The main objective of this study is to analyze the effect of early (12 weeks corrected age) versus late (17 weeks corrected age) introduction of complementary food (weaning) on the prevalence of obesity at the age of 2 years in preterm infants.…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
preterm infants, complementary feeding, obesity
Research involving
Sponsors and support
Intervention
- Food (substances)
Outcome measures
Primary outcome
Secondary outcome
- Eating behavior and tolerating complementary feeding: to determine if early introduction is correlated with less eating problems in comparison to introduction the late introduction, by using the Baby Eating Behaviour Questionnaire (BEBQ) and Child Feeding Questionnaire (CFQ).
- Eating behavior and tolerating complementary feeding: to determine if term born infants (control group) have less eating problems in comparison to preterm infants before the start of complementary feeding, by using the Baby Eating Behaviour Questionnaire (BEBQ)
- Growth parameters (weight, length, head circumference, BMI, weight-for-age, length-for-age, head circumference-for-age): comparing the growth parameters of preterm infants with term infants before the start of complementary feeding, at 1 year and at 2 years
- Health Related Quality of life (HRQoL): to evaluate the difference in HRQoL between early versus late introduction of complementary feeding, by using The Infant Toddler Quality of Life (ITQoL) Questionnaire or Pediatric Quality of Life Inventory (PedsQL).
- Ages and Stages Questionnaire (ASQ): to evaluate the difference in development between early versus late introcution of complementary feeding, by using the ASQ at the age of 1 and 2 years.
- Allergy/Atopic: to evaluate if the incidence of allergies is different between early versus late introduction of complementary feeding, by using the SCORAD.
- Microbiota: to evaluate if the microbiota change due to the introduction of complementary feeding
Background summary
Optimal timing of 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, including overweight and obesity.
Study objective
The main objective of this study is to analyze the effect of early (12 weeks corrected age) versus late (17 weeks corrected age) introduction of complementary food (weaning) on the prevalence of obesity at the age of 2 years in preterm infants. Overweight (including obesity) is determined by measuring the BMI, according to the IOTF cut-off values. Preterm infants are included when born between 30 and 36 weeks of gestational age.
Study design
Multicenter randomized controlled trial
Intervention
Randomization between starting with complementary feeding at 12 weeks corrected age and 17 weeks corrected age
Study burden and risks
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, and eating behaviour in preterm infants it is important to perform this study in this age category.
Karin Vissers
[default]
The Netherlands
(0318) 43 5046
vissersk@zgv.nl
Karin Vissers
[default]
The Netherlands
(0318) 43 5046
vissersk@zgv.nl
Age
Inclusion criteria
1. Preterm infants born at gestational age between 30 and 36 weeks
2. Written informed consent from both parents, or legal representive
For control groep
1. Term born infant (born between 37 and 42 weeks of gestational age)
2. Written informed consent from both parents, or legal representive
Exclusion criteria
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4799 |
| NTR-old | NTR4939 |
| CCMO | NL50601.029.14 |
| OMON | NL-OMON53076 |