Micronutrient interventions to improve infant neurocognitive development and growth in early infancy

Kings College London0 个研究点目标入组 1,200 人开始时间: 2021年10月26日最近更新: 2023年5月29日

试验速览

暂无简介。

•Pregnancy < 20 weeks at initial pregnancy confirmation
•Singleton pregnancy
•Healthy, with no evidence of current severe anaemia
•Willingness to take a daily trial product (capsule) daily from 20 weeks of pregnancy until six-months post-partum and for their infant to receive a daily trial product (syrup drops) from Day 8 until 6 months of age
•Intention to remain resident in West or Central Kiang until the infant is 12 months of age

•Pregnancy phase:
•Multiple pregnancy
•Pregnancy =20 weeks gestation
•Severe anaemia (<7g/dL)
•Any known history or evidence of chronic disease (including HIV, TB, non-pregnancy-induced-hypertension or diabetes). Women will be offered HIV Voluntary Counselling and Testing (as part of routine antenatal care) and, where positive, excluded from the trial
•Unwilling to avoid the ingestion of other micronutrient supplements during the study period
•If the primary language of the mother is not Mandinka or Fula
•Post-partum / Infancy phase:
•Very or extremely preterm infants (< 32 weeks gestation at delivery)
•Very low birth weight infants (<1.5kg at delivery)
•Infants identified at any follow up point as having severe-acute malnutrition (weight-for-height z score of <-3SD)
•Non-breastfeeding mother-infant pairs
•Unwilling to avoid the ingestion of – or for their infant to avoid the ingestion of – other micronutrient supplements during the study period
•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

Kings College London