Human milk composition in Indian mothers.

Abbott Nutrition Research and Development ANRD India0 个研究点目标入组 248 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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 <= 35 kg/m2 based on self-reported pre-pregnant weight or the earliest measured weight during the first trimester from the hospital record.
•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 <= 37 weeks, by definition are preterm, but is not declared very low birth weight by the pediatrician, and is able to feed from the mother normally.
•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.

•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.

发起方

Abbott Nutrition Research and Development ANRD India