High Protein and High Energy Intakes and Physical Activity on Growth of Extremely Low Birth Weight Infants

  • STATUS
    Recruiting
  • days left to enroll
    35
  • participants needed
    200
  • sponsor
    Università Politecnica delle Marche
Updated on 25 February 2022

Summary

The aim of this study is to evaluate the effect of increasing amino acid and energy intake during parenteral and enteral nutrition with and without the stimulation of the infant's physical activity, on growth of extremely low birth weight infants .

Description

Increasing protein and energy intake above the anabolic capacity of a given individual may result in increased lipogenesis and excessive fat deposition. Adults with reduced mobility or with neuromuscular conditions will develop excessive fat deposition if they receive normal to high protein and energy intakes. Excessive fat deposition have been demonstrated in preterm infants receiving high energy intakes. Given that physical activity in preterms is often reduced for the prematurity itself, the associated sickness and the numerous medications, the investigators speculate that physical stimulation may have a beneficial effect on protein accretion and on lean mass accretion. The investigators further hypothesize that today's recommended daily intakes of proteins and energy cannot be fully incorporated into lean body mass without a concomitant physical activity. In spite of the fact that this notion is well accepted in adult physiology and in the elderly, it has never been tested in preterm infants.

This factorial randomised controlled trial will evaluate the effect of increasing amino acid intake (by 1 g/kg/d) and energy intake (by 20 kcal/kg/d) during parenteral nutrition and also of increasing protein intake and energy intake by an extra 1 g/kg/d during enteral nutrition, with and without the stimulation of the infant's physical activity, on growth of extremely low birth weight infants. The investigators aim at demonstrating that increasing energy and protein intake above the standard of care intakes will result in better growth only in association with adequate physical activity, in particular in relation to body composition and lean mass accretion.

Details
Condition Infant, Very Low Birth Weight
Treatment NUTR +, STIMUL +
Clinical Study IdentifierNCT03374033
SponsorUniversità Politecnica delle Marche
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

weeks < gestational age < 32 weeks
inborn or outborn admitted before 24 hours of age
parenteral or enteral nutrition start before 48 hours of age
parental consent

Exclusion Criteria

difficulty in starting physical activity stimulation before 10 days of life
death before 36 W PMA
diagnosis of necrotising enterocolitis (before 36 W PMA)
any major surgery (before 36 W PMA)
congenital syndrome, severe malformations
inborn errors of metabolism
parental consent withdrawn
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