None listed
Conditions
Interventions
None listed
Sponsors
Abbott Nutrition Research and Development ANRD India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Mother is at 33-42 weeks of pregnancy, is between 20 and 35 years of age and is contactable by telephone 2. Mother is non-smoker and non-alcoholic. 3. Mother has BMI 4. Mother confirms her intention to breast feed for 4 months. 5. Infant is a singleton with a gestational age of >37-42 weeks and is able to feed from the mother normally. 6. Infants born between 33 to 7. Infant is judged to be in good health in the opinion of the investigator. 8. Mother or Legally Acceptable Representative (LAR) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) or other applicable privacy regulation authorization prior to any participation in the study.
Exclusion criteria
Exclusion criteria: 1. An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential effects on infantâ??s growth and/or development. This includes but is not limited to suspected maternal substance abuse such as alcohol or drug. 2. Mother has known gestational diabetes and/or a diagnosis of pre-eclampsia. 3. Mother with contraindications to breastfeeding such as known HIV or conditions that can significantly interfere with breastfeeding such as serious illness as per investigatorâ??s judgment. 4. Mother had a breast surgery. 5. Mother and/or newborn infant has major illness that requires intensive care admission 24 hours. 6. Infant is advised to be kept in NICU and unable to feed from the mother for more than a week or has a medical history that is thought by the investigator to have potential effects on infantâ??s growth and/or development. 7. Infant has major congenital anomaly in the PIâ??s opinion 8. Participation in another study that has not been approved as a concomitant study by AN.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fat content of milkTimepoint: 15, 42 and 98 days post-delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of blood samples from mother for iron, choline, folic acid, prolactin, Vitamins (A, D, B6, B12 and E) and complete blood count (CBC).Timepoint: Baseline, 42, and 98 days post-delivery for iron, choline, folic acid, prolactin, Vitamins (A, D, B6, B12 and E). Baseline and 98 days post-delivery for complete blood count (CBC).;Complete Fatty acid profile of motherâ??s milkTimepoint: 15, 42 and 98 days post-delivery;Energy, macronutrients and micronutrients intake of the mother through her dietTimepoint: FFQ (Food Frequency Questionnaire) at Baseline and 98 days post-delivery;Milk energy, carbohydrate and protein levels and calculated renal solute load (RSL)Timepoint: 15, 42 and 98 days post-delivery;â?? Choline, Vitamins (A, E, B6), lutein, folic acid and key minerals (iron, zinc, sodium, potassium, phosphorus and chloride) content in milk across the duration of lactation and associated socioeconomic-demographic and nutritional factors (including the dietary intake, kind of diet) and anthropometric measuresTimepoint: 15, 42 and 98 days post-delivery;Self-reported pre-pregnancy weight or earliest recorded weightTimepoint: During first trimester from hospital records | — |
Countries
India
Contacts
Public ContactGaurav Verma
Abbott Nutrition International India. Abbott Healthcare Pvt. Ltd.
Outcome results
None listed