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孕期和哺乳期强化均衡能量-蛋白质补充与布基纳法索农村婴儿生长:一项 2×2 析因随机对照试验。

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

机构信息

Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering, Ghent University, Ghent, Belgium.

Department of Population and Family Health, Institute of Health, Jimma University, Jimma, Ethiopia.

出版信息

PLoS Med. 2023 Feb 6;20(2):e1004186. doi: 10.1371/journal.pmed.1004186. eCollection 2023 Feb.

DOI:10.1371/journal.pmed.1004186
PMID:36745684
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9943012/
Abstract

BACKGROUND

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.

METHODS AND FINDINGS

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.

CONCLUSIONS

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.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT03533712.

摘要

背景

从受孕到出生后 2 年的最初 1000 天,是生命关键期,在此期间,最佳营养至关重要。对母亲进行产前和产后补充富含多种微量营养素的能量-蛋白质平衡(BEP)补充剂是一种潜在的营养干预措施。然而,关于 BEP 补充剂对儿童生长的长期影响的证据并不一致。我们评估了在布基纳法索农村地区,妊娠和哺乳期每日强化 BEP 补充对婴儿生长的疗效。

方法和发现

在 Hauts-Bassins 地区的 Houndé 区的 6 个卫生中心集水区实施了一项 2×2 析因随机对照试验(MISAME-III)。2019 年 10 月至 2020 年 12 月,共有 1897 名年龄在 15 至 40 岁之间、妊娠<21 周的孕妇入组。这些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(即干预组)或仅接受 IFA(即对照组),这是妊娠期间的标准护理。同样的妇女被同时随机分配到接受产后干预的组别,产后前 6 个月接受强化 BEP 补充剂,前 6 周同时接受 IFA(即干预组),或产后仅接受 IFA 6 周(即对照组)。补充剂由经过培训的村级项目工作人员在每日家访中进行直接观察。我们之前报道了产前 BEP 补充对出生结局的影响。主要的产后研究结局是 6 个月时的身长-年龄 z 评分(LAZ)。次要结局是生长的人体测量学指标(体重-身长和体重-年龄 z 评分,以及臂围和头围)和营养状况(生长迟缓、消瘦、体重不足、贫血和血红蛋白浓度的流行率)。此外,还评估了常见儿童疾病的纵向患病率、消瘦的发病率、纯母乳喂养的月数以及从出生到 12 个月的人体测量学指标的轨迹。

产前 BEP 补充显著提高了 6 个月时的 LAZ(0.11 标准差(SD),95%置信区间(CI)[0.01 至 0.21],p = 0.032)和降低了生长迟缓的流行率(-3.18 个百分点(pp),95% CI [5.86 至 -0.51],p = 0.020),而产后 BEP 补充对 6 个月时的 LAZ 或生长迟缓没有统计学意义的影响。另一方面,产后 BEP 补充剂在产后第一个 12 个月内每月 LAZ 增量略有改善(0.01 z 评分/月,95% CI [0.00 至 0.02],p = 0.030),但在产前研究组之间没有检测到生长轨迹的差异。此外,除了产前 BEP 干预组在 6 个月时发现体重不足的流行率呈下降趋势(-2.74 pp,95% CI [-5.65 至 1.17],p = 0.065)外,其他次要结局均未受到 BEP 预或产后补充的显著影响。

结论

这项研究提供了证据,表明产前 BEP 补充对出生时大小的益处在婴儿期的线性生长中得到维持。哺乳期母亲 BEP 补充可能会导致婴儿期后半段的线性生长略有改善。这些发现表明,在妊娠期间补充 BEP 可以有助于减少中低收入国家儿童生长不良的高负担。

试验注册

ClinicalTrials.gov:NCT03533712。

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