Abstract：
BACKGROUND: Maternal undernutrition is a direct risk factor for infant growth faltering.
OBJECTIVE: We evaluated the effect of postnatal Balanced Energy Protein (BEP) supplementation in lactating women and Azithromycin (AZ) in infants on infant growth outcomes.
METHODS: A randomized controlled superiority trial of lactating mother-newborn dyads was conducted in Karachi, Pakistan. Mothers intending to breastfeed their newborns with mid-upper arm circumference of less than 23 cm and live infants between 0-6 days of life were randomly assigned to one of three arms in a 1:1:1 ratio. Lactating mothers in the control arm received standard-of-care counseling on exclusive breastfeeding, nutrition, infant immunization and health promotion plus iron-folate supplementation until the infant was 6 months of age. In intervention arm 1, mothers additionally received two 75-gram sachets of BEP per day, while in intervention arm 2 along with the standard-of-care and BEP, the infant also received one dose of Azithromycin (at 20 mg per kilogram) at 42 days of life. The primary outcome was infant length velocity at 6 months. The total sample size was 957 (319 in each arm).
RESULTS: From August 1, 2018 to May 19, 2020, 319 lactating mother-newborn dyads were randomized in each arm, and the last follow-up was completed on November 20, 2020. The mean difference in length velocity (cm per month) between BEP alone and control was 0.01 (95% CI: -0.03, 0.06), BEP plus AZ and control was 0.08 (95% CI:0.03,0.13) and between BEP+AZ and BEP alone was 0.06 (95% CI: 0.01, 0.11). There were 1.46% (14/957) infant deaths in the trial, and 17.9% (171/957) non-fatal events (injectable treatment and/or hospitalizations) were recorded.
CONCLUSIONS: Postnatal maternal BEP supplementation and infant AZ administration could modestly improve infant growth outcomes at 6 months, suggesting potential benefits in simultaneously addressing maternal and infant undernutrition.
UNASSIGNED: This trial is registered on ClinicalTrials.gov NCT03564652 on June 21, 2018.
OBJECTIVE: We evaluated the effect of postnatal Balanced Energy Protein (BEP) supplementation in lactating women and Azithromycin (AZ) in infants on infant growth outcomes.
METHODS: A randomized controlled superiority trial of lactating mother-newborn dyads was conducted in Karachi, Pakistan. Mothers intending to breastfeed their newborns with mid-upper arm circumference of less than 23 cm and live infants between 0-6 days of life were randomly assigned to one of three arms in a 1:1:1 ratio. Lactating mothers in the control arm received standard-of-care counseling on exclusive breastfeeding, nutrition, infant immunization and health promotion plus iron-folate supplementation until the infant was 6 months of age. In intervention arm 1, mothers additionally received two 75-gram sachets of BEP per day, while in intervention arm 2 along with the standard-of-care and BEP, the infant also received one dose of Azithromycin (at 20 mg per kilogram) at 42 days of life. The primary outcome was infant length velocity at 6 months. The total sample size was 957 (319 in each arm).
RESULTS: From August 1, 2018 to May 19, 2020, 319 lactating mother-newborn dyads were randomized in each arm, and the last follow-up was completed on November 20, 2020. The mean difference in length velocity (cm per month) between BEP alone and control was 0.01 (95% CI: -0.03, 0.06), BEP plus AZ and control was 0.08 (95% CI:0.03,0.13) and between BEP+AZ and BEP alone was 0.06 (95% CI: 0.01, 0.11). There were 1.46% (14/957) infant deaths in the trial, and 17.9% (171/957) non-fatal events (injectable treatment and/or hospitalizations) were recorded.
CONCLUSIONS: Postnatal maternal BEP supplementation and infant AZ administration could modestly improve infant growth outcomes at 6 months, suggesting potential benefits in simultaneously addressing maternal and infant undernutrition.
UNASSIGNED: This trial is registered on ClinicalTrials.gov NCT03564652 on June 21, 2018.
摘要：
背景：母体营养不足是婴儿生长迟缓的直接危险因素。
目的：我们评估了哺乳期妇女产后补充平衡能量蛋白（BEP）和婴儿补充阿奇霉素（AZ）对婴儿生长结局的影响。
方法：在卡拉奇进行了一项哺乳期母亲-新生儿双胎的随机对照优势试验，巴基斯坦。打算母乳喂养中上臂周长小于23厘米的新生儿的母亲和生活在0-6天之间的活婴以1：1：1的比例随机分配到三只手臂之一。控制组的哺乳期母亲接受了纯母乳喂养的标准护理咨询，营养,婴儿免疫接种和健康促进以及补充叶酸铁,直至婴儿6个月大.在干预组1中，母亲每天另外接受两袋75克BEP，在第2组的干预中，以及标准护理和BEP，婴儿在42天的生命中还接受了一剂阿奇霉素(20mg/kg).主要结果是6个月时的婴儿身长速度。总样本量为957(每组319个)。
结果：从2018年8月1日至2020年5月19日，在每只手臂中随机分配了319个哺乳期母亲-新生儿双胎，最后一次随访于2020年11月20日完成。单独BEP和对照之间的长度速度（cm/月）的平均差为0.01（95％CI：-0.03，0.06），BEP加AZ和对照为0.08(95%CI:0.03,0.13),单独BEP+AZ和BEP之间为0.06(95%CI:0.01,0.11)。试验中有1.46%(14/957)的婴儿死亡，记录了17.9%(171/957)的非致死性事件(可注射治疗和/或住院).
结论：产后母亲BEP补充和婴儿AZ给药可适度改善婴儿6个月时的生长结局，提示同时解决母婴营养不良的潜在益处。
■该试验于2018年6月21日在ClinicalTrials.govNCT03564652上注册。
目的：我们评估了哺乳期妇女产后补充平衡能量蛋白（BEP）和婴儿补充阿奇霉素（AZ）对婴儿生长结局的影响。
方法：在卡拉奇进行了一项哺乳期母亲-新生儿双胎的随机对照优势试验，巴基斯坦。打算母乳喂养中上臂周长小于23厘米的新生儿的母亲和生活在0-6天之间的活婴以1：1：1的比例随机分配到三只手臂之一。控制组的哺乳期母亲接受了纯母乳喂养的标准护理咨询，营养,婴儿免疫接种和健康促进以及补充叶酸铁,直至婴儿6个月大.在干预组1中，母亲每天另外接受两袋75克BEP，在第2组的干预中，以及标准护理和BEP，婴儿在42天的生命中还接受了一剂阿奇霉素(20mg/kg).主要结果是6个月时的婴儿身长速度。总样本量为957(每组319个)。
结果：从2018年8月1日至2020年5月19日，在每只手臂中随机分配了319个哺乳期母亲-新生儿双胎，最后一次随访于2020年11月20日完成。单独BEP和对照之间的长度速度（cm/月）的平均差为0.01（95％CI：-0.03，0.06），BEP加AZ和对照为0.08(95%CI:0.03,0.13),单独BEP+AZ和BEP之间为0.06(95%CI:0.01,0.11)。试验中有1.46%(14/957)的婴儿死亡，记录了17.9%(171/957)的非致死性事件(可注射治疗和/或住院).
结论：产后母亲BEP补充和婴儿AZ给药可适度改善婴儿6个月时的生长结局，提示同时解决母婴营养不良的潜在益处。
■该试验于2018年6月21日在ClinicalTrials.govNCT03564652上注册。
