Condition category
Pregnancy and Childbirth
Date applied
15/07/2009
Date assigned
04/09/2009
Last edited
17/04/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paola Roggero

ORCID ID

Contact details

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

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

http://www.mangiagalli.it

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

  1. 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.

  2. 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.

Additional files

Editorial Notes