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Post LaUnch monitoring pretermS.


- candidate number14452
- NTR NumberNTR3877
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-mrt-2013
- Secondary IDsSPC.1.C/B  Danone Research BV
- Public TitlePost LaUnch monitoring pretermS.
- Scientific TitleMonitoring of tolerance and safety in preterm infants during supplementation of protein in combination with human milk and/or preterm formula.
- ACRONYMPLUS
- hypothesisProtein 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) studiedPreterm infants, Low birth weight
- Inclusion criteria1. 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 criteria1. (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 receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 15-mrt-2013
- planned closingdate15-mei-2014
- Target number of participants100
- InterventionsNone.
- Primary outcome1. Growth (gain in body weight, length and head circumference);
2. Gastrointestinal symptoms;
3. Serious Adverse Events (SAEs).
- Secondary outcome1. Parameters to assess digestive function in stool;
2. Parameters to assess digestive function in gastric aspirate.
- TimepointsAs this is an observational study no interventions will be done on set time points. Infants will follow routine hospital care.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc. Sandra Helderman-Swart
- CONTACT for SCIENTIFIC QUERIESMSc. Sandra Helderman-Swart
- Sponsor/Initiator Nutricia Research Centre for Specialised Nutrition
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition
- PublicationsNo
- Brief summaryELBW 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)
- RECORD1-mrt-2013 - 11-mrt-2013


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