- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
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Singapore, Singapur, 119074
- National University Hospital, Singapore
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Pregnant women of about 36 weeks gestation with the intention of breastfeeding their babies.
Exclusion Criteria:
- Nil
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Dr Chong Yap Seng, MBBS, National University Hospital, Singapore
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RPR/NHG/03025
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