|- candidate number||14452|
|- NTR Number||NTR3877|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-mrt-2013|
|- Secondary IDs||SPC.1.C/B Danone Research BV|
|- Public Title||Post LaUnch monitoring pretermS.|
|- Scientific Title||Monitoring of tolerance and safety in preterm infants during supplementation
of protein in combination with human milk and/or preterm formula.|
|- hypothesis||Protein Supplement, used for extremely-low-birth-weight (ELBW) infants (< 1000 g) in addition to human milk and/or preterm formula in daily practice, is well tolerated and safe.|
|- Healt Condition(s) or Problem(s) studied||Preterm infants, Low birth weight|
|- Inclusion criteria||1. Birth weight of < 1000 g;|
2. Gestational age s 36 weeks;
3. Decision of the treating medical doctor to start using the Protein Supplement (not applicable for control group);
4. Written informed consent by parent(s)/legal guardian(s) (not applicable
for control group).
|- Exclusion criteria||1. (Anticipated) transfer to another hospital within 2 weeks after start of full enteral feeding;|
2. Major congenital disorders interfering with the protocol requirements as per investigator's clinical judgement;
3. Chromosomal aberrations interfering with the protocol requirements as per investigator's clinical judgement;
4. Systemic metabolic diseases;
5. Participation in any other studies involving investigational or marketed
products interfering with the study conduct, as per investigator's clinical judgement.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||15-mrt-2013|
|- planned closingdate||15-mei-2014|
|- Target number of participants||100|
|- Primary outcome||1. Growth (gain in body weight, length and head circumference);|
2. Gastrointestinal symptoms;
3. Serious Adverse Events (SAEs).
|- Secondary outcome||1. Parameters to assess digestive function in stool;|
2. Parameters to assess digestive function in gastric aspirate.
|- Timepoints||As this is an observational study no interventions will be done on set time points. Infants will follow routine hospital care.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc. Sandra Helderman-Swart|
|- CONTACT for SCIENTIFIC QUERIES||MSc. Sandra Helderman-Swart|
|- Sponsor/Initiator ||Nutricia Research – Centre for Specialised Nutrition|
(Source(s) of Monetary or Material Support)
|Nutricia Research - Centre for Specialised Nutrition |
|- Brief summary||ELBW infants can be recruited into the test group of the study when the use
of the Protein Supplement is indicated by the treating medical doctor. After
informed consent is obtained from the parent(s)/legal guardian(s), ELBW infants follow the standard daily hospital care. Data on growth, tolerance, safety and nutrition is captured as recorded during standard daily practice.
No additional analyses or measurements are performed for the study in the hospital. The study does not intervene with the hospital daily routine.
The control group comes from historical data collected of ELBW infants.|
|- Main changes (audit trail)|
|- RECORD||1-mrt-2013 - 11-mrt-2013|