An interventional study of NUTR + and STIMUL + in Infant, Very Low Birth Weight, sponsored by Università Politecnica delle Marche. Status unknown at 1 site in Italy. Open to participants aged 24 Weeks to 32 Weeks. Per ClinicalTrials.gov, last updated 2019-05-09.
Sponsored by Università Politecnica delle Marche · Not applicable, Interventional, and Treatment
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 .
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.
2,684 studies on the registry are indexed under Motor Activity; 1,217 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 2,344 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →Università Politecnica delle Marche is the lead sponsor of 48 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Standard Nutrition and no Physical Stimulation
Standard Nutrition and Physical Stimulation
Behavioral: STIMUL +
Enhanced Nutrition, and no Physical Stimulation
Dietary Supplement: NUTR +
Enhanced Nutrition and Physical Stimulation
Dietary Supplement: NUTR + · Behavioral: STIMUL +
one extra g/kg/d of protein and lipids starting before 48 hours after birth until 36 weeks postmenstrual age
Physical activity stimulation consists in flexion/extension of the 4 limbs and other motion exercises of the shoulder girdle and of the hips. This stimulation will take place before the feed for a mean of 30 times a week (minimum 24- maximum 36 times a week, 10 minutes each time) and will start within the 10th day of life until 36 weeks postmenstrual age
Weight gain (Birth-36 Weeks PMA)
Weight gain from birth up to 36 weeks postmenstrual age (g/kg/d)
Time frame: birth up to 36 weeks postmenstrual age
Muscle ultrasound
Ultrasound measurement of mid thigh and mid arm muscle thickness (cm)
Time frame: 32 weeks postmenstrual age (+-1d ), 34 weeks postmenstrual age(+-1d ), 36 weeks postmenstrual age(+-1d ), 40 weeks postmenstrual age(+-1d )
Adipose tissue ultrasound
Ultrasound measurement of mid thigh and mid arm adipose tissue thickness (cm)
Time frame: 32 weeks postmenstrual age(+-1d ), 34 weeks postmenstrual age(+-1d ), 36 weeks postmenstrual age(+-1d ), 40 weeks postmenstrual age(+-1d )
Lean body mass estimate using deuterium dilution
Urinary deuterium enrichment after 6 and 12 hours from deuterium oral administration (baseline)
Time frame: 36 weeks postmenstrual age (+-1d )
Skinfold thickness
Biceps and triceps skinfold thickness (both arms) (cm)
Time frame: 32 weeks postmenstrual age(+-1d ), 34 weeks postmenstrual age(+-1d ), 36 weeks postmenstrual age(+-1d ), 40 weeks postmenstrual age(+-1d ), between 22 and 24 months (2 years correct age)
Brain MRI
Brain injury, growth and maturation according to Kidokoro et al.
Time frame: 40 weeks postmenstrual age (+-1d )
Weight
weight measured by a digital infant scale (g)
Time frame: birth, daily up to 36 weeks postmenstrual age; 40weeks postmenstrual age (+-1d ), between 22 and 24 months (2 years correct age)
Total body length
Total body length measured by a neonatal stadiometer (cm)
Time frame: birth, weekly until 36 weeks postmenstrual age; 40weeks postmenstrual age (+-1d ), between 22 and 24 months (2 years correct age)
Head circumference
Head circumference measured by a flexible non-stretchable tape (cm)
Time frame: birth, weekly up to 36 weeks postmenstrual age; 40weeks postmenstrual age (+-1d ), between 22 and 24 months (2 years correct age)
Tibial length
Knee-heel length measured by knemometry (cm)
Time frame: birth, 32 weeks postmenstrual age(+-1d ), 34 weeks postmenstrual age(+-1d ), 36 weeks postmenstrual age(+-1d ), 40 weeks postmenstrual age(+-1d ), between 22 and 24 months (2 years correct age)
Weight gain (BW recovery-36W PMA)
Weight gain from the birth weight recovery until 36 weeks postmenstrual age (g/kg/d)
Time frame: birth weight recovery up to 36 weeks postmenstrual age
Bayley III Cognitive Score (MDI)
Cognitive scale (range 55-145). The Scale has index mean scores of 100 (SD ± 15). An index composite score of \< 70 (\>2 SD below the mean) is defined to indicate severe impairment, while an index composite score of 70-84 (\>1 SD below the mean) is defined to indicate mild impairment. Index composite scores ≥ 85 indicate normal development.
Time frame: between 22 and 24 months (2 years correct age)
Bayley III Language Score
Language scale (range 45-155). The Scale has index mean scores of 100 (SD ± 15). An index composite score of \< 70 (\>2 SD below the mean) is defined to indicate severe impairment, while an index composite score of 70-84 (\>1 SD below the mean) is defined to indicate mild impairment. Index composite scores ≥ 85 indicate normal development.
Time frame: between 22 and 24 months (2 years correct age)
Bayley III Motor Score (PDI)
Motor scale (range 45-155). The Scale has index mean scores of 100 (SD ± 15). An index composite score of \< 70 (\>2 SD below the mean) is defined to indicate severe impairment, while an index composite score of 70-84 (\>1 SD below the mean) is defined to indicate mild impairment. Index composite scores ≥ 85 indicate normal development.
Time frame: between 22 and 24 months (2 years correct age)
Safety (metabolic tolerance)
Plasma and urinary urea (mg/dl), Plasma triglycerides (mg/dl), blood glucose (mg/dl)
Time frame: At least daily during the first week of life, weekly up to 30 weeks postmenstrual age (when applicable), 30 weeks postmenstrual age (+-1d ), 32 weeks postmenstrual age (+-1d ), 34 weeks postmenstrual age (+-1d ), 36 weeks postmenstrual age (+-1d )
Safety (haematology)
Complete blood count
Time frame: At least daily during the first week of life, weekly up to 30 weeks postmenstrual age (when applicable), 30 weeks postmenstrual age (+-1d ), 32 weeks postmenstrual age (+-1d ), 34 weeks postmenstrual age (+-1d ), 36 weeks postmenstrual age (+-1d )
Safety (gas-analysis)
Gas-analisys
Time frame: At least daily during the first week of life, weekly up to 30 weeks postmenstrual age (when applicable), 30 weeks postmenstrual age (+-1d ), 32 weeks postmenstrual age (+-1d ), 34 weeks postmenstrual age (+-1d ), 36 weeks postmenstrual age (+-1d )
Bone mineralisation
Plasma and urinary calcium and phosphorus, alkaline phosphatase, parathyroid hormone, osteocalcin measurements
Time frame: 6 weeks of age, 32 weeks postmenstrual age (+-1d ), 34 weeks postmenstrual age (+-1d ), 36 weeks postmenstrual age (+-1d )
Bone ultrasound (1)
metacarpus speed of sound (m/s)
Time frame: 32 weeks postmenstrual age (+-1d ), 34 weeks postmenstrual age (+-1d ), 36 weeks postmenstrual age (+-1d )
Bone ultrasound (2)
Metacarpus bone transmission time (ms)
Time frame: 32 weeks postmenstrual age (+-1d ), 34 weeks postmenstrual age (+-1d ), 36 weeks postmenstrual age (+-1d )
Measurement of physical activity
Different levels of activity are assigned according to the Bruck's activity scale as described by Freymond et al. (24 hour continuous recording using a video camera). Levels of activity are defined as follows: 0, no body, arm, or leg movement, facial movement present or not with eyes closed or open; 1, arm or leg movement with eyes closed or open; 2, total body movement with eyes closed or open; 3, crying. Levels of activity in each group are expressed as percentage of time spent during the day in each level.
Time frame: 32 weeks postmenstrual age (+-1d ), 34 weeks postmenstrual age (+-1d ), 36 weeks postmenstrual age (+-1d ), 40 weeks postmenstrual age (+-1d) if still hospitalized
Morbidity
incidence of the main complication of prematurity
Time frame: Hospital stay, on average 36 weeks postmenstrual age
Mortality
incidence of mortality
Time frame: hospital stay, on average 36 weeks postmenstrual age
Plan to share: Undecided
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Università Politecnica delle Marche