Preterm Infants on Early Solid Foods (PIES-Project)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Growth Failure; Infant, Very Low Birth Weight
• Intervention / Treatment: Other: Early intervention group; Other: Late intervention group

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 Type: Interventional
• Enrollment (Actual): 177
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height:	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.	1 Year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Nadja Haiden, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): March 30, 2020
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: March 1, 2013
• First Submitted That Met QC Criteria: March 9, 2013
• First Posted (Estimate): March 12, 2013

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: obesity; body composition; premature infant; atopy; neurodevelopmental outcome; complementary feeding
• Additional Relevant MeSH Terms: Body Weight; Birth Weight; Failure to Thrive
• Other Study ID Numbers: PIES001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No