Effect on Pregnancy Outcomes, Infant Growth and Development of an Egg Intervention During Pregnancy in Indonesia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 702
- 试验地点
- 1
- 主要终点
- Proportion of children 10-14 months with impaired expressive and receptive language
研究概览
简要总结
The study consists of two arms: 1) intervention group using eggs as supplementary food given from 2nd trimester of pregnancy to birth, and 2) observational group of pregnant mothers. it aims to assess the effectiveness of improving dietary quality during pregnancy on the epigenetic and stunting related outcomes (growth and development) in infants, who will be followed up until 24 months old
详细描述
The study aims to assess the impact of improving dietary quality during pregnancy on the epigenetic and stunting related outcomes in infants. The open-label intervention study would be conducted alongside the observational study in the same study setting by recruitment of additional number (n=153) of pregnant women. Thus, a total of 653 pregnant women would be enrolled in the study; 153 women would be randomized to intervention arm and 500 to the control arm who would form an observational cohort of women and newborns as described above. The intervention group women will be provided one egg three times per week from recruitment (2nd trimester) until term. The control group women will receive standard intervention in the form of Ante Natal Care from village midwives or Public Health Centre (IFA tablet, calcium tablet, nutrition counselling).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman is between 16 and 20 weeks of pregnancy based on the date of the first day of her last menstrual period.
- •She is 18-40 years of age.
- •She is planning to remain in the study area over the next 30 months.
- •She is of Sasak ethnicity
排除标准
- •She is expecting multiple births.
- •She has a known egg allergy.
结局指标
主要结局
Proportion of children 10-14 months with impaired expressive and receptive language
时间窗: 10-14 months of age
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess expressive and receptive language among children aged 10 to 14 months
Proportion of children 10-14 months with impaired empathy
时间窗: 10-14 months of age
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess empathy among children aged 10 to 14 months
Proportion of children 20-24 months with impaired motor development
时间窗: 20-24 months of age
INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess motor development among children aged 20 to 24 months
Proportion of children 20-24 months with impaired social-emotional development
时间窗: 20-24 months of age
INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess social-emotional development among children aged 20 to 24 months
Scores of CDI vocabulary comprehension scale in children 10-12 months
时间窗: 10-12 months of age
MacArthur-Bates Communicative Development Inventories (CDI) is used to assess vocabulary comprehension scale among children aged 10 to 12 months
Prevalence of stunting
时间窗: birth until 24 months after delivery
Z-score of LAZ \<-2 SD based on WHO 2006
Proportion of children 10-14 months with impaired fine and gross motor skills
时间窗: 10-14 months of age
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess fine and gross motor skills among children aged 10 to 14 months
Proportion of children 10-14 months with impaired attention
时间窗: 10-14 months of age
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess attention among children aged 10 to 14 months
Proportion of children 20-24 months with impaired cognition
时间窗: 20-24 months of age
INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess cognition among children aged 20 to 24 months
Proportion of children 20-24 months with impaired language
时间窗: 20-24 months of age
INTERGROWTH Neurodevelopment Assessment (INTER-NDA) is used to assess language among children aged 20 to 24 months
Proportion of children 10-14 months with impaired executive function
时间窗: 10-14 months of age
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess executive function among children aged 10 to 14 months
Proportion of children 10-14 months with impaired problem solving
时间窗: 10-14 months of age
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess problem solving among children aged 10 to 14 months
Proportion of children 10-14 months with impaired behavior
时间窗: 10-14 months of age
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess behavior among children aged 10 to 14 months
Scores of CDI vocabulary production scale in children 10-12 months
时间窗: 10-12 months of age
MacArthur-Bates Communicative Development Inventories (CDI) is used to assess vocabulary production among children aged 10 to 12 months
Proportion of children 10-14 months with impaired social-emotional reactivity
时间窗: 10-14 months of age
Oxford Neurodevelopment Assessment (OX-NDA) is used to assess social-emotional reactivity among children aged 10 to 14 months
Epigenetic state of genes associated with stunting
时间窗: parents: 72 h after delivery; baby: 72 h after delivery, 24 month
Genome-wide analysis of epigenetic states using the Illumina Infinium Methylation EPIC 850k Bead Chip (EPIC array) will be performed for selected samples from the core cohort. The outcomes will be the epigenetic state of a large number of genes which are associated with child stunting.
Epigenetic markers of birth anthropometry, adult stature, metabolic state, and cognitive ability
时间窗: parents: 72 h after delivery; baby: 72 h after delivery, 24 month
All samples (newborn, children 24 mo, parents) will be analyzed using Next Generation Bisulphite Amplicon Sequencing (BSAS) from Illumina MiSeq platform in targeted regions of the genome. The outcomes will be profiles of specific epigenetic markers of birth anthropometry, adult stature, metabolic state, and cognitive ability.
次要结局
- Birth length(24 hours after birth)
- Serum zinc concentration(Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery)
- Serum methylmalonic acid concentration(Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery)
- Serum CRP concentration(Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery)
- Serum AGP concentration(Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery)
- Gut microbiota(baby: 1, 6, 24 months of age)
- Intestinal fatty acid binding protein(baby: 6 months of age)
- Serum vitamin B12 concentration(Mothers: second and third trimester of pregnancy)
- RBC fatty acids concentration(Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery)
- Serum betaine concentration(Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery)
- Serum vitamin B2 concentration(Mothers: second and third trimester of pregnancy)
- Serum vitamin B6 concentration(Mothers: second and third trimester of pregnancy)
- Serum vitamin D concentration(Mothers: second and third trimester of pregnancy)
- Weight gain during pregnancy(2nd trimester (16-20 weeks gestation) and 3rd trimester (28-32 weeks gestation) of pregnancy)
- Birth weight(24 hours after birth)
- Hemoglobin concentration(Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery)
- Serum ferritin concentration(Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery)
- Serum transferrin receptor concentration(Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery)
- Serum retinol concentration(Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery)
- RBC folate concentration(Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery)
- Serum choline concentration(Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery)
- Serum essential amino acids concentration(Mothers: second and third trimester of pregnancy)
- Serum RBP concentration(Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery)
- Serum homocysteine concentration(Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery)
- Serum HbA1C concentration(Mothers: second and third trimester of pregnancy)
- Fecal α1-antitrypsin (AAT)(baby: 1, 6, 24 months of age)
- Serum hepcidine concentration(Mothers: second and third trimester of pregnancy; children: 6 months (+/- 2 weeks) after delivery; breastmilk: 3 and 6 months (+/- 2 weeks) after delivery)
- Bacteria infection(baby: 1, 6, 24 months of age)
- Fecal myeloperoxidase (MPO)(baby: 1, 6, 24 months of age)
- Soil-transmitted helminths infection(mothers: 3rd trimester (28-32 gestational weeks) of pregnancy; baby: 1, 6, 24 months of age)
- Gut microbiome(baby: 1, 6, 24 months of age)
研究者
Dr.Umi Fahmida
Senior Researcher
SEAMEO Regional Centre for Food and Nutrition