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

Università Politecnica delle Marche

Status: Unknown

Conditions: Infant, Very Low Birth Weight

Treatments: Dietary Supplement: NUTR +; Behavioral: STIMUL +

Study type: Interventional

Funder types: Other

Identifiers

NCT03374033

DG-297

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 24 to 32 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 24 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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200 participants in 4 patient groups

NUTR (Nutrition) 0_STIMUL(Stimulation) 0

No Intervention group

Description:

Standard Nutrition and no Physical Stimulation

NUTR 0_STIMUL +

Experimental group

Description:

Standard Nutrition and Physical Stimulation

Treatment:

Behavioral: STIMUL +

NUTR +_STIMUL 0

Experimental group

Description:

Enhanced Nutrition, and no Physical Stimulation

Treatment:

Dietary Supplement: NUTR +

NUTR +_STIMUL +

Experimental group

Description:

Enhanced Nutrition and Physical Stimulation

Treatment:

Dietary Supplement: NUTR +

Behavioral: STIMUL +