CTRI/2013/04/003566招募中未知
Vitamin D supplementation to improve immune responses to vaccines administered in early infancy â?? The Nutrivac-D trial
Department of Biotechnology0 个研究点目标入组 900 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Pregnant women will be checked for inclusion criteria during pregnancy & labour, after birth when breastfeeding is established within the first 24 hours.
- •Inclusion criteria during pregnancy and labour are:
- •1. Pregnant at any gestation when screened antenatally; Pregnancy full term ( > 37 and < 41 completed weeks) when screened again at labour (consent will only be taken in the antenatal period and not during labour)
- •2. Will stay in study area for a period of at least 6 months after delivery
- •3. Delivery by vaginal route or by elective cesarian section
- •Inclusion criteria at birth and within 24 hours:
- •1. Single term newborn (gestational age > 37 and < 41 weeks at birth) < 24 hours old.
- •2. Born by normal vaginal route or elective caesarean section.
- •3. Will stay in study area for a period of atleast 6 months after delivery
- •4. Breastfeeding established.
排除标准
- •Exclusion criteria during pregnancy and intrapartum period.
- •1. A mother with a history of > 5 pregnancies.
- •2. Multiple gestation.
- •3. Presence of any documented major maternal medical or surgical illness e.g. HIV, Hepatitis B, Tuberculosis, TORCH infections, syphilis, malignancy or immunodeficiency, etc.
- •4. Presence of fetal (major) congenital anomalies diagnosed in utero.
- •5. Any infection during pregnancy that required hospitalization.
- •6. Blood transfusion during pregnancy.
- •7. History of maternal eclampsia / preeclampsia / hypertension with significant proteinuria ( > 3+) during pregnancy.
- •Exclusion criteria at birth and within 24 hrs:
- •1. One minute Apgar of < 7/10.
- •2. Birth weight < 1.8 kg.
- •3. Multiple gestation.
- •4. Major congenital anomalies diagnosed prior to birth or during a clinical examination by a
- •pediatrician performed within the first 24 hours.
- •5. Newborn required admission to neonatal intensive care prior to randomization.
- •6. Informed written consent not provided by parents.
研究者
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