Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
BMJ Paediatr Open. 2023 Nov;7(1). doi: 10.1136/bmjpo-2023-002229.
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.
许多中低收入国家的妇女在怀孕时营养储备不足，胎儿生长受限和不良出生结局（包括小于胎龄儿[SGA]和早产）的风险增加。平衡能量-蛋白质（BEP）补充剂已显示出降低死产和 SGA 风险的效果，但干预形式和组成的差异以及关于 BEP 在哺乳期对生长结局影响的有限证据需要进一步研究。本文介绍了 Maternal Infant Nutrition Trial（MINT）研究的方案，该研究旨在评估在尼泊尔农村地区，妊娠和哺乳期强化 BEP 补充剂对出生结局和婴儿生长的影响。
MINT 是一项 2×2 析因、家庭随机、非盲、疗效试验，在尼泊尔萨勒希区的一个次区域进行。研究区域覆盖六个农村自治市，约有 27000 户家庭，人口约 10 万。怀孕的已婚妇女（15-30 岁）有资格参加该试验，并在登记时随机分配接受强化 BEP 补充或不补充，在分娩时随机分配接受强化 BEP 补充或不补充，直至产后 6 个月。主要妊娠结局是采用 INTERGROWTH-21st 标准测量的出生体重在 72 小时内的活产婴儿中 SGA 的发生率。主要婴儿生长结局是使用世界卫生组织国际生长参考值在 6 个月时的平均长度-年龄 z 评分。
该研究得到了美国巴尔的摩约翰霍普金斯彭博公共卫生学院机构审查委员会（IRB）（IRB00009714）、美国华盛顿特区乔治华盛顿大学人类研究 IRB（081739）和尼泊尔卫生研究委员会伦理审查委员会的批准，加德满都，尼泊尔（174/2018）。
NCT03668977。
