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Идёт набор NCT05836961

Impact of Benazir Nashonuma Program (BNP) on Maternal and Child Nutritional Status

Без фазы С лечением Low Birthweight Stunting Wasting Malnutrition, Child

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Benazir Nashonuma Program (BNP).
Кому может быть актуально
Состояния в реестре: Low Birthweight, Stunting, Wasting, Malnutrition, Child. Базовые параметры: 18 лет — 49 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пакистан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluating Effectiveness of Benazir Nashonuma Program (BNP) on Maternal and Infant Outcomes: A Non-randomized Intervention Study in Sindh and Punjab

Обзор

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: 1. 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. 2. 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.

Подробное описание

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

The secondary objectives related to maternal outcomes are to assess the impact of intervention on:

* Dietary diversity of women * Mean nutrient intake including energy in kilo calories. * Prevalence of iron deficiency anemia among lactating women. * Proportion of pregnant women using reproductive health services.

The secondary objectives related to newborn and infant outcomes are to assess the impact of the intervention on:

* Prevalence of wasting among infants at 6 and 12 months of age. * Incidence of anemia among infants at 6- and 12-months of age * Infant and child feeding practices among infants at 6 and 12 months of age. * Neurodevelopmental outcomes (cognitive, language and motor development) using Bayley Scales of Infant and Toddler Development (BSID-IV) at 6 months, and 12 months of age among children.

Other objectives include following:

* To measure receipt and utilization of BEP supplementation among pregnant and lactating women enrolled in BNP. * To measure receipt and utilization on BEP supplementation among children under 12 months of age enrolled in BNP * Household food insecurity status (using the Food Insecurity Experience Scale).

Вмешательства

  • Другое Benazir Nashonuma Program (BNP)
    Dietary supplement for pregnant women and lactating mothers during the first six months of lactation: Maamta is a 75-gram sachet made from peanut butter with 400 kcal of energy Dietary supplement for children aged 6-23 months: Wawamum is a lipid-based nutrient supplement consisting of skimmed milk powder, micronutrients, vegetable oil, roasted chickpeas and antioxidants. Wawamum covers the recommended daily dose of most micronutrients and 255 kcal of energy (1/4 of daily energy requirements f

Первичные конечные точки

  • Prevalence of low birthweight [Срок оценки: Within 48-hours of delivery]
  • Prevalence of stunting [Срок оценки: At 6 months of age]
  • Prevalence of stunting [Срок оценки: At 12 months of age]
Вторичные конечные точки (12)
  • Prevalence of wasting [Срок оценки: At 6 and 12 months of age]
  • Prevalence of Iron deficiency anemia in pregnant women [Срок оценки: At 9th month on pregnancy]
  • Prevalence of Iron deficiency anemia in infants [Срок оценки: 2 point times: At 6 and 12 months of age]
  • Number of antenatal care (ANC) visits during pregnancy [Срок оценки: At delivery]
  • Number of women who had an Institutional delivery [Срок оценки: At delivery]
  • Number of women who had Skilled birth attendance [Срок оценки: At delivery]
  • Number of women who had Postnatal care (PNC) check ups [Срок оценки: 3 months after delivery]
  • Mean nutrient intake of energy in kilocalories of the pregnant woman [Срок оценки: At 9th month of pregnancy]
  • Prevalence of infants who were ever breastfed [Срок оценки: At 12 months of age]
  • Prevalence of infants who had early initiation of breastfeeding [Срок оценки: At 12 months of age]
  • Prevalence of infants who were exclusively breastfed [Срок оценки: At 12 months of age]
  • Prevalence of infants who consumed a minimum acceptable diet [Срок оценки: At 12 months of age]

Критерии участия

Критерии включения

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).

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Пакистан · 1 центр
  • Aga Khan Office — Dadu

Идентификаторы

NCT: NCT05836961 · BNP Study

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