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Timing of complementary feeding in preterm infants and the effect on obesity.


- candidate number21014
- NTR NumberNTR4939
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-nov-2014
- Secondary IDsNL50601.029.14 
- Public TitleTiming of complementary feeding in preterm infants and the effect on obesity.
- Scientific TitleSolid foods in Preterm infants and the effect On Obesity in the Netherlands.
- ACRONYMSPOON
- hypothesisThe aim of the study is to analyze the effect of early (12 weeks corrected age) versus late (17 weeks corrected age) introduction of complementary feeding on obesity at the age of 2 years in preterm infants.
- Healt Condition(s) or Problem(s) studiedPremature infants, Obesity, Complementary feeding
- Inclusion criteria1. Preterm infants born at gestational age 30 and 35 6⁄7 weeks 2. Informed consent from both parents
- Exclusion criteria1. Small for Gestational Age (SGA) 2. Diseases interfering with stable growth 3. Twins or triplets 4. Intestinal disorders (necrotizing enterocolitis needing surgery, short bowel syndrome, hirschsprung disease, inflammatory bowel disease) 5. Moderate and severe bronchopulmonary dysplasia (BPD) defined according to the international criteria 6. First degree family member with celiac disease 7. Kidney disorders 8. Congenital heart disease with hemodynamic consequences 9. Severe cow milk allergy 10. Congenital anomalies Ear Nose Troat (ENT) area, esophageal and or tracheal, needing operative correction 11. Syndromal disorders 12. Intra ventricular hemorrhage grade III or IV 13. No motivation of parents 14. No informed consent
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2016
- planned closingdate1-mei-2020
- Target number of participants600
- InterventionsComplementary feeding at 12 weeks (early) or 17 weeks (late) weeks of corrected age.
- Primary outcomeThe incidence of obesity determined by measuring the BMI.
- Secondary outcome1. Eating behavior of the child by using and tolerating complementary feeding, by using the BEBQ and CFQ 2. Quality of life: HRQOoL by using the ITQoL or PedsQL 3. Allergies, by using the SCORAD 4. Neurological developmental state Subsample of 150 patients: 1. Iron- and vitamin D status 2. Inflammatory markers 3. Metabolomics and microbiome 4. Body composition
- Timepoints- Primary outcome: 2 years of age - Questionnaire: four times during the follow up of 2 years - Secundary outcome: 1 year and 2 years of age - Subsample of secundary outcome: 6 months and 2 years
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESArts-assistent / Arts-onderzoeker Karin Vissers
- CONTACT for SCIENTIFIC QUERIESProf. dr. Hans Goudoever, van
- Sponsor/Initiator Ziekenhuis Gelderse Vallei
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research Foundation
- PublicationsN/A
- Brief summaryRationale: timely introduction of complementary feeding during infancy is necessary for both nutritional and developmental reasons. Limited evidence is available about the optimal age of solid food introduction in preterm infants and implications for both short and long term health. Objective: to analyze the effect of early (12 weeks corrected age) versus late (17 weeks corrected age) introduction of complementary feeding on obesity at the age of 2 years in preterm infants. Study design: the study comprises a randomized parallel group open-label controlled intervention study in which premature born children will be randomized to receive complementary feeding at the corrected age of 12 weeks or at the corrected age of 17 weeks. Study population: preterm infants born between 30 and 35 6⁄7 weeks gestational age. Intervention: the intervention group will start complementary feeding at 12 weeks corrected age. The control group will start complementary feeding at the corrected age of 17 weeks. The pattern and structure of the complementary feeding will be according to the advice of the well baby clinics in the Netherlands. Main study parameter/endpoint: the main study parameter is the incidence of obesity at the age of 2 years determined by BMI-score, according to the IOTF cut-off values. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: the risks associated with this study are minimal. There will be no benefit for the individual participating in this study. To determine correlations between height, weight, BMI, body composition, eating behaviour and biomarkers in preterm infants it is important to perform this study in this age category.
- Main changes (audit trail)
- RECORD20-nov-2014 - 5-jan-2016


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