At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Growth, Risks of Allergy and Metabolic Syndrome in 6 Year Old Children Born Preterm Compared to Nutrition in the First Four Month After Hospital Discharge
In Brief
A clinical study evaluating Enfamil HM fortifier, Mead Johnson, Enfalac Premature Formula, Mead Johnson Nutritionals, and 1 other intervention for Infant, Very Low Birth Weight and 3 related conditions. Completed, enrolled 239 participants across 1 site.
Detailed Summary
This is a follow-up cohort study of 6 years old children born preterm in Denmark from 2004-2008, and at four different neonatal units. During hospitalisation they received breast milk with fortification. At time of discharge there were made 3 different nutrition groups; if possible they were randomised into one of two groups: 1. Breastfeeding solely 2. Breastfeeding with fortification If breastfeeding was not possible they were put in group 3 and were bottle fed with: 3. Preterm formula This nutrition intervention went on for 4 month. At the age of 6, the children will be invited to come for an ambulant control and other examinations regarding growth, allergy and metabolic syndrome.
Study Details
Timeline
Interventions
Enfamil was added to a small amount of mothers expressed milk and given in a bottle or with a small cup every day. Group 2 (HMF) received 5 packets each day for 4 month containing; 17.5 kcal, 1.375 g protein/ 5 packets
Group 3 received Enfalac containing: 68 kcal, 2 g protein, 7.4 g carbohydrate, 3.5 g fat/ 100 ml
Group 1 received mothers own milk without fortification