None listed
Conditions
Interventions
Intervention1: Formula - Fed Group: Nutrient-enriched formula & Standard formula.
Frequency: Feeding of study formulas begins immediately after enrollment and continues until 6 months of age. Standard
Sponsors
Esther Lok
Eligibility
Inclusion criteria
Inclusion criteria: 1. Having obtained his/her parentsâ?? (or his/her legally accepted representativeâ??s [LARâ??s]) written informed consent and having evidence of a personally signed and dated informed consent document indicating that the infantâ??s parents/LAR have been informed of all pertinent aspects of the study 2. For infants in the formula-fed groups only: infants who require formula feeding due to lactation failure after minimum 2 rounds of breastfeeding counseling (sites may conduct additional rounds of counseling depending on local practice; lactation failure is defined by unsatisfactory infant weight gain [less than 30g/d] and infant voiding urine less than 6 times during day time) 3. Birth weight 4. Full-term birth (gestational age >= 37 weeks and 5. Age 6. For infants in the HM-fed AGA comparator group only: born to mothers with pre-pregnancy body mass index (BMI) >= 18.5 and < 25 kg/m2
Exclusion criteria
Exclusion criteria: 1. Mothers with Type-1 diabetes 2. Mothers who smoked > 10 cigarettes per day during pregnancy 3. Mothers who used illicit drugs or alcohol ( > 3 alcoholic beverages per week) during pregnancy. 4. Suspected or documented systemic or congenital infections. 5. Genetic or any other type of congenital malformations, metabolic, cardiovascular, gastrointestinal, pancreatic, or hepatic diseases or medical conditions that could compromise growth and/or food intake 6. Fit to be discharged from neonatal intensive care unit (NICU) in > 5 consecutive days, with the exception of infants in the NICU due to jaundice only 7. Known or suspected intolerance / allergy to milk protein or any ingredient in the study formulas 8. For infants in the HM-fed groups only: infants who are consuming fortified human milk or formula 9. Participation in any other interventional clinical trial during the 14 days prior to enrollment 10. Infants or infantâ??s family who in the Investigatorâ??s judgment cannot be expected to comply with the protocol or study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cognitive domain of the Bayley Scales of Infant and Toddler Development evaluated at 2 years of age. 2. Length-for-age Z-score evaluated at 2 years of age using the WHO growth chart. 3. Systolic blood pressure, evaluated at 2 years of age.Timepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Metabolic endpoints: HOMA-IR evaluated at 2 &5 yrs Body fat mass (%) assessed by deuterium dilution & fat distribution Panel of metabolic & cardiovascular biomarkers in blood, urine, BP Cognitive endpoints: Total Bayley-III score evaluated at 2 yrs WPPSI-IV evaluated at 5 yrs Anthropometry endpoints: Anthropometry Relationships between growth trajectory patterns & metabolic, cardiovascular, neurodevelopmental, epigenetic biomarkersTimepoint: 2 years & 5 years | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
Kids Clinic Private Limited (Cloud Nine)
Outcome results
None listed