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Nutritional Intervention for Preterm Infants II

Nutritional Intervention for Preterm Infants II - NIPI II

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35546
Enrollment
240
Registered
2008-12-11
Start date
2008-12-22
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

preterm infants very low birth weight infants

Interventions

The intervention group 1 will receive lipids from birth onwards. Intervention group 2 will receive extra amino acids in combination with lipids from birth onwards. The control group will be fed acco

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Congenital anomalies Metabolic disease Endocrine, renal or hepatic disorder

Design outcomes

Primary

MeasureTime frame
Nitrogen balance

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)