Early Nutrition Study.

Recruiting

• Conditions: Prematurity; donor milk; very low birth weight infant; late onset sepsis; necrotizing enterocolitis; infant formula; breast milk

• Registration Number: NL-OMON24223
• Lead Sponsor: VU Medical Center, Amsterdam, the Netherlands

Brief Summary

n/a

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 396

Inclusion Criteria

1. Birth weight < 1500 gram;

2. Written informed consent.

Exclusion Criteria

1. Child of mother that abused drugs and/or alcohol during pregnancy;

2. Major congenital anomalies or birth defects;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of the combined outcome of serious late-onset infections (sepsis/ meningitis and NEC) and/ or death occurring between age 72 hours and 60 days.<br><br>1. Early Supplementation study Amendment (applicable in St. Radboud UMC Nijmegen (RUNMC) en VUmc Amsterdam)<br>- Primary Outcome: bone mineral content (BMC) and body composition measured by DXA<br><br>2. Adrenocortical function amendment (applicable in VUmc)<br>- Primary Outcome: Urinary cortisol metabolites at days 10 and 30.<br><br>3. Body Composition amendment (applicable in VUmc and AMC Amsterdam)<br>- Primary Outcome: Body composition (body fat%, fat-free mass, lean mass, fat mass, fat-free mass index, fat mass index) and growth at 1, 2 and 5 years of age.