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

Completed

• Conditions: Nutritional, Metabolic, Endocrine; Preterm infant nutrition and body composition; Preterm infant nutrition

• Registration Number: ISRCTN99801051
• Lead Sponsor: Institute of Paediatrics and Neonatology (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 18

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety/tolerance:<br>1. Haemo-gas analysis twice a week for the first 15 days<br>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<br>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

Name	Time	Method
Efficacy:<br>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<br>2. Growth (weight assessed daily, length and head circumference assessed weekly)<br>3. Anabolism assessed by means of nitrogen balance on 2nd, 5th, and 8th day of life<br>4. Blood amino acid profile on the 1st day of life (before starting NPT) and on the 4th/5th and 15th day of life