- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00298519
Maternal Ethnic Group,Diet,Breast Milk Fatty Acid and Potential Effect Development of Allergy in the Offspring
The Influence of Maternal Ethnic Group and Diet on Breast Milk Fatty Acid Content and Its Potential Effect on Development of Allergy in the Offspring.
연구 개요
상태
정황
상세 설명
Pregnant women with the intention of breastfeeding their babies will be recruited about 36 weeks of gestation. After informed written consent has been obtained, a standard questionnaires will be applied to determine their demographic particulars, family of atopy and environmental details. A trained research coordinator will then profile their diet using a standard validated food frequency questionnaire (FFQ).
After delivery, these mothers will be helped to initiate, establish and continue breastfeeding. Details of their deliveries and the babies' birth measurements will be documented. A breastfeeding diary and infant/child health diary will be given to the mothers to record their breastfeeding practice as well as their child's health status.
The mothers will be followed up in the hospital before discharge, at the postnatal clinic at 1 and 6 weeks, and at 3,6 and 12 months. The mother's blood (1 ml) will be taken at 1 and 6 weeks and breast milk (20 mls) will be collected at 1 week, 6 weeks, 3 months, 6 and 12 months after delivery (as long as mothers breastfeeds).The maternal serum and breast milk total lipids will be extracted and fractionated using micro-extraction and semi-preparative liquid chromatography fraction methods. The fatty acid methyl esters will be separated, using liquid chromatography and capillary electrophoresis coupled mass spectrometry, and tje n-6 and n-3 fatty acid methyl esters identified by comparison with retention times and mass charge ratio information of pure reference substances (sigma Aldrich Sweden AB,Stockholm, Sweden).
The babies of the mothers will be followed up at 1week,6 weeks,3,6,and 12 months of age. At each visit, mothers will answer standard (ISSAC)allergy questionnaires, infant feeding patterns, hygiene practice and child's growth and development parameters: height and weight.At 12 months of age, skin prick testing will performed on the child. This method of detecting atopy is less invasive and gives faster results than measuring serum IgE levels. Our skin prick test protocol follows the routine panel used in NUH's Paediatric Allergy Clinic for under 3 years old viz. Dermatophagoides pteronyssinus (dustmite), Blomia tropicalis (dustmite), cat dander, egg white, soy protein, cow's milk, histamine positive control and saline negative control. Size of wheal and /or erythema when present will be recorded.
The fatty acid analysis of human breast milk have a very low coefficient of variation of about 2% for most of the important fatty acids and therefore 300 mothers and infants will be enough for this pilot study.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Singapore, 싱가포르, 119074
- National University Hospital, Singapore
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Pregnant women of about 36 weeks gestation with the intention of breastfeeding their babies.
Exclusion Criteria:
- Nil
공부 계획
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디자인 세부사항
공동 작업자 및 조사자
수사관
- 수석 연구원: Dr Chong Yap Seng, MBBS, National University Hospital, Singapore
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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마지막으로 확인됨
추가 정보
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