Growth, Risks of Allergy and Metabolic Syndrome in 6 Year Old Children Born Preterm Compared to Postdischarge Nutrition

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.

Conditions

• Infant, Very Low Birth Weight
• Metabolic Syndrome, Protection Against
• Allergy
• Dietary Modification

Interventions

DIETARY_SUPPLEMENT

Enfamil HM fortifier, Mead Johnson

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

DIETARY_SUPPLEMENT

Enfalac Premature Formula, Mead Johnson Nutritionals

Group 3 received Enfalac containing: 68 kcal, 2 g protein, 7.4 g carbohydrate, 3.5 g fat/ 100 ml

DIETARY_SUPPLEMENT

Mothers own milk

Group 1 received mothers own milk without fortification

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Holbaek Sygehus

  collaborator OTHER

• Kolding Sygehus

  collaborator OTHER

• University of Southern Denmark

  lead OTHER

Principal Investigators

• Gitte Zachariassen, Specialist · HC Anderson Children´s Hospital, OUH, Denmark

• Susanne Halken, Professor · HC Anderson children´s Hospital, OUH, Denmark

• Lone Agertoft, Specialist · HC Anderson children´s Hospital, OUH, Denmark

• Line H Toftlund, MD · HC Anderson children´s Hospital, OUH, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

8 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2015-04-30

Completion

2016-06-30

Countries

• Denmark

Study Locations