Growth, Risks of Allergy and Metabolic Syndrome in 6 Year Old Children Born Preterm Compared to Postdischarge Nutrition
1 other identifier
interventional
239
1 country
1
Brief 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
- 3.Preterm formula
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 28, 2014
CompletedFirst Posted
Study publicly available on registry
March 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedOctober 27, 2016
October 1, 2016
4.5 years
February 28, 2014
October 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Growth
Measurement of weight at 6 years corrected age
Follow-up at approximately 6 years corrected age
Secondary Outcomes (1)
Metabolic syndrome
Follow-up at approximately 6 years corrected age
Other Outcomes (8)
Allergy
Follow-up at approximately 6 years corrected age
Growth
Follow-up at approximately 6 years corrected age
Growth
Follow-up at approximately 6 years corrected age
- +5 more other outcomes
Study Arms (3)
Group 1, HM
ACTIVE COMPARATORThis group received breastfeeding (human milk, HM) solely throughout the 4 month of intervention. Randomisation for group 1 or group 2. Mothers own milk.
Group 2, HMF
ACTIVE COMPARATORThis group received mothers own milk with fortification (human milk fortification, HMF) throughout the 4 month intervention period. Randomisation for group 1 og group 2. Enfamil HM fortifier, Mead Johnson.
Group 3, PF
ACTIVE COMPARATORThis group received preterm formula (PF) throughout the intervention period of 4 month. This group was not randomised for ethical reasons. Enfalac Premature Formula, Mead Johnson Nutritionals
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
Eligibility Criteria
You may qualify if:
- Participated in the original study when they were discharge from hospital
- Parents accept of participation in the 6 year follow-up
You may not qualify if:
- Participation not accepted by parents
- Genetic diseases with influence on growth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Denmarklead
- Aarhus University Hospitalcollaborator
- Holbaek Sygehuscollaborator
- Kolding Sygehuscollaborator
Study Sites (1)
HC Anderson Children´s Hospital, OUH
Odense, 5000, Denmark
Related Publications (14)
Barker DJ. In utero programming of chronic disease. Clin Sci (Lond). 1998 Aug;95(2):115-28.
PMID: 9680492BACKGROUNDHofman 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. doi: 10.1016/j.ghir.2004.03.029.
PMID: 15135796BACKGROUNDAmesz 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.
PMID: 19881394BACKGROUNDHofman 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. doi: 10.1056/NEJMoa042275.
PMID: 15548778BACKGROUNDSiltanen 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. doi: 10.1002/ppul.10402.
PMID: 14679488BACKGROUNDLiem 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. doi: 10.1016/j.jaci.2006.12.671. Epub 2007 Mar 26.
PMID: 17379288BACKGROUNDG. Zachariassen, J Færk mf. Nutrient-enrichment of human milk for preterm infants after hospital discharge - a randomized controlled trial. Pediatrics 2010.
BACKGROUNDO'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.
PMID: 18381542BACKGROUNDHack 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. doi: 10.1542/peds.112.1.e30.
PMID: 12837903BACKGROUNDFarooqi A, Hagglof 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. doi: 10.1542/peds.2006-1069.
PMID: 17079546BACKGROUNDDe 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. doi: 10.1007/s00394-002-0374-2.
PMID: 12242586BACKGROUNDZachariassen 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.
PMID: 21402642BACKGROUNDZachariassen 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.
PMID: 21332800BACKGROUNDToftlund LH, Halken S, Agertoft L, Zachariassen G. Early nutrition and signs of metabolic syndrome at 6 y of age in children born very preterm. Am J Clin Nutr. 2018 May 1;107(5):717-724. doi: 10.1093/ajcn/nqy015.
PMID: 29722837DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gitte Zachariassen, Specialist
HC Anderson Children´s Hospital, OUH, Denmark
- STUDY CHAIR
Susanne Halken, Professor
HC Anderson children´s Hospital, OUH, Denmark
- STUDY DIRECTOR
Lone Agertoft, Specialist
HC Anderson children´s Hospital, OUH, Denmark
- PRINCIPAL INVESTIGATOR
Line H Toftlund, MD
HC Anderson children´s Hospital, OUH, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD student, doctor in medicine
Study Record Dates
First Submitted
February 28, 2014
First Posted
March 5, 2014
Study Start
October 1, 2010
Primary Completion
April 1, 2015
Study Completion
June 1, 2016
Last Updated
October 27, 2016
Record last verified: 2016-10