Establishing Global Reference Values for Human Milk
Açar sözlər
Mücərrəd
Təsvir
The investigators will collect breast milk samples at four visits, at 2-3 days after birth (colostrum) and at 1-3.4, 3.5-5.9, and 6-8.5 months of lactation from well-nourished mothers age ≥18 to ≤40 years, in a systematic, identical way in four countries. The four sites are: Copenhagen, Denmark; Banjul, The Gambia; Rio de Janeiro, Brazil; and Mirpur, Dhaka, Bangladesh. The most important site selection criteria were that multiple micronutrient supplements are not consumed after week 28 of pregnancy; maternal diet is adequate but consumption of highly fortified foods is limited; and exclusive breastfeeding is 60% at 4 months.
In order to have 250 women and infants per site complete the study at 8.5 months, approximately 500 women will be recruited during the third trimester of pregnancy. This should allow for mothers and infants not meeting study eligibility criteria in pregnancy or early lactation, and drop-outs from the study. Recruitment during pregnancy will increase the opportunity to locate and recruit women since recruitment in the immediate post-delivery period will be difficult. It will also enable the women to be counselled on the importance of exclusive breastfeeding (EBF). Colostrum will be collected at 2-3 days postpartum for future analysis. The first collection of mature milk will occur between 1 and 3.4 months postpartum, when maternal and infant blood samples will also be collected on all participants. At the final two visits, in addition to milk collection, blood will be taken from all mothers but only half of the infants each time, primarily for the assessment of micronutrient status.
A requirement is that infants must be EBF in the 1-3.4 month period, and breastfed (BF) in the second and third period. Longitudinal measurements on the same mother after the BF period are not necessary for statistical reasons, as the investigators are not creating RVs for change in milk composition. The investigators expect that due to attrition and cessation of BF, the sample size will need to be augmented in later months; the alternative would have been to recruit and measure many more women in earlier stages in order to have an adequate sample size in the 7-8.5 month interval, which would be a much less efficient approach. Therefore after 6 months, if women are not breastfeeding, additional lactating women will be recruited from the group that was not EBF in the 3.4 month period, or from the local health center or community.
At all three points of mature milk collection the investigators will measure breast milk volume; diet, anthropometry and morbidity of the mother and infant; and infant development at 3.5-5.9 and 6 to 8.5 months; and will collect infant fecal samples for future analyses of the microbiome. Milk volume will be measured at three sites using the International Atomic Energy Agency's protocol that requires dosing the mother with deuterated water and collecting maternal and infant saliva urine samples at 0, 1, 2, 3, 4, 13 and 14 days after the dose. In Denmark breast milk volume will be measured by 24 hour infant weighing.
Most of the laboratory analyses will be conducted at the United States Department of Agriculture, Agricultural Research Service, Western Human Nutrition Research Center (WHNRC) in Davis, California. Other analyses will be performed in the Department of Chemistry at University of California, Davis (HMOs and other bioactive compounds in milk), and the Swiss Federal Institute of Technology in Zurich (iodine status). RVs will be constructed following the methods and principles developed for the World Health Organization (WHO) Child Growth Standards and the Intergrowth-21st Project.
An add-on study "Evaluation of maternal insulin resistance, metabolic and inflammatory biomarkers for prediction of successful initiation and duration of breastfeeding" is being conducted at the Danish site and was approved by The Regional Committee on Health Research Ethics with (H-17015174).
The aims of the add-on study are to evaluate if maternal metabolic and inflammatory biomarkers can predict successful initiation and duration of breastfeeding in a population of healthy non-obese Danish women, to evaluate the impact of maternal inflammatory biomarkers during pregnancy on the offspring's growth and risk factors for later disease, and to relate the impact of maternal metabolic and inflammatory biomarkers during pregnancy on breastfeeding behavior and on the offspring's growth and risk factors for later disease in this population to corresponding outcomes in an established cohort of infants born of obese mothers.
