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Effect of Peak Baby Preterm on growth and nutritional status of Nigerian late preterm infants.


- candidate number25650
- NTR NumberNTR6156
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-dec-2016
- Secondary IDs2016-001-GND FrieslandCampina
- Public TitleEffect of Peak Baby Preterm on growth and nutritional status of Nigerian late preterm infants.
- Scientific TitleThe effect of Peak Baby Preterm on growth, and status of DHA, Iron, vitamin D and vitamin A in apparently healthy Nigerian late preterm infants
- ACRONYM
- hypothesisInfants on Peak Baby Premature will have a balanced growth (weight-height) in accordance with what can be considered normal for the target population (based on gestational age) and as shown by the use of specific growth charts and or local intrauterine growth curves, The product will also realize normal concentrations (in accordance with reference values) of DHA, vitamin A, vitamin D and iron in blood or red blood cells. Infants on Peak Premature will at least not increase the number of hospital days as compared to breast milk fed infants.
- Healt Condition(s) or Problem(s) studiedGrowth, Nutrition, Preterm neonates
- Inclusion criteriaapparently healthy, appropriate for gestational age, on full enteral feeding, bottle (at least 50% at inclusion and 100% at age 4 weeks) or breastfed (at least 75% of daily milk intake) dependent on the study groups, being able and willing to drink milk, no medical recognized mental problems.
- Exclusion criteria>50% human milk at inclusion (for the formula group) or >25% formula consumption (for the breastfed group), 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), lactose intolerance, familiar history of impaired iron metabolism (haptoglobin Hp2-2, hemochromatosis, sickelcell anemia, thalassemia). Medications that may effect digestion or absorption of food, medications that may affect sleep, blood transfusions, vitamin supplements during the intervention period.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jan-2017
- planned closingdate1-jun-2018
- Target number of participants60
- InterventionsFormula feeding versus breastfeeding
- Primary outcomeTo determine the effect on growth of a newly developed preterm formula in apparently healthy Nigerian preterm born infants with a gestational age of 32-34 weeks, up to a body weight of 3500 g but at least during a period of 8 weeks.
To determine the effect of the formula on blood status parameters of DHA-AA, vitamins D & A, and iron.
- Secondary outcomeTo get insight in the acceptance of the formula and breast milk by these healthy late preterm infants by using a tolerance questionnaire.
To compare the effects on biochemical nutrient status parameters and growth of the preterm formula with those of breastfed infants.
To get insight in the number of hospital days in both groups (formula and breast milk).
- TimepointsWeekly measurements of growth parameters, blood samples at 14=/- 2 days and 75+/- 2 days for nutritional parameters, tolerance at the start, midway and end of the study.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Anne Schaafsma
- CONTACT for SCIENTIFIC QUERIES Anne Schaafsma
- Sponsor/Initiator College of Medicine University of Ibadan, Department of Pediatrics
- Funding
(Source(s) of Monetary or Material Support)
FrieslandCampina
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD11-dec-2016 - 7-feb-2017


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