PIES-Project: Preterm Infants on Early Solid Foods

Sponsor

Medical University of Vienna (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01809548

Collaborator

(none)

177

Enrollment

Location

Arms

134

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infant, Very Low Birth Weight Growth Failure	Other: Early intervention group Other: Late intervention group	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

177 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

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

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Mar 30, 2020

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early complementary feeding group Early intervention group: Introduction of early complementary feedings between the 10th -12th week of gestation corrected for prematurity	Other: Early intervention group solid food will be introduced between week 10 and 12 Other Names: commercially available solid food
Experimental: Late complementary feeding group: Late intervention group: Introduction of late complementary feedings between the 16th and 18th week of life corrected for prematurity	Other: Late intervention group solid food is introduced between 16-18th week of gestation corrected for prematurity Other Names: commercially available solid food

Arm

Intervention/Treatment

Experimental: Early complementary feeding group

Early intervention group: Introduction of early complementary feedings between the 10th -12th week of gestation corrected for prematurity

Other: Early intervention group

solid food will be introduced between week 10 and 12

Other Names:

commercially available solid food

Experimental: Late complementary feeding group:

Late intervention group: Introduction of late complementary feedings between the 16th and 18th week of life corrected for prematurity

Other: Late intervention group

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

Other Names:

commercially available solid food

Outcome Measures

Primary Outcome Measures

Height: [1 Year]
To 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 Outcome Measures

neurodevelopmental outcome [5 years]
To achieve an improvement of neurodevelopmental outcome assessed by Bayley scales and the K-ABC
IGF-1 [5 years]
To evaluate the risk for later obesity
FX5 [5 years]
To achieve a reduction in risk for atopic diseases
SCORAD [5 years]
To achieve a reduction in risk for atopic diseases.
Body composition [5 years]
To achieve an increase of free fat mass (FFM) in body composition measured with the Peapod.
Vitamin D [1 year]
To achieve a degree of bone mineralization.
Iron status [1 year]
To achieve the development of anemia
Leptin [5 years]
To evaluate the risk for later obesity
BMI [5 years]
to evaluate anthropometric parameters
weight [5 years]
to evaluate anthropometric parameters
head circumference [5 years]
to evaluate anthropometric parameters
z-scores [5 years]
to evaluate anthropometric parameters

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Week to 3 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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