utritional Intervention for Preterm Infants II

Completed

• Conditions: preterm infants; very low birth weight infants; 10028920

• Registration Number: NL-OMON35546
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

Born within the Sophia Children's Hospital
Birth weight less than 1500g
Written informed consent

Exclusion Criteria

Congenital anomalies
Metabolic disease
Endocrine, renal or hepatic disorder

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Nitrogen balance</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety of the nutritional regimen: as reflected by normal blood chemistry, no<br /><br>effect on hearing ability, no effect on chronic lung disease<br /><br><br /><br>Growth: measured in terms of body weight, protein accretion and protein<br /><br>breakdown<br /><br><br /><br>Fatty acid profile in plasma and erythrocytes, plasma phytosterol profile<br /><br><br /><br>Energy expenditure<br /><br><br /><br>Short- and long-term outcome: days on mechanical ventilation, incidence of<br /><br>bronchopulmonary dysplasia, incidence of infection, incidence of<br /><br>intraventricular hemorrhage, incidence of necrotizing enterocolitis, normal<br /><br>ALGO (screening for hearing loss), brain growth and development at 30 and 40<br /><br>and/or 46 weeks gestational age and Bayley III scores (Mental Developmental<br /><br>Index and Psychomotor Developmental Index) at 2 years of age (corrected age for<br /><br>gestational age).</p><br>