Infant Growth Clinical Trial
— ComplementOfficial title:
Observational Study of Infants Fed With Dairy and Plant Based Infant Formula
NCT number | NCT05804214 |
Other study ID # | SBB22R&41357 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | April 11, 2023 |
Est. completion date | July 14, 2023 |
Verified date | August 2023 |
Source | Nutricia Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A study to assess and evaluate adequate growth in infants receiving a dairy and plant based infant formula in a real-world setting, and parents' and infants' experiences with this infant formula.
Status | Terminated |
Enrollment | 2 |
Est. completion date | July 14, 2023 |
Est. primary completion date | July 14, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 7 Months |
Eligibility | Inclusion Criteria: 1. Parents autonomously decided to feed their infant with at least one bottle per day of dairy and plant based infant formula in combination with breastfeeding or as sole source of feeding. 2. Parents' intention to feed their infant with dairy and plant based infant formula for at least 2 months as of start with product 3. Infant started feeding with dairy and plant based infant formula = 4 months of age 4. Infant is being fed daily with dairy and plant based infant formula at time of enrolment Exclusion Criteria: 1. Infant started feeding with dairy and plant based infant formula >3 months ago at time of enrolment 2. Participation of the infant in any other studies involving infant formula feeding (products) concomitantly |
Country | Name | City | State |
---|---|---|---|
Netherlands | Ncru, Danone Nutricia Research | Utrecht |
Lead Sponsor | Collaborator |
---|---|
Nutricia Research |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Development of weight, length, and head circumference | Agreed clinical experts' judgement about development of weight, length and head circumference (adequate/inadequate) as measured at the Municipal Child Healthcare Clinic visits and transcribed by the parents in a digital tool | 5 Months +2 weeks | |
Secondary | Development of length, BMI, and head circumference | Agreed clinical experts' judgement about adequate development of length, BMI (derived from weight and length outcomes), and head circumference (adequate/inadequate) | 5 Months + 2 weeks | |
Secondary | Weight-for-age, length-for-age, BMI-for-age, and head circumference-for-age | Weight-for-age, length-for-age, BMI-for-age, and head circumference-for-age since start of the dairy and plant based infant formula (according to the country specific z-score by age and sex) | 5 Months + 2 weeks | |
Secondary | Experience of parent and infant | Parent's and infant's experiences with the dairy and plant based infant formula after using the product for 2 and 5 months and assessed via a digital questionnaire | after using product for 2 and 5 Months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06091917 -
Modulating Early-life Nutrition for Childhood Obesity Prevention
|
N/A | |
Completed |
NCT02111837 -
Effects of Specific Lipid Fractions-enriched Infant Formulae
|
N/A | |
Recruiting |
NCT05119166 -
International Milk Composition (IMiC) Consortium
|
||
Completed |
NCT02142647 -
Effect of Protein From Complementary Foods on Infant Growth, Body Composition and Gut Health
|
N/A | |
Completed |
NCT00388141 -
Nursing and Nurturing Premature Infants
|
Phase 0 | |
Recruiting |
NCT04306263 -
Effect of a New Infant Formula With Specific Ingredients
|
N/A | |
Completed |
NCT01084109 -
First Bites: Complementary Feeding - A Global Network Cluster Randomized Controlled Trial
|
Phase 3 | |
Completed |
NCT02307760 -
Evaluation of Human Milk Fortifiers in Preterm Infants
|
N/A | |
Recruiting |
NCT03808207 -
Human Milk Lipid Profile Assessment and Influences of Mother's Diet
|
N/A | |
Completed |
NCT03993860 -
Introduction of Fish Early in the Complementary Feeding Period to Improve Infant Growth
|
N/A |