This study aims to assess the degree of accuracy of test weighing in order to determine whether or not test weighing is a useful method in clinical practice.
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this study is the degree of accuracy of the weighing
result set against the actual milk intake.
Secondary outcome
Will devices, which are connected to the neonate during test weighing (monitor
wires, pulse oximeter, infusion lines), affect the accuracy of the test
weighing?
Background summary
Weighing before and after breastfeeding (test weighing) is a commonly used
method to estimate milk intake in neonates. There is, however, no consensus on
the reliability of this method of test weighing. Questioning the reliability of
test weighing has major consequences for the guidance of women breastfeeding
sick or premature neonates, since there are no other clinically useful methods
to estimate breastmilk intake.
Study objective
This study aims to assess the degree of accuracy of test weighing in order to
determine whether or not test weighing is a useful method in clinical practice.
Study design
This study is an observational study.
Neonates who are being fed by bottle, are swaddled en weighed before and
immediately after regular feeding by a blinded investigator. The initial body
weight of the neonate, measured right before feeding, is subtracted from the
body weight of the infant after feeding. This calculation provides an estimate
of the milk intake of the neonate.
The actual amount of milk (in milligrams) drunk by the neonate, is measured
consecutively. For this purpose, the milk bottle is weighed before feeding
(measurement 1), and immediately after feeding the same bottle with the rest of
the milk is weighed again (measurement 2).
The result of measurement 2 is subtracted from the result of measurement 1.This
calculation indicates the actual amount of milk consumed in milligrams. For
this measurement, it is assumed that 1 milligram of milk equals1 milliliter of
milk.
Weighing takes place according to a standardized validated weighing method.
Before weighing the neonates, the scales, which are digital medical class III
baby scales, are calibrated according to the Dutch Metrology Act. The accuracy
of the scales is assessed by means of calibration; meaning in this case
determining the standard deviation of repeated measurements with standard
weights.
Study burden and risks
The risks associated with participation in the study may reasonably be regarded
as negligible.
The neonate is weighed in the room where it is resides during hospitalization
and the mobile baby scales are brought to the neonate. The neonate is weighed
as it is, additional dressing or undressing is not required. The infant is
placed on the scales for weighing twice: before and after feeding.
The weighing takes about 1 to 2 minutes per weighing, thus in total about 4
minutes. Each neonate can participate once in the study.
Prins Constantijnweg 2
Capelle aan den IJssel 2906 ZC
NL
Prins Constantijnweg 2
Capelle aan den IJssel 2906 ZC
NL
Listed location countries
Age
Inclusion criteria
Infants, admitted to the neonatal ward of the IJsselland Hospital, a general hospital in the Netherlands.
The infants meet the following criteria: postconceptional age on day of study between 34 and 44 weeks, with or without feeding tube, iv drip and infusion splint, monitor lead wires.
The infants are bottle fed mothermilk or formula with volumes at least 10 ml
Exclusion criteria
Clinically unstable neonates, assessment of clinical stability by the attending pediatrician.
Neonates who required continuous connection to monitors
Neonates who are not able to drink from bottle
Exclusively breastfed neonates
Design
Recruitment
metc-ldd@lumc.nl
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 | NL45687.098.13 |