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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Via Commenda 12
Milano
20122
Italy
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/09/2008 |
| Completion date | 01/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Male |
| Target number of participants | 9 patients per group (18 in total) |
| 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
20122
Italy
Sponsor information
Institute of Paediatrics and Neonatology (Italy)
Research organisation
Research organisation
University Medical School of Milan
Via Commenda 12
Milano
2012
Italy
| Website | http://www.mangiagalli.it |
|---|---|
"ROR" |
https://ror.org/00wjc7c48 |
Funders
Funder type
Hospital/treatment centre
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
