NCT03563391

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Nutricia North America · Industry
• Sex: All
• Age: 1 Month – 8 Months
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2018-01-30
• Primary completion: 2020-04-07
• Completion: 2020-05-30
• First posted: 2018-06-20
• Last updated: 2020-12-08

Locations

5 sites across 1 country: United States