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Preterm Infants on Early Solid Foods

Early Introduction of Solid Foods in Preterm Infants: Effects on Growth, Atopy and Neurodevelopment

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01809548
Acronym
PIES-Project
Enrollment
177
Registered
2013-03-12
Start date
2013-10-31
Completion date
2024-12-31
Last updated
2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Failure, Infant, Very Low Birth Weight

Keywords

complementary feeding, premature infant, body composition, atopy, neurodevelopmental outcome, obesity

Brief summary

Introduction: Preterm infants with a birth weight less than 1500 grams have special nutritional needs in comparison to full-term neonates. During their stay in the neonatal intensive care unit an increased supply with energy, protein and electrolytes is necessary to establish adequate growth. After discharge from the hospital special breast milk supplements or post discharge formulas are available to cover the special nutrient requirements. Complementary feeding in preterm infants is an unexplored field so far and nutritional concepts for the first year of life are not available. Data concerning the optimal time for starting solid foods are missing as well as information concerning the ideal composition of complementary food. In this context it is essential to meet the special nutritional needs of Ex-Preemies on the one hand and avoid overfeeding and later obesity on the other hand. So far it remains unclear, what the safe time point for introduction of solid food to premature infants is and whether this time point influences growth, body composition, neurodevelopmental outcome or the incidence of atopic disease.

Detailed description

Aim: In a prospective, randomized, two arm intervention study- the PIES project- we aim to investigate the impact of different time points of introduction of complementary food on growth, body composition, atopic disease and neurodevelopmental outcome in preterm infant with a birth weight \<1500 grams. Furthermore, we want to investigate whether a certain standardized feeding protocol meets the nutritional needs of premature infants, and obtain data on safety and efficacy in this context. Methods: At term infants are stratified according to breastfed or formula fed and randomized in one of the following groups: an EARLY complementary feeding group (introduction of complementary food between the 10th and 12th week of life corrected for term, n=76) and LATE complementary feeding group (introduction of complementary food between the 16th and 18th week of life corrected for term, n=76). The infants will be fed with standardized complementary food in addition to formula or breastfeeding until they are one year corrected for prematurity. In an age dependent step up concept, food boxes are delivered to the parents: five types of standardized food boxes with manifold complementary food according to the infants' age and the ability to tolerate small pieces are available for each child during the study. The standardized complementary feeding regimen allows calculating exact intake of nutrients and therefore will provide information concerning primary and secondary outcome. The follow up phase will last until 5 years of age. Within regular visits anthropometric data (height, head circumference, weight, BMI and z-scores ) and body composition via the PeaPod® system will be gathered. Data on atopy will be assessed by clinical scoring system SCORAD (SCORing Atopic Dermatitis) and the laboratory parameters Fx5(Fx5 test uses six food allergens: wheat, egg, cow's milk, soya, peanut and fish) and IgE (immuneglobulineE). Neurodevelopmental outcome will be assessed at the age of one and two years corrected for term by the Bayley Scales and the K-ABC (Kaufman Assessment Battery for Children). The nutritional concept will be monitored concerning short term safety and efficacy (bone metabolism, iron status, protein- and lipid status) as well as regarding long term outcome (diabetes and obesity markers IGF-1 (Insulin-like growth factor-1, adiponectin and leptin). With the PIES project we intend to close a gap of knowledge in feeding the premature infant during the first year of life and to understand the impact of complementary feeding on growth, atopy, neurodevelopmental outcome and later obesity.

Interventions

solid food will be introduced between week 10 and 12

OTHERLate intervention group

solid food is introduced between 16-18th week of gestation corrected for prematurity

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

After interim analysis switch from prospective randomised to baseline adaptive randomised controlled - stratified according birthweight below /equal 800g and equal/more than 801 grams. After an interim analysis 1/2019: During the whole study period we had a very low drop out rate of 11% so far. Therefore we adapt the sample size calculation from the anticipated 30% drop out rate to an one-to-one replacement for dropouts + a surplus of 5 patients

Eligibility

Sex/Gender
ALL
Age
1 Weeks to 3 Months
Healthy volunteers
No

Inclusion criteria

* Preterm infants \<1500 gram * Informed consent

Exclusion criteria

Diseases affecting stable growth: * Gastrointestinal diseases: necrotizing enterocolitis, Hirschsprung disease, chronic inflammatory bowel disease * Bronchopulmonary dysplasia (BPD) defined as oxygen demand above 36 week gestational age * Congenital heart diseases * major congenital birth defects * chromosomal aberrations

Design outcomes

Primary

MeasureTime frameDescription
Height:1 YearTo investigate whether a height difference of 5% at one year of age, corrected for prematurity, can be achieved between the early and the late intervention group. Height will be measured under standardized conditions in centimeter (cm) at defined times during the first year of life until one year of age corrected for prematurity. Measurements will be done before, within and after intervention in order to demonstrate the changes due to all intervention tools.

Secondary

MeasureTime frameDescription
IGF-15 yearsTo evaluate the risk for later obesity
FX55 yearsTo achieve a reduction in risk for atopic diseases
SCORAD5 yearsTo achieve a reduction in risk for atopic diseases.
Body composition5 yearsTo achieve an increase of free fat mass (FFM) in body composition measured with the Peapod.
Vitamin D1 yearTo achieve a degree of bone mineralization.
neurodevelopmental outcome5 yearsTo achieve an improvement of neurodevelopmental outcome assessed by Bayley scales and the K-ABC
Leptin5 yearsTo evaluate the risk for later obesity
BMI5 yearsto evaluate anthropometric parameters
weight5 yearsto evaluate anthropometric parameters
head circumference5 yearsto evaluate anthropometric parameters
z-scores5 yearsto evaluate anthropometric parameters
Iron status1 yearTo achieve the development of anemia

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 10, 2026