An observational study to characterize human milk of mothers delivering term SGA and AGA infants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 4
- 主要终点
- 1.Milk samples will be collected longitudinally from the mothers will be enrolled for the characterization by modern analytical and state-of-the-art techniques.
研究概览
简要总结
Thisis an observational study to characterize human milk of mothers delivering termSGA and term AGA infants. This is an observational, exploratory, longitudinal(from birth to 6 months postpartum), 4 parallel groups, and multi-centricstudy. Total of max 260 subjects will be randomized in the study assuming 20% dropout rate. The recruitment period for the study in India is for 6 months.
The Primary Objective of the study is to characterize and quantify maternal milk composition from mothers of adequately nourished and under nourished status delivering term Small for Gestational Age (SGA) infants, compared to adequately-nourished and undernourished mothers delivering term Appropriate for Gestational Age (AGA) infants as defined in Intergrowth-21st Newborn Size Chart
The secondary objective of the study is-
1. Association of maternal milk components with dietary intake and nourishment status of the mother.
2. Associations of maternal and infant clinical parameters to maternal milk nutrients.
To explore and analyze additional functional milk components, such as triacylglycerol, cholesterols, carotenoids, vitamins, microbiota, peptide profile, microRNA, cytokines, growth factors and hormones.
| The subject will enroll in the study after signing the Informed Consent Form after delivery the infants (i.e. term AGA & term SGA) within 72 hours. Total Duration of the study for subject is 24 weeks. Sponsor will notify the end of study after 90 days of last subject last visit. Principal Investigator responsibility is to detect and document AE and SAE. |
Reference:
| 1. Agostoni C. Small-for-gestational-age infants need dietary quality more than quantity for their development: the role of human milk. Acta Paediatr. 2005 Jul;94(7):827-9. |
- Barker DJP, Winter PD, Osmond C, Margetts B, Simmonds SJ. Weight in infancy and death from ischemic heart disease. Lancet 1989;2:577–80.
| 3. Barker DJP, Hales CN, Fall CHD, Osmond C, Phipps K, Clark PMS. Type 2 (non-insulin-dependent) diabetes mellitus, hypertension and hyperlipidemia (syndrome X): relation to fetal growth. Diabetologia 1993;36:62–7. |
4. Figueras F, Oros D, Cruz-Martinez R, Padilla N, Hernandez-Andrade E, Botet F, Costas-Moragas C, Gratacos E. Neurobehavior in term, small-for-gestational age infants with normal placental function. Pediatrics. 2009 Nov;124(5):e934-41. doi: 10.1542/peds.2008-3346.
5. Karlberg J, Albertsson-Wikland K. Growth in full-term small-forgestational-age infants: from birth to final length. Pediatr Res 1995;38:733–9.
6. Lee AC, Katz J, Blencowe H, et al. for the CHERG SGA-Preterm Birth Working Group. National and regional estimates of term and preterm babies born small for gestational age in 138 low-income and middle-income countries in 2010. Lancet Glob Health 2013; 1: e26-e36.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.All mothers who delivered term infants, either SGA or AGA 2.Mothers between 18 and 40 years of age inclusive, at the time of enrolment 3.Having decided to predominantly breast-feed their new born baby at least until 6 months of age 4.Having permanent residence at a maximum distance of 50km from the hospital/center of investigation for the duration of this study and being able to follow all the steps of this study 5.Willing to provide informed consent according to the requirements of local regulations.
排除标准
- •1.Preterm delivery (≤ 36 weeks + 6 days completed) of gestational age) 2.Currently participating or having participated in an interventional clinical trial during the last 4 weeks prior to the beginning of this study 3.Having a BMI ≥ 25.0 4.Chewing tobacco, smoking or drinking alcohol (> 1 glass per day), consuming illicit drugs during pregnancy or/and duration of the study 5.Presenting any disease or medical condition which might prevent breast-feeding or collecting the human milk samples or for which breast-feeding is contraindicated 6.Having diabetes or gestational diabetes mellitus 7.Presenting dietary problems/illnesses such as anorexia, bulimia and celiac disease 8.Subject unable to comply with study procedures or unable to come to hospital for the study visits.
结局指标
主要结局
1.Milk samples will be collected longitudinally from the mothers will be enrolled for the characterization by modern analytical and state-of-the-art techniques.
时间窗: Throughout the study period.
2. Analyses of functional milk components, such as macronutrients (total fat, total protein, total lactose, total energy and total solid, crude proteins) and total protein analysis by BCA kit is planned.
时间窗: Throughout the study period.
次要结局
- 1.Dietary intake will be assessed by a dietary questionnaire and analyzed by tool/books.(Example-By use of “Nutritive Value of Indian Foods†or a similar book/tool issued by National Institute of Nutrition)
- 2.The maternal milk composition will be correlated longitudinally to mother’s diet, stage of lactation, type of delivery, sex of the infant, single/multiple birth, infant anthropometric measures (weight, length and head circumference), gestational age at birth and birth anthropometrics(Throughout the study period.)
- 3. Other parameters & functional milk components are considered as exploratory. Inclusion of these & other possible exploratory parameters will be assessed periodically or at end of study based on development of these analytical methodologies in India .(Throughout the study period.)