|- candidate number||12164|
|- NTR Number||NTR3373|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-mrt-2012|
|- Secondary IDs||Nutr-AS-004-2011 FrieslandCampina|
|- Public Title||The effect of Friso Premature on growth, sleep characteristics, Nutritional status parameters and inflammatory markers.|
|- Scientific Title||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.|
|- hypothesis||The addition of a whey protein hydrolysate will improve sleep onset and efficiency and will not limit growth in weight, length and head circumference as compared to the control preterm formula at the age of 10 weeks.|
Because of the alkaline composition, nocturnal acidosis will be significantly lower as compared with the current available preterm formula during the course of the study.
Nutritional status of iron, vitamin A, vitamin D, DHA-AA and folic acid will be more close to normal/required as compared to the current formula at the age of 10 weeks.
Inflammatory and oxidation markers will be lower than in case of the current preterm formula during the course of the study.
|- Healt Condition(s) or Problem(s) studied||Sleep efficiency, Growth, Nutrional status, Inflammatory markers|
|- 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||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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2012|
|- planned closingdate||1-okt-2012|
|- Target number of participants||60|
|- 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.
|- Primary outcome||1. Growth;|
2. Sleep efficiency;
3. Nutritional status of iron, vitamin D, vitamin A, folic acid, and DHA-AA.
|- Secondary outcome||Inflammatory markers in blood and urine.|
|- Timepoints||The intervention period will last for 8 weeks and the several parameters will be studied at the start (age 14±2 days), and at the age of 30±2 days, 45±2 days and 75±2 days. Venous blood samples will only be collected at 14±2 days and 75±2 days.
Methods of measurement:
1. Anthropometry: Body weight, height and head circumference according to standard procedures;
2. Tolerance: Based on 3-days diary;
3. Sleep onset and efficieny: By 3 days Actiwatch monitoring and sleep diary;
4. Metabolic acidification: pH measurement of early morning urine, as well as the analysis of potassium and creatinin in urine;
5. Nutritional status parameters: Vitamin D [25(OH)D], vitamin A [serum retinol & retinol binding protein], iron [Hb, serum ferritin, soluble transferrin receptors], folic acid [serum folate] and total homocysteine according to the standard procedures of the Free University medical center, Amsterdam, The Netherlands. Red blood cell fatty acid composition according to the standard procedure of the University Medical Center Groningen, The Netherlands;
6. Inflammatory status: F2 isoprostanes in early morning urine and c-reactive protein, Interleukin-6 and TNF-alpha in plasma, according to standard procedures of the Free University medical center, Amsterdam, The Netherlands.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Anne Schaafsma|
|- CONTACT for SCIENTIFIC QUERIES|| Anne Schaafsma|
|- Sponsor/Initiator ||Specialized Hospital for Active Treatment of Children’s Disease|
(Source(s) of Monetary or Material Support)
|- Brief summary||In 2010 the ESPGHAN released new recommendations with regard to the composition of formulae for preterm infants. This resulted in quite some discussions about the necessity of some changes. For that reasons it was decided to look for the differences in outcome between the current and ESPGHAN aligned composition. Furthermore, the use of protein hydrolysate should show off in a more tolerable product for preterm infants. |
|- Main changes (audit trail)|
|- RECORD||29-mrt-2012 - 13-apr-2012|