Preterm Infants on Early Solid Foods (PIES-Project)
Primary Purpose
Infant, Very Low Birth Weight, Growth Failure
Status
Active
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Early intervention group
Late intervention group
Sponsored by
About this trial
This is an interventional treatment trial for Infant, Very Low Birth Weight focused on measuring complementary feeding, premature infant, body composition, atopy, neurodevelopmental outcome, obesity
Eligibility Criteria
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
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Early complementary feeding group
Late complementary feeding group:
Arm Description
Early intervention group: Introduction of early complementary feedings between the 10th -12th week of gestation corrected for prematurity
Late intervention group: Introduction of late complementary feedings between the 16th and 18th week of life corrected for prematurity
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
neurodevelopmental outcome
To achieve an improvement of neurodevelopmental outcome assessed by Bayley scales and the K-ABC
IGF-1
To evaluate the risk for later obesity
FX5
To achieve a reduction in risk for atopic diseases
SCORAD
To achieve a reduction in risk for atopic diseases.
Body composition
To achieve an increase of free fat mass (FFM) in body composition measured with the Peapod.
Vitamin D
To achieve a degree of bone mineralization.
Iron status
To achieve the development of anemia
Leptin
To evaluate the risk for later obesity
BMI
to evaluate anthropometric parameters
weight
to evaluate anthropometric parameters
head circumference
to evaluate anthropometric parameters
z-scores
to evaluate anthropometric parameters
Full Information
NCT ID
NCT01809548
First Posted
March 1, 2013
Last Updated
April 6, 2022
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT01809548
Brief Title
Preterm Infants on Early Solid Foods
Acronym
PIES-Project
Official Title
Early Introduction of Solid Foods in Preterm Infants: Effects on Growth, Atopy and Neurodevelopment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Very Low Birth Weight, Growth Failure
Keywords
complementary feeding, premature infant, body composition, atopy, neurodevelopmental outcome, obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study 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
Allocation
Randomized
Enrollment
177 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early complementary feeding group
Arm Type
Experimental
Arm Description
Early intervention group:
Introduction of early complementary feedings between the 10th -12th week of gestation corrected for prematurity
Arm Title
Late complementary feeding group:
Arm Type
Experimental
Arm Description
Late intervention group:
Introduction of late complementary feedings between the 16th and 18th week of life corrected for prematurity
Intervention Type
Other
Intervention Name(s)
Early intervention group
Other Intervention Name(s)
commercially available solid food
Intervention Description
solid food will be introduced between week 10 and 12
Intervention Type
Other
Intervention Name(s)
Late intervention group
Other Intervention Name(s)
commercially available solid food
Intervention Description
solid food is introduced between 16-18th week of gestation corrected for prematurity
Primary Outcome Measure Information:
Title
Height:
Description
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.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
neurodevelopmental outcome
Description
To achieve an improvement of neurodevelopmental outcome assessed by Bayley scales and the K-ABC
Time Frame
5 years
Title
IGF-1
Description
To evaluate the risk for later obesity
Time Frame
5 years
Title
FX5
Description
To achieve a reduction in risk for atopic diseases
Time Frame
5 years
Title
SCORAD
Description
To achieve a reduction in risk for atopic diseases.
Time Frame
5 years
Title
Body composition
Description
To achieve an increase of free fat mass (FFM) in body composition measured with the Peapod.
Time Frame
5 years
Title
Vitamin D
Description
To achieve a degree of bone mineralization.
Time Frame
1 year
Title
Iron status
Description
To achieve the development of anemia
Time Frame
1 year
Title
Leptin
Description
To evaluate the risk for later obesity
Time Frame
5 years
Title
BMI
Description
to evaluate anthropometric parameters
Time Frame
5 years
Title
weight
Description
to evaluate anthropometric parameters
Time Frame
5 years
Title
head circumference
Description
to evaluate anthropometric parameters
Time Frame
5 years
Title
z-scores
Description
to evaluate anthropometric parameters
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadja Haiden
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
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Preterm Infants on Early Solid Foods
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