Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The goal is to evaluate the safety and the effects on neonatal growth and body composition of two distinct strategies (intervention and control) for parenteral nutrition.
Ethics approval
Ethics approval received from the Ethical Committee FONDAZIONE IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena on the 24th March 2006.
Study design
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
Preterm infant nutrition and body composition
Intervention
To detect a difference of 3.0 g/kg per day in weight gain between the two treatment groups (a = 0.25; power = 80%, assuming SD = 2.0 g/kg per day), 9 patients are required for each group.
Preterm infants will be randomised to receive two different schedules of NPT: high or low protein intake for two weeks. The high protein intake consists of at maximum 3.5 g/Kg/d starting from 2.5 g/Kg/d and the low protein intake consists of 2.5 g/Kg/d starting from 1.5 g/Kg/d.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Safety/tolerance:
1. Haemo-gas analysis twice a week for the first 15 days
2. Blood urea nitrogen and serum ammonium on the 1st day of life, on the 4th/5th, on the 7th/8th and 15th day of life
3. Blood amino acid profile on the 1st day of life (before starting NPT) and on the 4th/5th and 15th day of life
Secondary outcome measures
Efficacy:
1. Body composition (assessed by means of deuterium and air plethismography-Pea Pod) at birth, at 15 days of life and at 36 weeks of post-conceptional age
2. Growth (weight assessed daily, length and head circumference assessed weekly)
3. Anabolism assessed by means of nitrogen balance on 2nd, 5th, and 8th day of life
4. Blood amino acid profile on the 1st day of life (before starting NPT) and on the 4th/5th and 15th day of life
Overall trial start date
01/09/2008
Overall trial end date
01/06/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Birth weight between 1000 and 1500 g
2. Being male
3. Being adequate for gestational age (birth weight greater than or equal to 10th percentile according to the Babson and Benda's chart updated)
4. Need for oxygen (O2) less than 40% within the first 72 hours
Participant type
Patient
Age group
Neonate
Gender
Male
Target number of participants
9 patients per group (18 in total)
Participant exclusion criteria
1. Starting parenteral nutrition (NPT) after the first 24 hours of life
2. Chromosomal abnormalities
3. Metabolic disease
4. Congenital infections (toxoplasmosis, rubella, cytomegalovirus, herpes simplex and human immunodeficiency virus [HIV] [TORCH])
5. Score of severity of clinical conditions at birth (CRIBB) greater than 4
Recruitment start date
01/09/2008
Recruitment end date
01/06/2009
Locations
Countries of recruitment
Italy
Trial participating centre
Via Commenda 12
Milano
20122
Italy
Sponsor information
Organisation
Institute of Paediatrics and Neonatology (Italy)
Sponsor details
University Medical School of Milan
Via Commenda 12
Milano
2012
Italy
Sponsor type
Research organisation
Website
Funders
Funder type
Hospital/treatment centre
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
Basic results (scientific)
Publication list