Preterm infants with extremely low birth weight (< 1000 g).
Conditions
Interventions
None.
Sponsors
Danone Research - Centre for Specialised Nutrition
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Growth (gain in body weight, length and head circumference); 2. Gastrointestinal symptoms; 3. Serious Adverse Events (SAEs). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Parameters to assess digestive function in stool; 2. Parameters to assess digestive function in gastric aspirate. | — |
Contacts
Public ContactSandra Helderman-Swart
PO Box 7005
Outcome results
None listed