|- candidate number||18337|
|- NTR Number||NTR4685|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jul-2014|
|- Secondary IDs||ABR48368 |
|- Public Title||Test weighing: determining precision using a ‘double-check weighing’ method|
|- Scientific Title||Test weighing: determining precision using a ‘double-check weighing’ method|
|- hypothesis||Test weighing using a double-check weighing method is precise in determining infant intake: in more than 90% of weighings test weighing will be within 5ml of the actual amount drunk|
|- Healt Condition(s) or Problem(s) studied||Breastfeeding , Food intake|
|- Inclusion criteria||-Admission in the neonatal ward. |
-Bottle or fully nasogastric fed infants
|- Exclusion criteria||-If the treating pediatrician finds the infant to be too unstable for the extra weighing.|
-If, according tot the treating pediatrician, the infant requires minimal handling.
-If the parents of caregivers speak insufficient Dutch to be able to give informed consent
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||5-jan-2014|
|- planned closingdate||5-jun-2014|
|- Target number of participants||40|
|- Primary outcome||precision of test weighing, using a double-check weighing method for 2 scales in 2 groups: intake up to 20cc and 20cc and more|
|- Secondary outcome||-Accuracy of test weighing, using a double-check weighing method for 2 scales in 2 groups: intake up to 20cc and 20cc and more. |
-accuracy and precision including and excluding infants with monitor leads or intravenous lines
-Accuracy and precision including and excluding infants who vomited, or where milk was spilled.
-The influence of the childs state on accuracy and precision of test weighing.
-The influence of the pre feed weight on the precision of test weighing.
-The influence of the intake as a continuous variable on the precision of test weighing.
|- Timepoints||not applicable.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| G.J. Jaspers|
|- CONTACT for SCIENTIFIC QUERIES|| G.J. Jaspers|
|- Sponsor/Initiator ||VieCuri Medisch Centrum voor Noord-Limburg|
(Source(s) of Monetary or Material Support)
|VieCuri Medisch Centrum voor Noord-Limburg|
|- Publications||Haase, B., et al., The development of an accurate test weighing technique for preterm and high-risk hospitalized infants. Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine, 2009. 4(3): p. 151-6.|
Savenije, O.E. and P.L. Brand, Accuracy and precision of test weighing to assess milk intake in newborn infants. Archives of disease in childhood. Fetal and neonatal edition, 2006. 91(5): p. F330-2
|- Brief summary||Rationale: test weighing is used extensively to assess intake in breastfed infants. Data regarding its precision however differ and are contradictory. There is discussion about the technique and scales used. Our goal is to use a double check weighing procedure on 2 different scales and determine precision in a large group of newborn infants.|
Objective: to determine the precision of test weighing on 2 different scales in 2 different intake groups: feeds up to 20 cc and feeds of 20cc and more.
Study design: diagnostic accuracy study in a cohort of newborn infants.
Study population: All exclusively bottle or nasogastric fed infants in the neonatal ward are deemed eligible.
Intervention: infants are weighed twice before and twice after a feed in a standardized way by an independent investigator, unaware of the amount drunk. The weights before, as well as the weights after feeding, have to be within 5 grams. Otherwise a third weight has to be obtained. The difference between the averaged weights before and the averaged weights after feeding is taken to reflect intake in cc. The actual amount drunk will be determined by weighing the bottles before and after feeding.
Main study parameters/endpoints: precision will be calculated by determining the standard deviation of the mean of the difference between the test weighing amount and actual amount drunk.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Risks are negligible. Weighing is a routine procedure done in all neonatal wards. Weighing will be done in infants who are about to be fed, so it will not interfere with sleep or resting.
|- Main changes (audit trail)|
|- RECORD||11-jul-2014 - 11-aug-2014|