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Infant, Very Low Birth WeightNCT03374033

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

A study testing NUTR + and STIMUL + in people with Infant, Very Low Birth Weight, run by Università Politecnica delle Marche at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 24 to 32 weeks
Conditions the study is for
Infant, Very Low Birth Weight
What is being tested?
NUTR + and STIMUL +
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteItaly
Study dates
10 Apr 2017to 30 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 32 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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  • parental consent withdrawn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 locations and contacts

1 site in 1 country.

Virgilio P. Carnielli, MD, PhD contact

00390715962045

v.carnielli@univpm.it

Chiara Biagetti, MD contact

00390715962014

chiara.biagetti@ospedaliriuniti.marche.it

Italy1 site, 1 recruiting

  • Ospedale G. Salesi

    Ancona, 60123

    Virgilio P. Carnielli, MD, PhD, 00390715962045, v.carnielli@univpm.it

    Chiara Biagetti, MD, 00390715962014, chiara.biagetti@ospedaliriuniti.marche.it

    Recruiting

Other trials in Italy

About this study

Official title: Effect of High Protein and High Energy Intakes and Physical Activity on Growth and Body Composition of Extremely Low Birth Weight Infants: a Randomised Controlled Trial.

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 .

Read the detailed 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.

Being tested
NUTR +, STIMUL +
Keywords
Preterm infants, growth, nutrition, physical activity
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NUTR +Dietary supplement

    one extra g/kg/d of protein and lipids starting before 48 hours after birth until 36 weeks postmenstrual age

  • STIMUL +Behavioural

    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

Study groups in NCT03374033
Study groupRoleWhat they receive
NUTR (Nutrition) 0_STIMUL(Stimulation) 0No interventionStandard Nutrition and no Physical Stimulation
NUTR 0_STIMUL +ExperimentalStandard Nutrition and Physical Stimulation
Receives: Behavioral: STIMUL +
NUTR +_STIMUL 0ExperimentalEnhanced Nutrition, and no Physical Stimulation
Receives: Dietary Supplement: NUTR +
NUTR +_STIMUL +ExperimentalEnhanced Nutrition and Physical Stimulation
Receives: Dietary Supplement: NUTR +; Behavioral: STIMUL +

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight gain (Birth-36 Weeks PMA)

    Weight gain from birth up to 36 weeks postmenstrual age (g/kg/d)

    Measured: birth up to 36 weeks postmenstrual age

Secondary outcomes (22)

  1. Muscle ultrasound

    Ultrasound measurement of mid thigh and mid arm muscle thickness (cm)

    Measured: 32 weeks postmenstrual age (+-1d ), 34 weeks postmenstrual age(+-1d ), 36 weeks postmenstrual age(+-1d ), 40 weeks postmenstrual age(+-1d )

  2. Adipose tissue ultrasound

    Ultrasound measurement of mid thigh and mid arm adipose tissue thickness (cm)

    Measured: 32 weeks postmenstrual age(+-1d ), 34 weeks postmenstrual age(+-1d ), 36 weeks postmenstrual age(+-1d ), 40 weeks postmenstrual age(+-1d )

  3. Lean body mass estimate using deuterium dilution

    Urinary deuterium enrichment after 6 and 12 hours from deuterium oral administration (baseline)

    Measured: 36 weeks postmenstrual age (+-1d )

  4. Skinfold thickness

    Biceps and triceps skinfold thickness (both arms) (cm)

    Measured: 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)

  5. Brain MRI

    Brain injury, growth and maturation according to Kidokoro et al.

    Measured: 40 weeks postmenstrual age (+-1d )

  6. Weight

    weight measured by a digital infant scale (g)

    Measured: birth, daily up to 36 weeks postmenstrual age; 40weeks postmenstrual age (+-1d ), between 22 and 24 months (2 years correct age)

  7. Total body length

    Total body length measured by a neonatal stadiometer (cm)

    Measured: birth, weekly until 36 weeks postmenstrual age; 40weeks postmenstrual age (+-1d ), between 22 and 24 months (2 years correct age)

  8. Head circumference

    Head circumference measured by a flexible non-stretchable tape (cm)

    Measured: birth, weekly up to 36 weeks postmenstrual age; 40weeks postmenstrual age (+-1d ), between 22 and 24 months (2 years correct age)

  9. Tibial length

    Knee-heel length measured by knemometry (cm)

    Measured: 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)

  10. Weight gain (BW recovery-36W PMA)

    Weight gain from the birth weight recovery until 36 weeks postmenstrual age (g/kg/d)

    Measured: birth weight recovery up to 36 weeks postmenstrual age

  11. 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.

    Measured: between 22 and 24 months (2 years correct age)

  12. 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.

    Measured: between 22 and 24 months (2 years correct age)

  13. 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.

    Measured: between 22 and 24 months (2 years correct age)

  14. Safety (metabolic tolerance)

    Plasma and urinary urea (mg/dl), Plasma triglycerides (mg/dl), blood glucose (mg/dl)

    Measured: 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 )

  15. Safety (haematology)

    Complete blood count

    Measured: 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 )

  16. Safety (gas-analysis)

    Gas-analisys

    Measured: 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 )

  17. Bone mineralisation

    Plasma and urinary calcium and phosphorus, alkaline phosphatase, parathyroid hormone, osteocalcin measurements

    Measured: 6 weeks of age, 32 weeks postmenstrual age (+-1d ), 34 weeks postmenstrual age (+-1d ), 36 weeks postmenstrual age (+-1d )

  18. Bone ultrasound (1)

    metacarpus speed of sound (m/s)

    Measured: 32 weeks postmenstrual age (+-1d ), 34 weeks postmenstrual age (+-1d ), 36 weeks postmenstrual age (+-1d )

  19. Bone ultrasound (2)

    Metacarpus bone transmission time (ms)

    Measured: 32 weeks postmenstrual age (+-1d ), 34 weeks postmenstrual age (+-1d ), 36 weeks postmenstrual age (+-1d )

  20. 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.

    Measured: 32 weeks postmenstrual age (+-1d ), 34 weeks postmenstrual age (+-1d ), 36 weeks postmenstrual age (+-1d ), 40 weeks postmenstrual age (+-1d) if still hospitalized

  21. Morbidity

    incidence of the main complication of prematurity

    Measured: Hospital stay, on average 36 weeks postmenstrual age

  22. Mortality

    incidence of mortality

    Measured: hospital stay, on average 36 weeks postmenstrual age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2017
  2. Study start10 Apr 2017
  3. Primary completion3 Apr 2020 (estimated)
  4. Study completion30 Jul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03374033
Sponsor's protocol ID
DG-297
Status last verified
May 2019
First submitted
13 Nov 2017
Last updated
9 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Agostoni C, Buonocore G, Carnielli VP, De Curtis M, Darmaun D, Decsi T, Domellof M, Embleton ND, Fusch C, Genzel-Boroviczeny O, Goulet O, Kalhan SC, Kolacek S, Koletzko B, Lapillonne A, Mihatsch W, Moreno L, Neu J, Poindexter B, Puntis J, Putet G, Rigo J, Riskin A, Salle B, Sauer P, Shamir R, Szajewska H, Thureen P, Turck D, van Goudoever JB, Ziegler EE; ESPGHAN Committee on Nutrition. Enteral nutrient supply for preterm infants: commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2010 Jan;50(1):85-91. doi: 10.1097/MPG.0b013e3181adaee0.

    PubMed 19881390

  • Koletzko B, Goulet O, Hunt J, Krohn K, Shamir R; Parenteral Nutrition Guidelines Working Group; European Society for Clinical Nutrition and Metabolism; European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN); European Society of Paediatric Research (ESPR). 1. Guidelines on Paediatric Parenteral Nutrition of the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and the European Society for Clinical Nutrition and Metabolism (ESPEN), Supported by the European Society of Paediatric Research (ESPR). J Pediatr Gastroenterol Nutr. 2005 Nov;41 Suppl 2:S1-87. doi: 10.1097/01.mpg.0000181841.07090.f4. No abstract available.

    PubMed 16254497

  • Embleton NE, Pang N, Cooke RJ. Postnatal malnutrition and growth retardation: an inevitable consequence of current recommendations in preterm infants? Pediatrics. 2001 Feb;107(2):270-3. doi: 10.1542/peds.107.2.270.

    PubMed 11158457

  • Burattini I, Bellagamba MP, Spagnoli C, D'Ascenzo R, Mazzoni N, Peretti A, Cogo PE, Carnielli VP; Marche Neonatal Network. Targeting 2.5 versus 4 g/kg/day of amino acids for extremely low birth weight infants: a randomized clinical trial. J Pediatr. 2013 Nov;163(5):1278-82.e1. doi: 10.1016/j.jpeds.2013.06.075. Epub 2013 Aug 12.

    PubMed 23941670

  • Bellagamba MP, Carmenati E, D'Ascenzo R, Malatesta M, Spagnoli C, Biagetti C, Burattini I, Carnielli VP. One Extra Gram of Protein to Preterm Infants From Birth to 1800 g: A Single-Blinded Randomized Clinical Trial. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):879-84. doi: 10.1097/MPG.0000000000000989.

    PubMed 26418211

  • Biolo G, Ciocchi B, Stulle M, Piccoli A, Lorenzon S, Dal Mas V, Barazzoni R, Zanetti M, Guarnieri G. Metabolic consequences of physical inactivity. J Ren Nutr. 2005 Jan;15(1):49-53. doi: 10.1053/j.jrn.2004.09.009.

    PubMed 15648007

  • Schulzke SM, Kaempfen S, Trachsel D, Patole SK. Physical activity programs for promoting bone mineralization and growth in preterm infants. Cochrane Database Syst Rev. 2014 Apr 22;2014(4):CD005387. doi: 10.1002/14651858.CD005387.pub3.

    PubMed 24752440

  • Uthaya S, Thomas EL, Hamilton G, Dore CJ, Bell J, Modi N. Altered adiposity after extremely preterm birth. Pediatr Res. 2005 Feb;57(2):211-5. doi: 10.1203/01.PDR.0000148284.58934.1C. Epub 2004 Dec 20.

    PubMed 15611357

  • Prado CM, Heymsfield SB. Lean tissue imaging: a new era for nutritional assessment and intervention. JPEN J Parenter Enteral Nutr. 2014 Nov;38(8):940-53. doi: 10.1177/0148607114550189. Epub 2014 Sep 19.

    PubMed 25239112

  • Betto M, Gaio P, Ferrini I, De Terlizzi F, Zambolin M, Scattolin S, Pasinato A, Verlato G. Assessment of bone health in preterm infants through quantitative ultrasound and biochemical markers. J Matern Fetal Neonatal Med. 2014 Sep;27(13):1343-7. doi: 10.3109/14767058.2013.858317. Epub 2013 Nov 26.

    PubMed 24215624

Questions about this trial

What is this clinical trial studying?

A study testing NUTR + and STIMUL + in people with Infant, Very Low Birth Weight, run by Università Politecnica delle Marche at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Virgilio P. Carnielli, MD, PhD (00390715962045, v.carnielli@univpm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight gain (Birth-36 Weeks PMA) (time frame: birth up to 36 weeks postmenstrual age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03374033, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.

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