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
Secondary identifying numbers N/A
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

Study designSingle centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePost-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 objectivesThe 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) studiedPre-term infant post-discharge nutrition and body composition
InterventionInfants 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 typeOther
Primary outcome measure1. 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 measuresNeurodevelopment 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 study start date15/09/2009
Completion date15/09/2013

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants184
Key inclusion criteria1. 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 criteria1. 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 enrolment15/09/2009
Date of final enrolment15/09/2013

Locations

Countries of recruitment

  • Italy

Study participating centre

Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena
Milan
20122
Italy

Sponsor information

Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena (Italy)
Research organisation

Dipartimento di Scienze Materno-Infantili
Via Commenda 12
Milan
20122
Italy

http://www.mangiagalli.it
ROR logo https://ror.org/016zn0y21

Funders

Funder type

Research organisation

Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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
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