Effect of Peak Baby Preterm on growth and nutritional status of Nigerian late preterm infants.
- Conditions
- Growth, nutritional status, apparently healthy late preterm infants, Nigeria, DHA, Iron, Vitamin A, Vitamin D
- Registration Number
- NL-OMON21985
- Lead Sponsor
- Department of Pediatrics, College of Medicine University of Ibadan, Ibadan, Nigeria
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
apparently 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.
>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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To 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. <br /><br>To determine the effect of the formula on blood status parameters of DHA-AA, vitamins D & A, and iron.<br>
- Secondary Outcome Measures
Name Time Method To get insight in the acceptance of the formula and breast milk by these healthy late preterm infants by using a tolerance questionnaire.<br /><br>To compare the effects on biochemical nutrient status parameters and growth of the preterm formula with those of breastfed infants. <br /><br>To get insight in the number of hospital days in both groups (formula and breast milk).<br>