Allergy Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 239 |
Est. completion date | June 2016 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 8 Years |
Eligibility |
Inclusion Criteria: - Participated in the original study when they were discharge from hospital - Parents accept of participation in the 6 year follow-up Exclusion Criteria: - Participation not accepted by parents - Genetic diseases with influence on growth |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | HC Anderson Children´s Hospital, OUH | Odense |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark | Aarhus University Hospital, Holbaek Sygehus, Kolding Sygehus |
Denmark,
Amesz EM, Schaafsma A, Cranendonk A, Lafeber HN. Optimal growth and lower fat mass in preterm infants fed a protein-enriched postdischarge formula. J Pediatr Gastroenterol Nutr. 2010 Feb;50(2):200-7. doi: 10.1097/MPG.0b013e3181a8150d. — View Citation
Barker DJ. In utero programming of chronic disease. Clin Sci (Lond). 1998 Aug;95(2):115-28. — View Citation
De Curtis M, Pieltain C, Rigo J. Body composition in preterm infants fed standard term or enriched formula after hospital discharge. Eur J Nutr. 2002 Aug;41(4):177-82. — View Citation
Farooqi A, Hägglöf B, Sedin G, Gothefors L, Serenius F. Growth in 10- to 12-year-old children born at 23 to 25 weeks' gestation in the 1990s: a Swedish national prospective follow-up study. Pediatrics. 2006 Nov;118(5):e1452-65. — View Citation
G. Zachariassen, J Færk mf. Nutrient-enrichment of human milk for preterm infants after hospital discharge - a randomized controlled trial. Pediatrics 2010.
Hack M, Schluchter M, Cartar L, Rahman M, Cuttler L, Borawski E. Growth of very low birth weight infants to age 20 years. Pediatrics. 2003 Jul;112(1 Pt 1):e30-8. — View Citation
Hofman PL, Regan F, Harris M, Robinson E, Jackson W, Cutfield WS. The metabolic consequences of prematurity. Growth Horm IGF Res. 2004 Jun;14 Suppl A:S136-9. Review. — View Citation
Hofman PL, Regan F, Jackson WE, Jefferies C, Knight DB, Robinson EM, Cutfield WS. Premature birth and later insulin resistance. N Engl J Med. 2004 Nov 18;351(21):2179-86. Erratum in: N Engl J Med. 2004 Dec 30;351(27):2888. — View Citation
Liem JJ, Kozyrskyj AL, Huq SI, Becker AB. The risk of developing food allergy in premature or low-birth-weight children. J Allergy Clin Immunol. 2007 May;119(5):1203-9. Epub 2007 Mar 26. — View Citation
O'Connor DL, Khan S, Weishuhn K, Vaughan J, Jefferies A, Campbell DM, Asztalos E, Feldman M, Rovet J, Westall C, Whyte H; Postdischarge Feeding Study Group. Growth and nutrient intakes of human milk-fed preterm infants provided with extra energy and nutrients after hospital discharge. Pediatrics. 2008 Apr;121(4):766-76. doi: 10.1542/peds.2007-0054. — View Citation
Siltanen M, Savilahti E, Pohjavuori M, Kajosaari M. Respiratory symptoms and lung function in relation to atopy in children born preterm. Pediatr Pulmonol. 2004 Jan;37(1):43-9. — View Citation
Zachariassen G, Faerk J, Esberg BH, Fenger-Gron J, Mortensen S, Christesen HT, Halken S. Allergic diseases among very preterm infants according to nutrition after hospital discharge. Pediatr Allergy Immunol. 2011 Aug;22(5):515-20. doi: 10.1111/j.1399-3038.2010.01102.x. Epub 2011 Feb 20. — View Citation
Zachariassen G, Faerk J, Grytter C, Esberg BH, Hjelmborg J, Mortensen S, Thybo Christesen H, Halken S. Nutrient enrichment of mother's milk and growth of very preterm infants after hospital discharge. Pediatrics. 2011 Apr;127(4):e995-e1003. doi: 10.1542/peds.2010-0723. Epub 2011 Mar 14. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Allergy | Test for lung function: body box breathing test | Follow-up at approximately 6 years corrected age | No |
Other | Growth | Lenght at 6 years corrected age | Follow-up at approximately 6 years corrected age | No |
Other | Growth | Head circumference at 6 years corrected age | Follow-up at approximately 6 years corrected age | No |
Other | Metabolic syndrome | Blood test; blood glucose, HbA1c, HDL, insulin, Insulin-like growth factor 1 (IgF1), C-peptide | Follow-up at approximately 6 years corrected age | No |
Other | Metabolic syndrome | Blood pressure | Follow-up at approximately 6 years corrected age | No |
Other | Allergy | Allergy questionnaire | Follow-up at approximately 6 years corrected age | No |
Other | Allergy | blood samples; Immunoglobulin E (IgE) | Follow-up at approximately 6 years corrected age | No |
Other | Allergy | Lung function: NO-test | Follow-up at approximately 6 years corrected age | No |
Primary | Growth | Measurement of weight at 6 years corrected age | Follow-up at approximately 6 years corrected age | No |
Secondary | Metabolic syndrome | Dexa scan including fat mass, muscle mass, bone mass and Body Mass Index. | Follow-up at approximately 6 years corrected age | No |
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