To set up this methodology in our Divsion in order to be used in later (international) field studies.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gezondheid van zuigelingen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Average intake of breast milk over a 14-day period.
Secondary outcome
Maternal body composition and energy expenditure.
Background summary
Quantitative assessment of breastmilk intake by infants is usually poor due to
frequent and untimely feeding episodes. The dose-to-mother deuterium oxide
method provides a field tool to assess breastmilk intake quantitatively.
Simultaneously, it provides a method to assess the mother's energy expenditure.
Study objective
To set up this methodology in our Divsion in order to be used in later
(international) field studies.
Study design
Pilot study, observational.
Study burden and risks
Mothers are required to ingest a once-off oral dose of deuterium oxide; this is
neither unpleasant nor associated with any known health risk. Similar studies
have been conducted frequently in lactating women and their babies. Frequent
sample collections (7x) of urine and saliva during a period of 2 weeks may pose
some burden on the subjects.
Bomenweg 2
Wageningen 6703 HD
NL
Bomenweg 2
Wageningen 6703 HD
NL
Listed location countries
Age
Inclusion criteria
Female, apparently healthy
Lactating, either exclusively or partially during the entire study period of 2 weeks
Singleton and apparently healthy baby
Full term pregnancy (>37 weeks)
Exclusion criteria
Participation in other studies
Kidney failure, congestive heart failure
Staying abroad for more than one week during the month preceding the study or planning to travel during the study period
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51043.081.14 |