A Study to Evaluate the Effects of a New Formula on the Growth, Safety and Tolerance of Infants With Growth Failure

NCT03563391 | Completed DMC

• 1 other identifier: CT17USCBUFG01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  16 weeks

Secondary Outcomes (6)

• Weight-for-length

  16 weeks

• Length-for-age

  16 weeks

• Head circumference-for-age

  16 weeks

• Mid upper arm circumference (MUAC)-for-age

  16 weeks

• Weight velocity

  16 weeks

Other Outcomes (2)

• Gastrointestinal tolerance

  16 weeks

• Number of adverse events related to new infant formula (New Formula)

  Up to 21 weeks starting from date of baseline visit

Study Arms (1)

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

Other: New Infant Formula

Interventions

New Infant Formula OTHER

New Infant Formula is a specialized, nutritionally complete, nutrient-dense infant formula specifically formulated for infants with growth failure.

Evaluation of a new infant formula

Eligibility Criteria

• Age: 1 Month - 8 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)
• \. 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.

Sponsors & Collaborators

• Nutricia North America: lead
• Medical College of Wisconsin: collaborator
• GI Care for Kids: collaborator
• East Carolina University: collaborator
• Wake Forest University Health Sciences: collaborator
• Nemours Children's Clinic: collaborator

Study Sites (5)

Nemours Children's Specialty Care

Jacksonville, Florida, 32207, United States

Location

GI Care for Kids

Atlanta, Georgia, 30342, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Failure to Thrive; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Praveen Goday, MD

  The Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, open-label, multi-site, growth, safety and tolerance study.

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: June 20, 2018
• Study Start: January 30, 2018
• Primary Completion: April 7, 2020
• Study Completion: May 30, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-12

Locations

US (5)