Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,788
- 试验地点
- 1
- 主要终点
- Length-for-age Z-scores (LAZ)
研究概览
简要总结
The 2016 WHO antenatal care guidelines stated that pregnant women in undernourished populations should receive fortified balanced energy-protein (BEP) supplements to reduce the risk of stillbirth and small-for-gestational-age birth. However, acceptable supplements and delivery channels must be determined for different contexts.
The present proposal therefore will 1) perform a formative study to identify the most suitable (acceptability and utilization) BEP supplement for pregnant women in rural Burkina Faso (phase 1) and 2) evaluate the efficacy of this supplement to improve birth weight, fetal and infant growth (phase 2). The nutritional composition of the BEP supplement was established during an expert convening at the BMGF in September 2016. Private sector partners will prepare the supplements in the selected forms with the recommended nutrient composition.
详细描述
Pregnancy remains a challenging period in the life of many women in low- and middle-income countries. Maternal mortality remains high and many newborns suffer from premature delivery and /or gestational growth retardation both in length and in weight accumulation.
The 2016 WHO antenatal care guidelines stated that pregnant women in undernourished populations should receive fortified balanced energy-protein (BEP) supplements to reduce the risk of stillbirth and small-for-gestational-age birth. However, acceptable supplements and delivery channels must be determined for different contexts.
The purpose of this study is to assess the efficacy of a fortified BEP supplement for pregnant and lactating women to improve birth weight, fetal and infant growth.
This research includes 2 phases:
- Phase 1 - part 1: Formative research to identify preferred product types of a fortified BEP supplement;
- Phase 1 - part 2: Formative research with a 10-week home-feeding trial to determine the acceptability of a fortified BEP supplement for longer-term consumption.
- Phase 2: A community-based, individually randomized efficacy trial of the fortified BEP food supplement including 1,776 pregnant and lactating women aimed at testing 2 hypothesis: supplementing pregnant and lactating women with a fortified BEP supplement will improve fetal growth; improving fetal growth will have a positive effect on health and growth during infancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participant age (15-40 years).
- •Pregnant as determined by a pregnancy test and confirmed by ultrasound.
- •Women who signed the informed consent form (in case of minors the parents or husband signs)
排除标准
- •Women planning to leave the area before delivery.
- •Women who plan to deliver outside the area.
- •Pregnancies with a gestational age > 20 weeks at study inclusion.
- •Women with multi-fetal gestation (exclusion from analysis).
- •Women who are allergic to peanuts.
结局指标
主要结局
Length-for-age Z-scores (LAZ)
时间窗: at 6 months (and 12 months on a subsample)
Mean of Length-for-Age Z-scores (LAZ), WHO multi-country reference.
Small-for-Gestational-age (SGA)
时间窗: within 72h after birth
Incidence of Small-for-Gestational-age (SGA) defined as \<10th centile of birthweight for gestational age standard, InterGrowth 21st reference.
次要结局
- Child mortality(between birth and 6 months of age)
- Child weight gain(over first 6 months of life)
- Monthly change in head circumference(over first 6 months of life)
- Exclusive breastfeeding(during the first 6 months of life)
- Birth weight(within 72h after birth)
- Chest circumference(within 72h after birth)
- Neonatal mortality(between birth and ≤ 28 days of life)
- Ponderal or Rohrer's index'(within 72 hours after birth)
- Gestational weight change(between study inclusion until 1 month after delivery)
- Birth length(within 72h after birth)
- Mid-upper arm circumference(within 72h after birth)
- Prenatal weight gain(between study inclusion until just before delivery)
- Head circumference(within 72h after birth)
- Gestational age(at delivery)
- Preterm birth(at delivery)
- Large-for-gestational age(within 72h after birth)
- Fetal loss(during pregnancy)
- Stillbirths(during pregnancy)
- Women's minimum and mean dietary diversity score(from study inclusion until delivery)
- Weight-for-Age Z-score(at 6 months of age)
- Monthly change in LAZ(over first 6 months of life)
- Monthly change in WHZ(over first 6 months of life)
- Underweight(at 6 months of age)
- Probable and possible maternal postnatal depression((1) at 2 months of child age; (2) at 6 months of child age)
- Stunting(at 6 months of age)
- Maternal anemia(at the third antenatal consultation)
- Weight-for-Length Z-score(at 6 months of age)
- Wasting(at 6 months of age)
- Incidence of child wasting(over first 6 months of life)
- Relative average telomere length(At birth)
- Monthly change in WAZ(over first 6 months of life)
- Child morbidity symptoms(over first 6 months of life)
- Infant body composition(first 3 months of life)
- Child anemia(at 6 months of age)
- Hemoglobin concentration(at 6 months of age)
- Maternal body composition(first 3 months after delivery)
- Breast milk composition(between 1-2 and 3-4 months)
研究者
VakgroepLevensmiddelentechnologieVoedselveiligheidGezondheid
Prof. dr. Patrick Kolsteren
University Ghent