Evaluating Effectiveness of Benazir Nashonuma Program (BNP) on Maternal and Infant Outcomes: A Non-randomized Intervention Study in Sindh and Punjab
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,500
- 试验地点
- 1
- 主要终点
- Prevalence of low birthweight
研究概览
简要总结
The purpose of this study is to evaluate the impact of Benazir Nashonuma Program (BNP) which includes specialized nutritious food (SNF) augmented with specific reproductive health interventions during pregnancy on proportion of low birthweight babies and stunting among children, in low income setting of Pakistan. The study aims to answer if:
- Utilization of Benazir Nashonuma Program (BNP) among pregnant women is effective in reducing the proportion of low birthweight babies, compared to pregnant women who are not utilizing the program, among low income setting population.
- Utilization of Benazir Nashonuma Program (BNP) is effective in reducing the proportion of stunting among children, compared to those not utilizing the program, among low income setting population.
Participants who are enrolled in the Benazir Nashonuma Program (receiving intervention) and those who are not enrolled (not receiving intervention) will be followed throughout pregnancy till delivery. After delivery mother-baby dyad will be followed for a period of 12 months. Compliance of supplementation will be measured, and outcomes (low birthweight and stunting) observed throughout the follow up.
详细描述
Malnutrition in Pakistan is a major and pervasive public health issue. Every four under five children in our country are reported to be stunted, with a mighty prevalence of 40.2% stunting as reported in the National Nutritional Survey of Pakistan 2018. Pakistan also shares one of the highest burden of low birthweight (LBW) where 19% babies in urban and 32% in rural are born with weight <2500 grams. LBW babies have a higher risk of death compared to full term babies and contributes to 60-80% of all neonatal deaths.
The first 1000 days of life, the time from conception to 2 years of age, is a critical period, providing a window of opportunity for interventions to improve maternal and child nutrition and health outcomes including stunting and other nutritional markers. Availability and access to primary healthcare and nutrition services during pregnancy and the first two years of life can help prevent undernutrition and reduce infections in early life, helping reduce maternal and infant mortality, and preventing the lifelong and intergenerational consequences of malnutrition. Evidence-based nutrition interventions, especially the combination of BEP and small quantity lipid nutrient supplements have been shown to be effective in improving birth outcomes and reducing child stunting.
BNP is a health and nutrition CCT programme, with the aim to address stunting in children under 23 months of age. The CCT and Specialized Nutritious Food (SNF) are provided to Benazir Income Support Programme (BISP) participating women during pregnancy and lactation up to 6 months and to children aged 6-23 months contingent on their participation in and adherence to BNP interventions. In addition to the programme components, the pre-existing standard of care interventions including antenatal and postnatal care, childhood immunizations, growth monitoring and behavior change communication (BCC) activities, i.e., awareness sessions on health, nutrition and hygiene.
The primary study objectives are to assess the impact of intervention (BNP) on:
- Proportion of babies born with low birthweight.
- Prevalence of stunting among infants at 6 and 12 months of age
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Intervention arm: All pregnant women in their first or second trimester, who are enrolled in Benazir Nashonuma Program (BNP).
- •Non-intervention arm: All pregnant women in their first or second trimester, who are not enrolled in Benazir Nashonuma Program (BNP).
排除标准
- •Women who intend to migrate or relocate for more than 3 months during the study period will be excluded from the study.
- •Women in the non intervention group who are consuming specialized nutritious food (SNF) from any source at the time of enrollment will be excluded from the study.
结局指标
主要结局
Prevalence of low birthweight
时间窗: Within 48-hours of delivery
Birth weight of less than 2500 g (up to and including 2499 g) within 48 hours of delivery
Prevalence of stunting
时间窗: At 12 months of age
Height-for-age ≤-2 SD of the WHO Child growth standards median
次要结局
- Prevalence of infants who were exclusively breastfed(At 12 months of age)
- Prevalence of infants with minimum dietary diversity(At 12 months of age)
- Prevalence of wasting(At 6 and 12 months of age)
- Number of women who had Postnatal care (PNC) check ups(3 months after delivery)
- Mean nutrient intake of energy in kilocalories of the pregnant woman(At 9th month of pregnancy)
- Number of women who had Skilled birth attendance(At delivery)
- Prevalence of infants who consumed a minimum acceptable diet(At 12 months of age)
- Mean scores of Neurodevelopmental outcomes of the infant(At 12 months of age)
- Prevalence of Iron deficiency anemia in infants(2 point times: At 6 and 12 months of age)
- Number of antenatal care (ANC) visits during pregnancy(At delivery)
- Prevalence of infants who were ever breastfed(At 12 months of age)
- Prevalence of Iron deficiency anemia in pregnant women(At 9th month on pregnancy)
- Number of women who had an Institutional delivery(At delivery)
- Prevalence of infants who had early initiation of breastfeeding(At 12 months of age)
- Number of infants consuming specialized nutritious food (SNF)(At 12 months of age)
- Number of women consuming specialized nutritious food (SNF)(At 6 months after delivery)
研究者
Dr Zulfiqar Ahmed Bhutta
Distinguished University Professor and Founding Director of the Institute for Global Health and Development and the Centre of Excellence in Women and Child Health
Aga Khan University