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Preterm Infants on Early Solid Foods (PIES-Project)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01809548
Recruitment Status : Active, not recruiting
First Posted : March 12, 2013
Last Update Posted : March 21, 2019
Information provided by (Responsible Party):
Nadja Haiden,MD, Medical University of Vienna

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2013
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

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 Name: 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 Name: commercially available solid food

Primary Outcome Measures :
  1. Height: [ Time Frame: 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 :
  1. neurodevelopmental outcome [ Time Frame: 5 years ]
    To achieve an improvement of neurodevelopmental outcome assessed by Bayley scales and the K-ABC

  2. IGF-1 [ Time Frame: 5 years ]
    To evaluate the risk for later obesity

  3. FX5 [ Time Frame: 5 years ]
    To achieve a reduction in risk for atopic diseases

  4. SCORAD [ Time Frame: 5 years ]
    To achieve a reduction in risk for atopic diseases.

  5. Body composition [ Time Frame: 5 years ]
    To achieve an increase of free fat mass (FFM) in body composition measured with the Peapod.

  6. Vitamin D [ Time Frame: 1 year ]
    To achieve a degree of bone mineralization.

  7. Iron status [ Time Frame: 1 year ]
    To achieve the development of anemia

  8. Leptin [ Time Frame: 5 years ]
    To evaluate the risk for later obesity

  9. BMI [ Time Frame: 5 years ]
    to evaluate anthropometric parameters

  10. weight [ Time Frame: 5 years ]
    to evaluate anthropometric parameters

  11. head circumference [ Time Frame: 5 years ]
    to evaluate anthropometric parameters

  12. z-scores [ Time Frame: 5 years ]
    to evaluate anthropometric parameters

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01809548

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Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
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Principal Investigator: Nadja Haiden Medical University of Vienna

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Responsible Party: Nadja Haiden,MD, Assoc.Prof.PD. MD, MSc, Medical University of Vienna Identifier: NCT01809548     History of Changes
Other Study ID Numbers: PIES001
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nadja Haiden,MD, Medical University of Vienna:
complementary feeding
premature infant
body composition
neurodevelopmental outcome
Additional relevant MeSH terms:
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Birth Weight
Failure to Thrive
Body Weight
Signs and Symptoms