NCT03374033

Brief 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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 15, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2020

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

3 years

First QC Date

November 13, 2017

Last Update Submit

May 7, 2019

Conditions

Infant, Very Low Birth Weight

Keywords

Preterm infants, growth, nutrition, physical activity

Outcome Measures

Primary Outcomes (1)

  • Weight gain (Birth-36 Weeks PMA)

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

    birth up to 36 weeks postmenstrual age

Secondary Outcomes (22)

  • Muscle ultrasound

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

  • Adipose tissue ultrasound

    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

    36 weeks postmenstrual age (+-1d )

  • Skinfold thickness

    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

    40 weeks postmenstrual age (+-1d )

  • +17 more secondary outcomes

Study Arms (4)

NUTR (Nutrition) 0_STIMUL(Stimulation) 0

NO INTERVENTION

Standard Nutrition and no Physical Stimulation

NUTR 0_STIMUL +

EXPERIMENTAL

Standard Nutrition and Physical Stimulation

Behavioral: STIMUL +

NUTR +_STIMUL 0

EXPERIMENTAL

Enhanced Nutrition, and no Physical Stimulation

Dietary Supplement: NUTR +

NUTR +_STIMUL +

EXPERIMENTAL

Enhanced Nutrition and Physical Stimulation

Dietary Supplement: NUTR +Behavioral: STIMUL +

Interventions

NUTR +DIETARY_SUPPLEMENT

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

NUTR +_STIMUL +NUTR +_STIMUL 0
STIMUL +BEHAVIORAL

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

NUTR +_STIMUL +NUTR 0_STIMUL +

Eligibility Criteria

Age24 Weeks - 32 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale G. Salesi

Ancona, 60123, Italy

RECRUITING

Related Publications (10)

  • 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.

    PMID: 19881390BACKGROUND

  • 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.

    PMID: 16254497BACKGROUND

  • 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.

    PMID: 11158457BACKGROUND

  • 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.

    PMID: 23941670BACKGROUND

  • 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.

    PMID: 26418211BACKGROUND

  • 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.

    PMID: 15648007BACKGROUND

  • 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.

    PMID: 24752440BACKGROUND

  • 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.

    PMID: 15611357RESULT

  • 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.

    PMID: 25239112RESULT

  • 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.

    PMID: 24215624RESULT

MeSH Terms

Conditions

Motor Activity

Interventions

NutR protein, bacteriophage lambda

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Virgilio P. Carnielli, MD, PhD

    Università Politecnica delle Marche

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Virgilio P. Carnielli, MD, PhD

CONTACT

00390715962045v.carnielli@univpm.it

Chiara Biagetti, MD

CONTACT

00390715962014chiara.biagetti@ospedaliriuniti.marche.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Neonatology Department

Study Record Dates

First Submitted

November 13, 2017

First Posted

December 15, 2017

Study Start

April 10, 2017

Primary Completion

April 3, 2020

Study Completion

July 30, 2022

Last Updated

May 9, 2019

Record last verified: 2019-05

Locations

IT(1)