Condition category
Nutritional, Metabolic, Endocrine
Date applied
31/07/2008
Date assigned
05/09/2008
Last edited
05/09/2008
Prospective/Retrospective
Retrospectively 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

Via Commenda 12
Milano
20122
Italy

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 measures

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

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

http://www.mangiagalli.it

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes