Clinical trial NCT05310396: Efficacy of a Nutrient Blend in Improving Neurocognitive and Behavioral Outcomes in Infants: a Randomized, Controlled, Intervention Study
Official title: Efficacy of a Nutrient Blend Comprised of Specific Nutrients in Improving Neurocognitive and Behavioural Outcomes in Infants: a Randomized, Controlled, Intervention Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infant Nutrition
Cognitive Development
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2022-04-04
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to demonstrate the efficacy of the nutrient blend in a starter infant formula (IF) and follow up infant formula (FUF) in improving the neurocognitive and behavioural outcomes among formula-fed infants randomized to the experimental formula (EF) versus the control formula (CF).

Detailed description: This is a prospective, randomized, controlled, double-blind, 2-arm parallel-group clinical trial in the Philippines. Subjects will be recruited from a single centre; in case of insufficient recruitment, more sites will be added to the study. The clinical trial is composed of two parts: a double-blind interventional period and a follow-up period. The first period is the double-blind intervention phase from enrolment (V1) until age 12 months (V5). The intervention will be provided only during this double-blind phase. The second period is a non-interventional follow-up period from age 12 months until age 24 months.

Eligibility criteria: Inclusion Criteria:

1. Infants between 45 to 60 days of age at enrolment
2. Infant's ≥ 37 completed weeks of gestation, with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg and singleton born.
3. Infants generally healthy at birth with an Apgar score ≥7 at 5 min
4. Exclusively formula fed for at least 14 days before randomization and the choice of formula feeding has been taken by the parents before the beginning of the trial
5. Signed informed consent obtained for infant's and parents' participation in the study
6. Parents of infant agree not to enrol infant in another interventional clinical research study while participating in this study
7. Parent of infant agrees to provide to their infants the study formula and not replace it with another commercial formula.
8. Parent of the infant is of legal age of consent, must understand the informed consent form and other study documents, willing and able to fulfil the requirements of the study protocol.
9. Parent of infant can be contacted directly by telephone or email throughout the study.

Exclusion Criteria:

1. History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant.
2. Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion)
3. Infants with known or suspected intolerance to cow milk infant formula or allergy
4. The infant is identified to have a chromosomal or major congenital anomaly or significant medical and/or genetic conditions that interferes with adequate functioning in daily life or likely to interfere with normal growth and development or with the normal maturation of visual or cognitive function (including visual/hearing impairment), known head or brain disease, injury such as microcephaly or macrocephaly, immunocompromised or suffered from significant illness, developmental delay or disability
5. Infants who have been adopted or are foster infants
6. Infants born to mothers with chronic illness, such as HIV disease, renal or hepatic disease, type 1 or type 2 diabetes, alcoholism, or substance abuse
7. Presence of a first degree relative with neurologic or psychiatric diseases (e.g., attention deficit hyperactivity disorder, autism, behavioural problems, bipolar disorder, depression, intellectual disability, or schizophrenia).

Primary outcomes:
measure: Scores on the Cognitive subscale of the Bayley Scale of Infant Development, 4th Edition
timeFrame: 12 months
Secondary outcomes:
measure: Infant Global developmental status in all domains of the Bayley Scale of Infant Development, 4th Edition
timeFrame: 6 months, 9 months, 12 months, and 24 months
measure: Infant Visual attention
timeFrame: 4 months, 6 months, 9 months, and 12 months
measure: Infant Visual learning
timeFrame: 4 months, 6 months, 9 months, and 12 months
measure: Early language development
timeFrame: Words and Gestures (long form) at 12 months and Words and Sentences (long form) at 24 months
measure: Working memory and inhibitory control
timeFrame: 24 months
measure: Behavioral manifestations of executive function
timeFrame: 24 months
measure: Infant temperament
timeFrame: 1.5-2 months, 6 months, and 12 months
measure: Child temperament
timeFrame: 24 months
measure: Infant sleep
timeFrame: 1.5-2 months, 6 months, 12 months, and 24 months
measure: Infant fecal microbiota
timeFrame: 1.5-2 months (but before starting study formula), and just prior to 6 months, and 12 months
measure: Infant immune and gut health biomarkers
timeFrame: 1.5-2 months (but before starting study formula), 6 months, and 12 months
Other outcomes:
measure: Infant GI Tolerance
timeFrame: 1.5-2 months, 6 months, and 12 months
measure: Toddler GI Tolerance
timeFrame: 24 months
measure: Head circumference
timeFrame: 1.5-2 months, 4 months, 6 months, 9 months, 12 months and 24 months
measure: Weight
timeFrame: 1.5-2 months, 4 months, 6 months, 9 months, 12 months and 24 months
measure: Length/Height
timeFrame: 1.5-2 months, 4 months, 6 months, 9 months, 12 months and 24 months
measure: BMI
timeFrame: 1.5-2 months, 4 months, 6 months, 9 months, 12 months and 24 months
measure: Z-scores
timeFrame: 1.5-2 months, 4 months, 6 months, 9 months, 12 months and 24 months
measure: Incidence of infant illness and infection
timeFrame: 1.5-2 months, 13 months, and additionally at 23.8 months and 24 months
measure: Formula intake adherence
timeFrame: Completed by the parent on a weekly basis beginning on the first day of intervention (1 day after V1 after the stool collection)
measure: Infant dietary intake
timeFrame: Completed at home just prior to clinic visits at 6 months, 12 months and 24 months
measure: Maternal Postpartum depression/ anxiety
timeFrame: 1.5-2 months and 4 months
measure: Parenting Stress
timeFrame: 1.5-2 months, 6 months, 12 months and 24 months
Locations:
city: Las Piñas
country: Philippines
facility: Las Piñas Doctors Hospital
Study officials:
affiliation: Las Pinas Doctors Hospital
name: Elvira M Estorninos, MD
role: PRINCIPAL_INVESTIGATOR
References: