Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pre-term infant post-discharge nutrition and body composition
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 measures
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).
Overall trial start date
15/09/2009
Overall trial end date
15/09/2013
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
184
Participant 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
Recruitment start date
15/09/2009
Recruitment end date
15/09/2013
Locations
Countries of recruitment
Italy
Trial participating centre
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena
Milan
20122
Italy
Sponsor information
Organisation
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena (Italy)
Sponsor details
Dipartimento di Scienze Materno-Infantili
Via Commenda 12
Milan
20122
Italy
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23109680
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24645671
Publication citations
-
Results
Roggero P, Giannì ML, Amato O, Liotto N, Morlacchi L, Orsi A, Piemontese P, Taroni F, Morniroli D, Bracco B, Mosca F, Growth and fat-free mass gain in preterm infants after discharge: a randomized controlled trial., Pediatrics, 2012, 130, 5, e1215-21, doi: 10.1542/peds.2012-1193.
-
Results
Giannì ML, Roggero P, Amato O, Picciolini O, Piemontese P, Liotto N, Taroni F, Mosca F, Randomized outcome trial of nutrient-enriched formula and neurodevelopment outcome in preterm infants., BMC Pediatr, 2014, 14, 74, doi: 10.1186/1471-2431-14-74.