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一项针对南非母乳喂养儿童未来合生元试验的基于粉末的补充剂的纵向观察研究。

A Longitudinal Observational Study of a Powder-Based Supplement for a Future Synbiotic Trial in Breastfed Children From South Africa.

作者信息

Shivakoti Rupak, Laughton Barbara, Shafiq Mehr, Schoeman Elisma, Glashoff Richard H, Barnabas Shaun, Fry Samantha, Leu Cheng-Shiun, Wang Shuang, Bode Lars, Aldrovandi Grace, Kuhn Louise, Slogrove Amy L

机构信息

Department of Epidemiology, Mailman School of Public Health, Columbia University Irving Medical Center, New York, NY, USA.

Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.

出版信息

Sage Open Pediatr. 2025 Feb 21;12:30502225251309003. doi: 10.1177/30502225251309003. eCollection 2025 Jan-Dec.

Abstract

This study investigates the feasibility and acceptability of a powder-based supplement for breastfeeding HIV-exposed uninfected children to inform a larger trial (MIGH-T MO study). Ten mothers living with HIV and their children (6 weeks-20 months) at Tygerberg Hospital, Cape Town, South Africa, participated. The children received a daily supplement of potato maltodextrin mixed with expressed breast milk for 4 weeks, serving as a placebo control for the upcoming trial. Outcomes assessed included feasibility, acceptability, adherence, and health effects, evaluated at enrollment, during weekly calls, and at the 4-week visit. High acceptability was indicated by full enrollment of eligible participants, though there was some loss to follow-up (n = 3). Among the remaining participants, no major feasibility issues were found regarding procedures, product administration, adherence, tolerance, or health assessments. The study concludes that powder-based supplements are feasible and acceptable for breastfeeding HEU children, supporting the potential for larger studies using similar supplements.

摘要

本研究调查了一种基于粉末的补充剂用于母乳喂养的暴露于HIV但未感染儿童的可行性和可接受性,以为一项更大规模的试验(MIGH-T MO研究)提供信息。南非开普敦泰格伯格医院的10位感染HIV的母亲及其子女(6周龄至20个月)参与了研究。这些儿童连续4周每天接受与挤出的母乳混合的马铃薯麦芽糊精补充剂,作为即将进行的试验的安慰剂对照。评估的结果包括可行性、可接受性、依从性和健康影响,在入组时、每周电话随访期间以及4周访视时进行评估。尽管有部分失访(n = 3),但符合条件的参与者全部入组表明可接受性较高。在其余参与者中,未发现有关程序、产品给药、依从性、耐受性或健康评估的重大可行性问题。该研究得出结论,基于粉末的补充剂对于母乳喂养的暴露于HIV但未感染儿童是可行且可接受的,这为使用类似补充剂进行更大规模研究提供了可能性。

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