Efficacy of a Nutrient Blend in Improving Neurocognitive... | NCT05310396

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Powdered cow's milk-based infant formula containing uniquely processed whey protein	Experimental	Starter and follow up formula containing combination of an HMO blend, myelin nutrient blend, and MOS	Other: Experimental formula
Powdered infant fortified cow's milk	Active Comparator	Standard Starter and follow up formula without added HMOs or MOS containing lower levels of myelin nutrients	Other: Control Formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Experimental formula	Other	Cow's milk-based infant formula with a specific blend of nutrients at pre-defined levels	Powdered cow's milk-based infant formula containing uniquely processed whey protein

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Scores on the Cognitive subscale of the Bayley Scale of Infant Development, 4th Edition	Change in the scores on the Cognitive subscale. The scores range from 40 to 160 and higher scores indicate a better cognitive outcome	12 months

Secondary Outcomes

Measure	Description	Time Frame
Infant Global developmental status in all domains of the Bayley Scale of Infant Development, 4th Edition	Infant Language, motor, socio-emotional, adaptive behaviour, and cognitive scores will be assessed	6 months, 9 months, 12 months, and 24 months
Infant Visual attention

Other Outcomes

Measure	Description	Time Frame
Infant GI Tolerance	Assessed using Infant Gastrointestinal Symptom Questionnaire. The questionnaire comprises of 13 questions assessed on a 5-point Likert Scale with overall scores of 13 (best) to 65 (worst) for overall GI symptoms	1.5-2 months, 6 months, and 12 months
Toddler GI Tolerance

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infants between 45 to 60 days of age at enrolment
Infant's ≥ 37 completed weeks of gestation, with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg and singleton born.
Infants generally healthy at birth with an Apgar score ≥7 at 5 min
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
Signed informed consent obtained for infant's and parents' participation in the study
Parents of infant agree not to enrol infant in another interventional clinical research study while participating in this study
Parent of infant agrees to provide to their infants the study formula and not replace it with another commercial formula.
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.
Parent of infant can be contacted directly by telephone or email throughout the study.

Exclusion Criteria:

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.
Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion)
Infants with known or suspected intolerance to cow milk infant formula or allergy
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
Infants who have been adopted or are foster infants
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
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).