Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01809548
Recruitment Status : Active, not recruiting
First Posted : March 12, 2013
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Nadja Haiden,MD, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE March 1, 2013
First Posted Date  ICMJE March 12, 2013
Last Update Posted Date March 21, 2019
Study Start Date  ICMJE October 2013
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01809548 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2018)
  • neurodevelopmental outcome [ Time Frame: 5 years ]
    To achieve an improvement of neurodevelopmental outcome assessed by Bayley scales and the K-ABC
  • IGF-1 [ Time Frame: 5 years ]
    To evaluate the risk for later obesity
  • FX5 [ Time Frame: 5 years ]
    To achieve a reduction in risk for atopic diseases
  • SCORAD [ Time Frame: 5 years ]
    To achieve a reduction in risk for atopic diseases.
  • Body composition [ Time Frame: 5 years ]
    To achieve an increase of free fat mass (FFM) in body composition measured with the Peapod.
  • Vitamin D [ Time Frame: 1 year ]
    To achieve a degree of bone mineralization.
  • Iron status [ Time Frame: 1 year ]
    To achieve the development of anemia
  • Leptin [ Time Frame: 5 years ]
    To evaluate the risk for later obesity
  • BMI [ Time Frame: 5 years ]
    to evaluate anthropometric parameters
  • weight [ Time Frame: 5 years ]
    to evaluate anthropometric parameters
  • head circumference [ Time Frame: 5 years ]
    to evaluate anthropometric parameters
  • z-scores [ Time Frame: 5 years ]
    to evaluate anthropometric parameters
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2013)
  • neurodevelopmental outcome [ Time Frame: 5 years ]
    To achieve an improvement of neurodevelopmental outcome assessed by Bayley scales and the Kaufmann-ABC
  • IGF-1 [ Time Frame: 5 years ]
    To evaluate the risk for later obesity
  • FX5 [ Time Frame: 5 years ]
    To achieve a reduction in risk for atopic diseases
  • SCORAD [ Time Frame: 5 years ]
    To achieve a reduction in risk for atopic diseases.
  • Body composition [ Time Frame: 5 years ]
    To achieve an increase of free fat mass (FFM) in body composition measured with the Peapod.
  • Vitamin D [ Time Frame: 1 year ]
    To achieve a degree of bone mineralization.
  • Iron status [ Time Frame: 1 year ]
    To achieve the development of anemia
  • Leptin [ Time Frame: 5 years ]
    To evaluate the risk for later obesity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preterm Infants on Early Solid Foods
Official Title  ICMJE Early Introduction of Solid Foods in Preterm Infants: Effects on Growth, Atopy and Neurodevelopment
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Infant, Very Low Birth Weight
  • Growth Failure
Intervention  ICMJE
  • Other: Early intervention group
    solid food will be introduced between week 10 and 12
    Other Name: commercially available solid food
  • Other: Late intervention group
    solid food is introduced between 16-18th week of gestation corrected for prematurity
    Other Name: commercially available solid food
Study Arms  ICMJE
  • Experimental: Early complementary feeding group

    Early intervention group:

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

    Intervention: Other: Early intervention group
  • Experimental: Late complementary feeding group:

    Late intervention group:

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

    Intervention: Other: Late intervention group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 19, 2019)
177
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2013)
198
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 3 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01809548
Other Study ID Numbers  ICMJE PIES001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nadja Haiden,MD, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nadja Haiden Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP