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.
ID
Bron
Verkorte titel
Aandoening
Preterm infants with extremely low birth weight (< 1000 g).
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Growth (gain in body weight, length and head circumference);<br>
2. Gastrointestinal symptoms;<br>
3. Serious Adverse Events (SAEs).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
As this is an observational study no interventions will be done on set time points. Infants will follow routine hospital care.
Onderzoeksproduct en/of interventie
None.
Publiek
Sandra Helderman-Swart
Wageningen 6700 CA
The Netherlands
+31 (0)371 467800
sandra.helderman@danone.nl
Wetenschappelijk
Sandra Helderman-Swart
Wageningen 6700 CA
The Netherlands
+31 (0)371 467800
sandra.helderman@danone.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3714 |
| NTR-old | NTR3877 |
| Ander register | Danone Research BV : SPC.1.C/B |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |