Improving Infant Neurocognitive Development and Growth Outcomes with Micronutrients (INDiGO)

King's College London0 个研究点目标入组 600 人开始时间: 2021年7月9日最近更新: 2023年1月9日

适应症

试验速览

暂无简介。

•1. Pregnant women aged 18-49 years
•2. Singleton pregnancy at <20 weeks gestation at initial pregnancy confirmation
•3. Healthy, with no evidence of current severe anaemia (haemoglobin >7 g/dl)
•4. Willingness to take a daily trial product (capsule) daily from 20 weeks of pregnancy until 6 months post-partum and for their infant to receive a daily trial product (syrup drops) from Day 8 until 6 months of age

•1. Multiple pregnancy
•2. Pregnancy =20 weeks gestation
•3. Severe anaemia (haemoglobin <7 g/dl)
•4. Any history or evidence of chronic disease (including HIV, TB, hypertension)
•5. Unwilling to avoid the ingestion of other micronutrient supplements during the study period
•Post-partum/infancy:
•1. Very or extremely preterm infants (< 32 weeks gestation at delivery)
•2. Very low birth weight infants (<1.5 kg at delivery)
•3. Infants identified at any follow-up point as having severe-acute malnutrition (weight-for-height z score of <-3SD)
•4. Non-breastfeeding mother-infant pairs
•5. Unwilling to avoid the ingestion of – or for their infant to avoid the ingestion of – other micronutrient supplements during the study period
•6. Any condition of the mother or infant that, in the opinion of the investigator, might compromise the safety or well-being of the participant or compromise adherence to protocol procedures (including the identification of severe neurodevelopmental conditions, such as cerebral palsy)

发起方