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Preterm Infants on Early Solid Foods

NCT01809548 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2022-04-07

No results posted yet for this study

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

Interventions

OTHER

Early intervention group

solid food will be introduced between week 10 and 12

OTHER

Late intervention group

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

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Nadja Haiden · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2020-03-30
Completion
2024-12-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01809548 on ClinicalTrials.gov