Assessment of growth and body composition in preterm infants in relation to two different protein intakes: a randomised controlled trial

ISRCTN	ISRCTN99801051
DOI	https://doi.org/10.1186/ISRCTN99801051
Protocol serial number	N/A
Sponsor	Institute of Paediatrics and Neonatology (Italy)
Funder	Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena (Italy)

Submission date: 31/07/2008
Registration date: 05/09/2008
Last edited: 05/09/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Paola Roggero
Scientific

Via Commenda 12
Milano
20122
Italy

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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(s)	Ethics approval received from the Ethical Committee FONDAZIONE IRCCS Ospedale Maggiore Policlinico Mangiagalli Regina Elena on the 24th March 2006.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/06/2009

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Male
Target sample size at registration	18
Key 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
Key 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
Date of first enrolment	01/09/2008
Date of final enrolment	01/06/2009

Locations

Countries of recruitment

Italy

Study participating centre

Via Commenda 12

Milano
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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes