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临床试验/NCT05959460
NCT05959460已完成不适用

Validation of Maternal Recall of Exclusive Breastfeeding by the Deuterium Dilution Method: a Study in 7 Asian Countries

Mahidol University0 个研究点目标入组 206 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
206
主要终点
Non-milk oral intake

研究概览

简要总结

This study was a longitudinal design. The questionnaire on exclusive breastfeeding was administered and was validated against the deuterium oxide dose-to-mother technique to assess human milk intake of babies aged 3 and 6 mo.

详细描述

This study is a longitudinal design that aimed to assess exclusive breastfeeding (EBF) practices in Asian countries and to compare the agreement in EBF between maternal recall and the dose-to-mother technique (DTM) technique. The questionnaire on exclusive breastfeeding was administered and was validated against the deuterium oxide dose-to-mother technique to assess human milk intake of babies aged 3 and 6 mo. The study planned to recruit 30 mother-baby pairs from each participated country. The was carried out in 7 countries in Asia, namely, Indonesia, Malaysia, Mongolia, Pakistan, Sri Lanka, Thailand, and Vietnam.

Mothers were approached at child birth, to explain the project objective and obtain written informed consent. A screening questionnaire was administered to obtain the interest to participate in the study. Only mothers who intend to exclusive breastfeeding till 6 mo will be eligible for further information and sample collection. Isotope dosing of mothers and saliva sample collection were done when the baby is at 3 mo ± 1wk, when a questionnaire (validation questionnaire) was administered. A basal saliva sample was collected prior to dosing with deuterium oxide. The isotope dosing of the mother was given and saliva samples were collected (post-dose) on day 1,2,3,4 and days 13,14.

The mother-baby pairs were followed up for another sample collection at 6 mo ± 1 wk and all procedures were repeated, including a questionnaire administration, basal sample collection, deuterium oxide dose administration, and post-dose sample collection. Body weight and height/length of mothers and infants were measured. All saliva samples were analyzed by Isotope ratio mass spectrometer (IRMS) or Fourier Transform Infrared Spectroscopy (FTIR).

Quantity of breast milk intake, non milk oral intake (NMOI) and maternal body composition were determined using standard assumption and formulae developed by the International Atomic Energy Agency (IAEA). Children with NMOI ≥ 86.6 g/day were considered as non-EBF using stable isotopic DTM technique. The overall agreement of EBF classification between the recall and DTM techniques is presented using Kappa statistic with 95% confidence interval.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Months 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Mother who practice exclusive breastfeeding
  • Age of mother 18 - 40 years
  • Parity: no more than 3
  • Baby 3 month ± 7 days
  • Nutritional status Weight-for-height Z score (WHZ) > -2
  • Full term baby (37 - 40 weeks)

排除标准

  • Twin or more baby
  • Low birth weight
  • Baby with oedema
  • Mother with fluid retention disease (kidney disease, heart disease, hypothyroidism)
  • Smoking mother
  • Drinking alcohol mother

结局指标

主要结局

Non-milk oral intake

时间窗: Jan 2016 - Dec 2020

Quantity of non-milk oral intake (g)

Human milk intake

时间窗: Jan 2016 - Dec 2020

Quantity of milk intake (g)

次要结局

  • Weight of mothers(Jan 2016 - Dec 2020)
  • Height of mothers(Jan 2016 - Dec 2020)
  • length of infants(Jan 2016 - Dec 2020)
  • Breastfeeding pattern(Jan 2016 - Dec 2020)
  • Body composition of mothers: total body water(Jan 2016 - Dec 2020)
  • Body composition of mothers: fat free mass(Jan 2016 - Dec 2020)
  • Body composition of mothers: fat mass(Jan 2016 - Dec 2020)
  • Weight of infants(Jan 2016 - Dec 2020)
  • Body mass index of mothers(Jan 2016 - Dec 2020)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pattanee Winichagoon

Associate Professor Dr.

Mahidol University

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