Tarixlər
Son Doğrulandı: | 02/29/2020 |
İlk təqdim: | 08/02/2017 |
Təxmini qeydiyyat təqdim edildi: | 08/14/2017 |
İlk Göndərmə: | 08/17/2017 |
Son Yeniləmə Göndərildi: | 03/01/2020 |
Son Yeniləmə Göndərildi: | 03/03/2020 |
Həqiqi Təhsilin Başlama Tarixi: | 08/31/2017 |
Təxmini İlkin Tamamlanma Tarixi: | 12/30/2020 |
Təxmini İşin Tamamlanma Tarixi: | 11/29/2021 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Other: Assessment of human milk nutrient composition
Faza
Qol Qrupları
Qol | Müdaxilə / müalicə |
---|---|
Bangladesh Assessment of human milk nutrient composition. Approximately 500 women and their infants recruited, 250 dyads completing study | |
Brazil Assessment of human milk nutrient composition. Approximately 500 women and their infants recruited, 250 dyads completing study | |
Denmark Assessment of human milk nutrient composition. Approximately 500 women and their infants recruited, 250 dyads completing study | |
The Gambia Assessment of human milk nutrient composition. Approximately 500 women and their infants recruited, 250 dyads completing study |
Uyğunluq Kriteriyaları
Təhsil üçün uyğun yaşlar | 18 Years Üçün 18 Years |
Təhsilə Uyğun Cinslər | Female |
Nümunə götürmə metodu | Non-Probability Sample |
Sağlam Könüllüləri qəbul edir | Bəli |
Kriteriyalar | Inclusion Criteria for Mother - No vitamin-mineral supplements during third trimester of pregnancy or during lactation except for iron + folic acid, also vitamin D and Ca in Denmark. - Low habitual intake of highly-fortified foods (iodized salt excepted). - No relevant past or current medical problems including gestational diabetes or pre-eclampsia. - Singleton delivery, not preterm. - BMI ≥18.5 to <30.0 kg/m2, height ≥150 cm. - Mid-upper arm circumference (MUAC) ≥23 and ≤33 cm in pregnancy - Consuming a nutritionally adequate diet i.e. not vegan or macrobiotic, ≥5 food groups/d each ≥15g. At screening this information will be collected with a locally-appropriate and validated food frequency questionnaire. - Non-anemic in pregnancy (Hb >100 g/L) - Alcohol intake ≤5 units (50 mL pure alcohol)/week. - Non-smoker. Inclusion Criteria for Infant - Birth weight 2500-4200 g, 37-42 weeks of gestation. - No congenital malformations that interfere with feeding or growth and development. Exclusion Criteria at 1 to 3.4 Months Postpartum - Cessation of or non-exclusive breastfeeding. - Serious maternal illness. - Infant length-for-age, weight-for-age or weight-for-length < -2 Z. Exclusion criteria 3.5 to 8.5 months postpartum - Cessation of breastfeeding. - Serious maternal illness. - Infant length-for-age, weight-for-age or weight-for-length < -2 Z. |
Nəticə
İlkin nəticə tədbirləri
1. Change in vitamin and mineral concentrations in human breast milk [Breast milk samples collected 1-3.4, 3.5-5.9, and 6-8.5 months postpartum]
İkincili Nəticə Tədbirləri
1. Variation in other constituents of human breast milk [Breast milk samples collected at 1-3.4, 3.5-5.9, and 6-8.5 months postpartum]
2. Micronutrient status of mothers and infants [Blood and urine samples surveyed at 1-3.4, 3.5-5.9, and 6-8.5 months postpartum]
3. Milk volume [1-3.4, 3.5-5.9, and 6-8.5 months postpartum]
4. Maternal and infant iodine status [1-3.4, 3.5-5.9, and 6-8.5 months postpartum]
5. Milk iodine [1-3.4, 3.5-5.9, and 6-8.5 months postpartum]
6. Maternal nutrient intake during pregnancy [Measured during gestational week 35-37]
7. Maternal nutrient intake [1-3.4, 3.5-5.9, and 6-8.5 months postpartum]
8. Infant nutrient intake [1-3.4, 3.5-5.9, and 6-8.5 months]
9. Infant dietary habits [1-3.4, 3.5-5.9, and 6-8.5 months]
10. Maternal weight [1-3.4, 3.5-5.9, and 6-8.5 months postpartum]
11. Infant weight [1-3.4, 3.5-5.9, and 6-8.5 months]
12. Maternal height [1-3.4, 3.5-5.9, and 6-8.5 months postpartum]
13. Infant length [1-3.4, 3.5-5.9, and 6-8.5 months]
14. Maternal body mass index [1-3.4, 3.5-5.9, and 6-8.5 months postpartum]
15. Infant growth [1-3.4, 3.5-5.9, and 6-8.5 months postpartum]
16. Maternal body composition [1-3.4, 3.5-5.9, and 6-8.5 months postpartum]
17. Infant body composition [1-3.4, 3.5-5.9, and 6-8.5 months]
18. Infant morbidity [1-3.4, 3.5-5.9, and 6-8.5 months]
19. Infant development [6-8.5 months]
20. Infant motor development [3.5-5.9 and 6-8.5 months]
21. Change in infant microbiome [1-3.4, 3.5-5.9, and 6-8.5 months]
22. Change in maternal microbiome [Collected at gestational week 28-40, and 1-3.4, 3.5-5.9, and 6-8.5 months postpartum]
23. Maternal Glucose Tolerance [Measured once at gestational week 28-30]
24. Maternal Hemoglobin A1c (HbA1c) [Measured once at gestational week 28-30]
25. Maternal markers of insulin sensitivity [Measured once at gestational week 28-30]
26. Maternal lipid panel [Measured once at gestational week 28-30]
27. Maternal inflammatory markers [Measured once at gestational week 28-30]