Preterm infant nutrition and body composition Nutritional, Metabolic, Endocrine Preterm infant nutrition
Conditions
Interventions
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
Sponsors
Institute of Paediatrics and Neonatology (Italy)
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed