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Post-discharge growth, body composition and neurodevelopment outcome of very preterm infants in relation to two formulas with different composition in terms of energy and protein content
ISRCTN ISRCTN30189842
DOI 10.1186/ISRCTN30189842
ClinicalTrials.gov identifier
EudraCT number
Public title Post-discharge growth, body composition and neurodevelopment outcome of very preterm infants in relation to two formulas with different composition in terms of energy and protein content
Scientific title Post-hospital discharge feeding for very preterm infants: effects of standard compared with enriched milk formula on growth, body composition and neurodevelopment outcome - a single centre randomised controlled trial
Acronym N/A
Serial number at source N/A
Study hypothesis The goal is to evaluate the effects on post-discharge growth, body composition and neurodevelopment outcome of two distinct strategies for post-discharge nutrition.
Lay summary Not provided at time of registration
Ethics approval Ethical Committee FONDAZIONE IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena approved on the 7th July 2009
Study design Single centre randomised controlled trial
Countries of recruitment Italy
Disease/condition/study domain Pre-term infant post-discharge nutrition and body composition
Participants - inclusion criteria 1. Birth weight less than 1500 g
2. Gestational age less than 33 weeks
3. Caucasian race, either sex
4. Informed consent signed by infants' parents or legal guardian
Participants - exclusion criteria 1. Congenital diseases
2. Chromosomal abnormalities
3. Severe gastrointestinal diseases (i.e. necrotising enterocolitis)
3. Metabolic and or endocrine disease
4. Severe brain injury
5. Chronic lung disease
Anticipated start date 15/09/2009
Anticipated end date 15/09/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 184
Interventions Infants will be enrolled at term equivalent age and will be prospectively followed-up from term to 12 months of corrected age.

At term equivalent age infants will be randomised in four groups:
Group 1: infants born average for gestational age (AGA) fed nutrient-enriched post-discharge formula (2.2 g/100 ml; 75 kcal/100 ml)
Group 2: infants born AGA fed standard formula (1.4 g/100 ml; 67 kcal/100 ml)
Group 3: infants born small for gestational age (SGA) fed nutrient-enriched post-discharge formula (2.2 g/100 ml; 75 kcal/100 ml)
Group 4: infants born SGA fed standard formula (1.4 g/100 ml; 67 kcal/100 ml)

From term up to the six month, infants will be fed a nutrient-enriched post-discharge or standard formula (according to randomisation) on demand and will be given no other foods. Parents will be instructed to record the daily quantities of milk consumed by the infants in a diary. The average daily energy and protein intakes (expressed as kcal/kg body weight/d and g/kg body weight/d, respectively) will be calculated at each study visit time.

Infants will enter a follow-up program that consists of assessment of periodic growth and body composition assessments (by means of an air displacement plethysmography system and the four skinfold thicknesses [triceps, biceps, subscapular and suprailiac], with use of a skinfold calliper) at term corrected age, 15 d, 1, 3, 5, 6 and 12 months of corrected age. Neurodevelopmental outcome will be also assessed by means of a neurofunctional evaluation (at 40 weeks, 3, 6, 12 months' corrected age) and the Griffith Scale (at 12 months of corrected age).

Reference group:
The reference group will be represented by infants fed human milk who will not be randomised but will undergo the growth, body composition and neurodevelopment assessment according to the protocol.

In order to detect a 5% difference in fat mass among groups at a significance level of 0.05 and 80% power, 40 infants are needed for each group. Taking into account lost-to-follow up/withdrawal, a total number of 160 will need to be recruited for the study. Taking into account lost-to-follow up/withdrawal, a total number of 184 will need to be recruited for the study.
Primary outcome measure(s) 1. Body composition (assessed by means of an air plethismography-Pea Pod and the four skinfold thicknesses [triceps, biceps, subscapular and suprailiac] with use of a skinfold calliper), at term corrected age, 15 d, 1, 3, 5, 6 and 12 months of corrected age
2. Growth (weight, length and head circumference assessed at term corrected age, 15 d, 1, 3, 5, 6 and 12 months of corrected age)
Secondary outcome measure(s) Neurodevelopment outcome (by means of a neurofunctional evaluation at 40 weeks, 3, 6, 12 months' corrected age) and the Griffith Scale (at 12 months of corrected age).
Sources of funding Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena (Italy)
Trial website
Publications 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23109680
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24645671
Contact name Prof  Paola  Roggero
  Address Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena
University Medical School of Milan
Via Commenda 12
  City/town Milan
  Zip/Postcode 20122
  Country Italy
Sponsor Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena (Italy)
  Address Dipartimento di Scienze Materno-Infantili
Via Commenda 12
  City/town Milan
  Zip/Postcode 20122
  Country Italy
  Sponsor website: http://www.mangiagalli.it
Date applied 15/07/2009
Last edited 17/04/2014
Date ISRCTN assigned 04/09/2009
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