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	https://doi.org/10.1186/ISRCTN30189842
Protocol serial number	N/A
Sponsor	Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena (Italy)
Funder	Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena (Italy)

Submission date: 15/07/2009
Registration date: 04/09/2009
Last edited: 17/04/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Paola Roggero
Scientific

Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena
University Medical School of Milan
Via Commenda 12
Milan
20122
Italy

Study information

Primary study design	Interventional
Study design	Single centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Ethical Committee FONDAZIONE IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena approved on the 7th July 2009
Health condition(s) or problem(s) studied	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
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)
Key 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).
Completion date	15/09/2013

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	184
Key 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
Key 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
Date of first enrolment	15/09/2009
Date of final enrolment	15/09/2013

Locations

Countries of recruitment

Italy

Study participating centre

Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena

Milan
20122
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2012		Yes	No
Results article	results	19/03/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes