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. Furthermore, the effect of complementary feeding on body…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
BMI at the age of 2 years (association)
Secondary outcome
1) Body composition
2) Eating behavior of the child by using and tolerating complementary feeding
3) Quality of life
4) Allergies using the SCORAD
5) Microbiome
Background summary
Limited evidence is available about the optimal age of the start of
complementary feeding in preterm infants and implications for both short and
long term health. Complementary feeding is defined as the introduction of
non-(breast) milk foods or nutritive liquids when milk alone is no longer
sufficient to meet all nutritional requirements. In this period, there is a
gradual transition to eating family foods. Timely introduction of complementary
feeding during infancy is necessary for both nutritional and developmental
reasons. Complementary feeding is associated with major changes in both
macronutrient and micronutrient intake. Early complementary feeding in term
infants is suggested to be a risk factor for childhood obesity. Childhood
obesity is associated with major health risks. There is evidence that
overweight youth are at increased risk of remaining overweight. However, these
results concern term-born infants and cannot be directly translated to preterm
infants. To determine correlations between the start of complementary feeding
and obesity it is important to perform this study.
Study 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. Furthermore, the effect of complementary feeding on
body composition, eating behaviour, quality of life, and microbiome will be
determined.
Study design
Randomized parallel group open-label controlled intervention study.
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 welfare centre in the Netherlands.
Study burden and risks
The burden and risks associated with participation to this study are minimal.
The benefits of starting early complementary feeding are well described by
King. King suggested that it is not necessary to wait for lip seal to develop
and tongue protrusion to diminish before weaning. In fact, premature children
may only mature with the aid of weaning. Furthermore, some infants may develop
rapidly with increasingly textured food. There is evidence for not starting
complementary feeding before 3 months corrected age, because motor development
necessary for safe and successful transition to solid foods may not have been
achieved until at least 3 months. For that reason, none of the children will
start complementary feeding before 3 months of age corrected age. From data on
term infants it seems likely that the later a preterm infant is introduced to
new tastes, the less likely they are to accept a wide variety of foods. King
also puts forward that there is no evidence that preterm infants are more
likely to develop atopic diseases due to immaturity of the gut and immune
system.
For the primary outcome we would like to determine BMI at the age of 2 years.
Additionally, we would like to determine BMI before the start of complementary
feeding and at the age of 1 year. Ideally, we would like to combine these
hospital visits with regular visits in the follow-up of the preterm infants.
Furthermore, we would like to have extra information on the microbiome
requiring faeces samples. Faeces samples are taken at three different time
points in both groups. Parents are asked to collect the faeces at home.
In conclusion, we would like to obtain information before the start of
complementary feeding and at the age of 1 and 2 years. This means three extra
hospital visits, depending on the arrangement for the follow-up of preterm
infants in the different hospitals. Whenever possible, visits for the study
will be combined with regular visits. 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, eating behaviour
and microbiome in preterm infants it is important to perform this study.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
premature infants, born between 30 and 35 6/7 weeks gestational age., preterm
infants, born between 37 and 42 weeks gestational age.
Exclusion criteria
• Diseases interfering with stable growth
• Dysmaturity
• Intestinal disorders
• Bronchopulmonary dysplasia (BPD)
• Kidney disorders
• Congenital heart disease with hemodynamic consequences
• Severe cow milk allergy
• Congenital anomalies ENT area, esophageal and or tracheal, needing operative
correction
• Syndromal disorders
• Intra ventricular hemorrhage grade III or IV
• No motivation of parents
• No informed consent, Term born children:
- Small for Gestational Age (SGA) (- Diseases interfering with stable growth
- Intestinal disorders (necrotizing enterocolitis needing surgery, short bowel
syndrome, hirschsprung disease, inflammatory bowel disease)
- Moderate and severe bronchopulmonary dysplasia (BPD) defined according to the
international criteria
- Kidney disorders
- Congenital heart disease with hemodynamic consequences
- Severe cow milk allergy (Samson score > 3)
- Congenital anomalies Ear Nose Troat (ENT) area, esophageal and or tracheal,
needing operative correction (e.g. cheilognatopalatoschizes, esophageal atresia)
- Syndromal disorders (e.g. trisomie 21, PraderWilli)
- Intra ventricular hemorrhage grade III or IV
- No motivation of parents
- No informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL50601.029.14 |
Other | www.trialregister.nl en www.clinicaltrials.gov. Studie is aangemeld. Identificatienummers volgen. |