weeks
Length-for-age
Time frame: 16 weeks
Head circumference-for-age
Time frame: 16 weeks
Mid upper arm circumference (MUAC)-for-age
Time frame: 16 weeks
Weight velocity
Time frame: 16 weeks
Length velocity
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Praveen Goday, MD principal investigator
The Medical College of Wisconsin
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Infant Formula in people with Growth Failure and Congenital Heart Disease, run by Nutricia North America at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight-for-age z-score from baseline (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.