Growth and Body Composition in Breastfed Infants - Study on Age of Introduction of Complementary Foods in Iceland
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Total body water measured by deuterium oxide
研究概览
简要总结
The purpose of this prospective cohort study is to investigate breast-milk and breastfeeding among infants who are exclusively and partially breastfed at 6 months of age in terms of characteristics that are hypothesised to contribute to growth and development of body composition in infancy.
The scientific originality lies in the simultaneous sampling of multiple factors that are believed to contribute to growth and development of body composition in infancy, i.e. energy content of breast-milk, metabolism-regulating hormones in breast-milk, infant temperament and appetite. The selection of two predefined study groups, i.e. infants exclusively breastfed until 6 months of age and infants given complementary foods in addition to breast-milk from 3-4 months of age, gives the opportunity to describe, and perhaps up to some point compare, what now is described by the World Health Organization and in official Icelandic infant recommendations as "optimal feeding" and what studies have suggested is "common feeding" in many countries. The methods are carefully chosen, i.e. appropriate and non-invasive isotopes and validated questionnaires are used. To our knowledge, no study has reported breast-milk composition in exclusively vs. partially breastfed infants.
详细描述
At approximately 5 months of age, all infants in Iceland are invited to receive routine care (health checkup, immunization etc.) at the well-baby clinics at the primary health care centers in their neighbourhood. Nurses at well-baby clinics in and around Reykjavik cooperating with the study investigators screen all infants for eligibility according the eligibility criteria. Mothers of eligible infants receive oral and written information about the study and if interested, a written consent is obtained and study investigators are informed about the potential participant.
When the infant is around 5.5 months of age, the mother is contacted and a home visit by study investigators scheduled. In the home visit, more detailed information about the study is given and equipment for predose urine samples are given. The date for the first part of the study (day 0) is scheduled.
Day -1 and/or day 0: Mothers sample predose urine sample(s): 2x4 ml for group "Exclusive Breastfeeding A" and 1x2 ml for groups "Exclusive Breastfeeding B" and "Partial Breastfeeding".
Day 0 (home visit by investigators): Infant weighed, drinks 2.5 g/kg body weight + 1 g doubly labeled water or 0.7 g deuterium.
Mothers sample postdose urine samples: 6x4 ml for group "Exclusive Breastfeeding A" (days 1, 2, 3, 5, 6, 7) and 2x2 ml for the other groups (days 0+5 hours and day 2).
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
- 5 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Icelandic mother
- •Singleton birth
- •Gestational age 37-42 weeks
- •Birth weight >2500 g
- •Living in Iceland until 12 months of age
- •Only groups "Exclusive Breastfeeding A" and "Exclusive Breastfeeding B": Exclusively breastfed at 5.5 months of age (≤5 formula feedings and ≤5 water feedings since birth allowed)
- •Only group "Partial Breastfeeding": Receiving at least 100 g / 100 ml of complementary foods (formula or solids) at 5.5 months of age
排除标准
- •Diseases or defects likely to affect growth or body composition
- •Not breastfed at 5.5 months of age
结局指标
主要结局
Total body water measured by deuterium oxide
时间窗: 12 months of age of child
Total body water measured by deuterium oxide and used to determine fat-free mass
次要结局
- Weight measured by infant scales(0-12 months of age of child)
- Length measured by calibrated lengthboards(0-12 months of age of child)
- Metabolisable energy content of breast milk measured using doubly labelled water(5.5 months of age of child)
研究者
Geir Gunnlaugsson
Professor
University of Iceland