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The effect of Friso Premature on growth, sleep characteristics, Nutritional status parameters and inflammatory markers.

The effect of Friso Premature on growth, sleep characteristics, Nutritional status parameters (DHA, Iron, vitamin D, vitamin A and folic acid), inflammatory markers, and F2-isoprostanes in urine.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25053
Enrollment
60
Registered
2012-03-29
Start date
2012-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep efficiency, growth, nutritional status, inflammatory markers. Slaap efficientie, groei, voedingskundige status, ontstekings indicatoren.

Interventions

A. Current formulae for preterm infants during the hospital phase (till 3500 g of body weight)
B. Preterm formulae with protein hydrolysate, and increased levels of some vitamins and minerals in accordance with the ESPGHAN guidelines.

Sponsors

Specialized Hospital for Active Treatment of Children’s Disease, Sofia, Bulgaria
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Apparently healthy infants, appropriate for gestational age (AGA); 2. Gestational age of 32 up to but not including 35 (ongoing) weeks; 3. Full enteral nutrition; 4. Not younger than 2 or older than 3 weeks of age at inclusion; 5. Bottle fed; 6. Being able and willing to drink milk; 7. No medical recognized mental problems.

Exclusion criteria

Exclusion criteria: 1. Human milk consumption; 2. Congenital malformations or conditions known to affect growth (e.g. severe broncho pulmonary dysplasia, inborn error of metabolism, cardiac or renal disease, necrotizing enterocolitis with substantial gut loss, and grade IV intraventricular hemorrhage); 3. Lactose intolerance; 4. Familiar history of impaired iron metabolism (haptoglobin Hp2-2, hemochromatosis, sickelcell anemia, thalassemia); 5. Medications that may effect digestion or absorption of food, or affect sleep; 6. Blood transfusions; 7. Vitamin supplements during the intervention period.

Design outcomes

Secondary

MeasureTime frame
Inflammatory markers in blood and urine.

Primary

MeasureTime frame
1. Growth; 2. Sleep efficiency; 3. Nutritional status of iron, vitamin D, vitamin A, folic acid, and DHA-AA.

Contacts

Public ContactAnne Schaafsma

P.O.Box 226

anne.schaafsma@frieslandcampina.com+31 (0)58 2992424

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)