Fortified balanced energy-protein supplementation during pregnancy and lactation and infant growth in rural Burkina Faso: A 2 × 2 factorial individually randomized controlled trial.

Fortified balanced energy-protein supplementation during pregnancy and lactation and infant growth in rural Burkina Faso: A 2 × 2 factorial individually randomized controlled trial.
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布基纳法索农村地区妊娠期、哺乳期和婴儿生长期间强化平衡能量蛋白补充:一项 2 × 2 析因单独随机对照试验。

DOI:
10.1371/journal.pmed.1004186
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发表时间:
2023-02
期刊:
影响因子:
15.8
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中科院分区:
医学1区
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从受孕前 1,000 天到出生后 2 年内的关键时期,最佳营养至关重要。母亲产前和产后补充多种微量营养素强化的平衡能量蛋白(BEP)补充剂是一种潜在的营养干预措施。然而,关于补充 BEP 对儿童生长的长期影响的证据并不一致。我们评估了布基纳法索农村地区怀孕和哺乳期间每日强化 BEP 补充剂对婴儿生长的功效。在 Hauts-Bassins 地区 Houndé 区的 6 个卫生中心服务区实施了一项 2 × 2 析因单独随机对照试验 (MISAME-III)。 2019年10月至2020年12月,共招募了1,897名年龄在15至40岁、胎龄<21周的孕妇。妇女被随机分配到产前干预组,接受强化 BEP 补充剂和铁叶酸 (IFA) 片剂(即干预)或单独接受 IFA(即对照),这是怀孕期间的标准护理。这些女性同时随机接受产后干预(包括产后前 6 个月内强化 BEP 补充剂,并结合前 6 周的 IFA)或产后对照(包括产后 6 周单独使用 IFA)(即对照)。补充品由经过培训的村级项目工作人员在日常家访期间在直接观察下提供。我们之前报道过产前 BEP 补充剂对出生结果的影响。主要的产后研究结果是 6 个月大时的年龄别身长 z 评分 (LAZ)。次要结果是 6 个月时的人体测量生长指数(身长别体重和年龄别体重 z 分数,以及臂围和头围)和营养状况(发育迟缓、消瘦、体重不足、贫血和血红蛋白浓度的发生率)。此外,还评估了常见儿童疾病的纵向患病率、消瘦发生率、纯母乳喂养的月数以及从出生到 12 个月的人体测量指数轨迹。产前补充 BEP 可显着提高 6 个月龄时的 LAZ(0.11 标准差 (SD)、95% 置信区间 (CI) [0.01 至 0.21],p = 0.032)和较低的发育迟缓率(−3.18 个百分点 (pp)、95% CI [−5.86 至 -0.51],p = 0.020),而产后补充 BEP 则显着降低对 6 个月时的 LAZ 或发育迟缓没有统计学上的显着影响。另一方面,产后补充 BEP 确实略微改善了产后前 12 个月的 LAZ 每月增量率(0.01 z 得分/月,95% CI [0.00 至 0.02],p = 0.030),而产前研究组之间的生长轨迹没有差异。此外,除了 6 个月时产前 BEP 干预发现的体重不足发生率较低的趋势(-2.74 pp,95% CI [-5.65 至 1.17],p = 0.065)之外,产前或产后 BEP 补充没有显着影响其他次要结局。这项研究提供的证据表明,产前补充 BEP 对出生时体型的益处在婴儿期的线性生长方面得以持续。哺乳期母亲补充 BEP 可能会导致婴儿期后半期的线性生长稍好一些。这些发现表明,怀孕期间补充 BEP 有助于减轻低收入和中等收入国家儿童生长迟缓的沉重负担。 ClinicalTrials.gov:NCT03533712。 Carl Lachat 及其同事报告了一项在布基纳法索农村地区进行的 2×2 析因单独随机对照试验,该试验研究了怀孕和哺乳期间强化平衡能量蛋白补充剂对婴儿生长的影响。出生后 1000 天内的生长缓慢是一个全球性公共卫生问题,与儿童死亡风险增加、发育结果不佳、学业成绩不佳和晚年收入下降密切相关。母亲产前和产后补充多种微量营养素强化平衡能量蛋白(BEP)补充剂是一种潜在的营养干预措施,可防止低收入和中等收入国家在此机会窗口期间承受生长迟缓的沉重负担。然而,迄今为止,为孕妇和哺乳期妇女提供 BEP 补充剂对儿童生长的影响并不一致。因此,迫切需要高质量的实验研究来评估 BEP 补充剂对胎儿和婴儿生长结果的功效。我们在布基纳法索农村进行了一项单独随机对照疗效试验 (MISAME-III),以评估在怀孕和哺乳期间补充强化 BEP 的母亲对其婴儿生长的影响。我们的试验表明,产前补充 BEP 所带来的出生时体型的改善在 6 个月大时仍呈线性增长。此外,我们提供的证据表明,产后 6 个月补充 BEP 可能会导致婴儿期后半段的线性生长稍好一些。我们的研究结果表明,通过将干预措施扩展到生命的前 1,000 天,包括在婴儿和幼儿喂养期间补充 BEP,可以充分利用 BEP 补充剂对线性生长的益处。 MISAME-III 的未来研究将评估其他母婴生化参数,以进一步了解 BEP 补充剂的临床相关性,包括对母乳成分的潜在影响。
Optimal nutrition is crucial during the critical period of the first 1,000 days from conception to 2 years after birth. Prenatal and postnatal supplementation of mothers with multimicronutrient-fortified balanced energy–protein (BEP) supplements is a potential nutritional intervention. However, evidence on the long-term effects of BEP supplementation on child growth is inconsistent. We evaluated the efficacy of daily fortified BEP supplementation during pregnancy and lactation on infant growth in rural Burkina Faso. A 2 × 2 factorial individually randomized controlled trial (MISAME-III) was implemented in 6 health center catchment areas in Houndé district under the Hauts-Bassins region. From October 2019 to December 2020, 1,897 pregnant women aged 15 to 40 years with gestational age <21 completed weeks were enrolled. Women were randomly assigned to the prenatal intervention arms receiving either fortified BEP supplements and iron–folic acid (IFA) tablets (i.e., intervention) or IFA alone (i.e., control), which is the standard of care during pregnancy. The same women were concurrently randomized to receive either of the postnatal intervention, which comprised fortified BEP supplementation during the first 6 months postpartum in combination with IFA for the first 6 weeks (i.e., intervention), or the postnatal control, which comprised IFA alone for 6 weeks postpartum (i.e., control). Supplements were provided by trained village-based project workers under direct observation during daily home visits. We previously reported the effect of prenatal BEP supplementation on birth outcomes. The primary postnatal study outcome was length-for-age