Adverse Event, Growth, Tolerance
Conditions
Brief summary
Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT). Two published RCTs have demonstrated that infant formulas supplemented with 2'FL or 2'FL+LNnT are safe, well-tolerated, support normal grow, and may support healthy GI function and confer immune benefits. The performance of HMOs-supplemented formulas assessed in a real-world setting is complementary to previously conducted RCTs conducted in highly controlled clinical settings. Main objectives will be to document the growth and feeding tolerance of healthy term infants consuming an infant formula supplemented with HMOs in a real-world setting. In addition to it considering the potential health/immune benefits of HMOs, it is also important explore the incidences of illnesses (i.e., respiratory illnesses, GI illnesses, and fever) associated with consuming HMOs-supplemented formulas.
Detailed description
Objectives: The main objective of this study is to document the growth and feeding tolerance of healthy term infants consuming an infant formula supplemented with HMOs for 8 weeks (56 days), in a real-world setting. Main endpoints: 1. Growth documented via monitoring the anthropometric parameters including weight, length, head circumference, BMI and their corresponding z-scores (i.e., z-scores for weight-for-age, length-for-age, weight-for-length, head circumference-for-age, and BMI-for-age) calculated using the 2006 WHO Growth Standards 2. Feeding tolerance assessed via monitoring parent-reported overall GI symptom burden measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score (13-item summary score) Additional objectives: To describe the following outcomes in infants fed an infant formula supplemented with HMOs: 1. Formula acceptability 2. Despite there are no expected safety concerns, standard Adverse Events (AEs) monitoring will be implemented during the study Additional endpoints: 1. Formula acceptability assessed by the Study Formula Satisfaction Questionnaire 2. Reported AEs and Serious Adverse Events (SAEs) including type, incidence, severity, seriousness and relation to study formula consumption as well as concomitant medications and non-pharmacological treatments. * Select morbidities of interest (i.e., respiratory illnesses, GI illnesses, and fever) will be collected as part of AE reporting and specific corresponding AE guidance forms will be used to standardize reporting of such AEs Trial design: Uncontrolled, single arm, open-label, prospective study in infants (enrolled at postnatal age 7 days to 2 months) fed the study formula for 8 weeks (56 days) Trial population: Healthy, male and female, term infants, 7 days postnatal age to 2 months of age at the enrollment Treatment duration: Total study participation/intervention up to approximately 8 weeks
Interventions
OTHERHMO Supplemented Infant Formula
Starter Infant formula supplemented with 0.18 g /100g powder of 2'FL HMOs,1.2 g protein/100 ml (70% whey) and. B. Lactis.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Days to 2 Months
Healthy volunteers
Yes
Inclusion criteria
1. Evidence of personally signed and dated informed consent document indicating that the infant's parent(s) has been informed of all pertinent aspects of the study 2. Parent(s) Are willing and able to fulfill the requirements of the study protocol 3. Healthy full term (37-42 weeks gestation) infant 4. Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months 5. Parent(s) must have independently elected, before enrollment, to formula feed. IF or mixed feeding. Prior to enrollment parents were counselled about the superiority and advantages of exclusive breastfeeding.
Exclusion criteria
1. Had any known case of intolerance/allergy to cow's milk (for formula-fed group only) 2. Had conditions requiring infant feedings other than those specified in the protocol 3. Evidence of significant cardiac, respiratory, endocrinologist, hematologic, gastrointestinal, or other systemic diseases/disorders 4. Parent(s) refusal to participate in the study 5. Infant had consumed any other infant formula in 3 days prior to study start
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization (WHO) based weight-for-age z-scores Weight-for-age z-scores using WHO growth standards [Time Frame: 8 weeks (study end)] | 8 Weeks (Study End) | Weight-for-age z-scores using WHO growth standards |
| World Health Organization (WHO) based length-for-age z-scores | 8 Weeks (Study End) | Length-for-age z-scores using WHO growth standards |
| World Health Organization (WHO) based weight-for-age z-scores | 8 Weeks (Study End) | Weight-for-length z-scores using WHO growth standards |
| Feeding Tolerance | 4 Weeks (Midpoint) and 8 Weeks (Study End Point) | The Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score will be used to assess GI distress. This is a validated 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress. A composite IGSQ score is derived from summing the individual scores with a possible range of 13 to 65 where higher values indicate greater GI distress and values ≤23 indicate no digestive distress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Formula acceptability | 4 Weeks (study midpoint) and 8 weeks (study end point) | Study Formula Satisfaction Questionnaire |
| Standard adverse events (AEs) reporting for safety assessment | Time Frame: From the time the informed consent form has been signed at enrollment infant age less than 7 days to 2 months through the 8 weeks of interventio | Reported adverse events (AEs) and Serious Adverse Events (SAEs) include type, incidence, severity, seriousness and relation to feeding |
Countries
Pakistan
Outcome results
None listed