Supplementation with fortified balanced energy-protein during pregnancy and lactation and its effects on birth outcomes and infant growth in southern Nepal: protocol of a 2×2 factorial randomised trial.
Supplementation with fortified balanced energy-protein during pregnancy and lactation and its effects on birth outcomes and infant growth in southern Nepal: protocol of a 2×2 factorial randomised trial.
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DOI：
10.1136/bmjpo-2023-002229
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发表时间：
2023-11
影响因子：
2.6
通讯作者：
中科院分区：
文献类型：
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作者：
低收入和中等收入国家的许多妇女在怀孕时营养储备不足，胎儿生长受限和不良出生结果的风险增加，包括小于胎龄儿（SGA）和早产。平衡能量-蛋白质（BEP）补充剂已显示出死胎和SGA风险的降低，但干预形式和组成的变化以及哺乳期间BEP对生长结果影响的有限证据值得进一步研究。本文介绍了母婴营养试验（MINT）研究的协议，其目的是评估在怀孕和哺乳期间强化BEP补充剂对尼泊尔农村地区出生结局和婴儿生长的影响。MINT是一项在尼泊尔Sarlahi区一个分区进行的2×2析因、家庭随机、非盲、疗效试验。研究区域包括六个农村城市，约有27 000户家庭，人口约100 000人。怀孕的已婚妇女（15-30岁）有资格参加试验，并在入组时随机分配补充或不补充强化的BEP，并在出生时随机分配补充或不补充强化的BEP，直至产后6个月。主要妊娠结局是使用INTERGROWTH-21标准，在分娩后72小时内测量出生体重的活产婴儿中SGA的发生率。主要婴儿生长结局是使用WHO国际生长参考的6个月时平均年龄别身长z评分。本研究已获得美国巴尔的摩约翰霍普金斯大学彭博公共卫生学院机构审查委员会（IRB）（IRB 00009714）、美国华盛顿特区乔治华盛顿大学人类研究委员会IRB（081739）和尼泊尔加德满都尼泊尔健康研究理事会伦理审查委员会（174/2018）的批准。NCT 03668977。
Many women in low and middle-income countries enter pregnancy with low nutritional reserves with increased risk of fetal growth restriction and poor birth outcomes, including small-for-gestational-age (SGA) and preterm birth. Balanced energy–protein (BEP) supplements have shown reductions in risk of stillbirth and SGA, yet variations in intervention format and composition and limited evidence on the impact of BEP during lactation on growth outcomes warrant further study. This paper describes the protocol of the Maternal Infant Nutrition Trial (MINT) Study, which aims to evaluate the impact of a fortified BEP supplement during pregnancy and lactation on birth outcomes and infant growth in rural Nepal. MINT is a 2×2 factorial, household randomised, unblinded, efficacy trial conducted in a subarea of Sarlahi District, Nepal. The study area covers six rural municipalities with about 27 000 households and a population of approximately 100 000. Married women (15–30 years) who become pregnant are eligible for participation in the trial and are randomly assigned at enrolment to supplementation with fortified BEP or not and at birth to fortified BEP supplementation or not until 6 months post partum. The primary pregnancy outcome is incidence of SGA, using the INTERGROWTH-21st standard, among live born infants with birth weight measured within 72 hours of delivery. The primary infant growth outcome is mean length-for-age z-score at 6 months using the WHO international growth reference. The study was approved by the Institutional Review Board (IRB) at Johns Hopkins Bloomberg School of Public Health, Baltimore, USA (IRB00009714), the Committee on Human Research IRB at The George Washington University, Washington, DC, USA (081739), and the Ethical Review Board of the Nepal Health Research Council, Kathmandu, Nepal (174/2018). NCT03668977.
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影响因子：
2.9
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影响因子：
3.4
作者：
Lama, Tsering P.;Khatry, Subarna K.;Isanaka, Sheila;Moore, Katie;Jones, Leslie;Bedford, Juliet;Katz, Joanne;de Pee, Saskia;LeClerq, Steven C.;Tielsch, James M.
通讯作者：
Tielsch, James M.
DOI：
10.1111/1471-0528.17510
发表时间：
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影响因子：
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作者：
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通讯作者：
Black, R. E.
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通讯作者：
Gavidia T
影响因子：
2.8
作者：
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Bhutta, Zulfiqar A.