Preterm Infants on Early Solid Foods

NCT01809548 | Unknown DMC

• 1 other identifier: PIES001
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Very Low Birth Weight; Growth Failure

Keywords

complementary feeding; premature infant; body composition; atopy; neurodevelopmental outcome; obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• neurodevelopmental outcome

  5 years

• IGF-1

  5 years

• FX5

  5 years

• SCORAD

  5 years

• Body composition

  5 years

Study Arms (2)

Early complementary feeding group

EXPERIMENTAL

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

Other: Early intervention group

Late complementary feeding group:

EXPERIMENTAL

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

Other: Late intervention group

Interventions

Early intervention group OTHER

solid food will be introduced between week 10 and 12

Also known as: commercially available solid food

Early complementary feeding group

Late intervention group OTHER

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

Also known as: commercially available solid food

Late complementary feeding group:

Eligibility Criteria

• Age: 1 Week - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants \<1500 gram
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• Gsoellpointner M, Eibensteiner F, Thanhaeuser M, Ristl R, Jilma B, Berger A, Haiden N. Effects of early introduction of solid foods on nutrient intake in preterm infants during their 1st year of life: a secondary outcome analysis of a prospective, randomized intervention study. Front Nutr. 2023 May 18;10:1124544. doi: 10.3389/fnut.2023.1124544. eCollection 2023.

  PMID: 37275631 DERIVED

MeSH Terms

Conditions

Failure to Thrive; Premature Birth; Obesity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Officials

• Nadja Haiden

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.PD. MD, MSc

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 12, 2013
• Study Start: October 1, 2013
• Primary Completion: March 30, 2020
• Study Completion: December 1, 2024
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)