z-score (LAZ) at 6 months of age. Secondary outcomes were anthropometric indices of growth (weight-for length and weight-for-age z-scores, and arm and head circumferences) and nutritional status (prevalence rates of stunting, wasting, underweight, anemia, and hemoglobin concentration) at 6 months. Additionally, the longitudinal prevalence of common childhood morbidities, incidence of wasting, number of months of exclusive breastfeeding, and trajectories of anthropometric indices from birth to 12 months were evaluated. Prenatal BEP supplementation resulted in a significantly higher LAZ (0.11 standard deviation (SD), 95% confidence interval (CI) [0.01 to 0.21], p = 0.032) and lower stunting prevalence (−3.18 percentage points (pp), 95% CI [−5.86 to −0.51], p = 0.020) at 6 months of age, whereas the postnatal BEP supplementation did not have statistically significant effects on LAZ or stunting at 6 months. On the other hand, postnatal BEP supplementation did modestly improve the rate of monthly LAZ increment during the first 12 months postpartum (0.01 z-score/month, 95% CI [0.00 to 0.02], p = 0.030), whereas no differences in growth trajectories were detected between the prenatal study arms. Furthermore, except for the trend towards a lower prevalence of underweight found for the prenatal BEP intervention at 6 months (−2.74 pp, 95% CI [−5.65 to 1.17], p = 0.065), no other secondary outcome was significantly affected by the pre- or postnatal BEP supplementation. This study provides evidence that the benefits obtained from prenatal BEP supplementation on size at birth are sustained during infancy in terms of linear growth. Maternal BEP supplementation during lactation may lead to a slightly better linear growth towards the second half of infancy. These findings suggest that BEP supplementation during pregnancy can contribute to the efforts to reduce the high burden of child growth faltering in low- and middle-income countries. ClinicalTrials.gov: NCT03533712. Carl Lachat and colleagues report a a 2×2 factorial individually randomized controlled trial conducted in rural Burkina Faso which investigates the impact of fortified balanced energy-protein supplementation during pregnancy and lactation on infant growth. Growth faltering during the first 1,000 days is a global public health problem, which is strongly associated with an increased risk of child mortality and poor developmental outcomes, as well as poor school performance and lower earning in later life. Prenatal and postnatal supplementation of mothers with multiple micronutrient-fortified balanced energy–protein (BEP) supplements is a potential nutritional intervention to prevent the high burden of growth retardation during this window of opportunity in low- and middle-income countries. However, the effect of providing pregnant and lactating women with BEP supplements on child growth is inconsistent to date. Hence, there is a critical need for high-quality experimental studies to assess the efficacy of BEP supplements on fetal and infant growth outcomes. We conducted an individually randomised controlled efficacy trial in rural Burkina Faso (MISAME-III) to assess the effect of supplementing mothers with fortified BEP during pregnancy and lactation on the growth of their infants. Our trial indicates that the improvements in size at birth accrued from prenatal BEP supplementation are sustained in terms of linear growth at the age of 6 months. In addition, we provide evidence that maternal BEP supplementation for 6 months postpartum might lead to a slightly better linear growth towards the second half of infancy. Our findings suggest that the benefits of BEP supplementation on linear growth might be fully exploited by extending the intervention to cover the first 1,000 days of life, which includes supplementation of infants and young children during the complementary feeding period. Future research in MISAME-III will assess additional maternal and child biochemical parameters to provide further insights into the clinical relevance of BEP supplementation, including the potential impacts on breast milk composition.
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