Nutrition, growth and development among very preterm infants - PRENU

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020464-38-NO

Enrollment

240

Registered

2010-05-11

Start date

2010-06-08

Completion date

Unknown

Last updated

2025-03-10

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

Conditions

The main purpose of this study is to evaluate the effect of increased supply of energy, protein, vitamin A and the long chain polyunsaturated fatty acids DHA and AA to Very Low Birth Weight Infants (VLBW,birth weight below 1500 grams) on 1) growth 2)brain maturation 3)cognitive function 4)morbidity such as retinopathy of prematurity, bronchopulmonary dysplasia, periventricular leucomalacia, necrotizing enterocolitis, sepsis. 5)mortality (defined as percent dead before hospital discharge).

Interventions

Trade Name: SMOF lipid Pharmaceutical Form: Emulsion for injection Trade Name: Soluvit Pharmaceutical Form: Powder for infusion* Trade Name: Vitalipid Pharmaceutical Form: Emulsion for infusion Tra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Infants born at Oslo University Hospital and Akershus University Hospital with birth weight =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria are congenital malformations, chromosomal abnormalities and clinical syndromes known to affect growth, and critical illness with short life expectancy.

Design outcomes

Primary

Measure	Time frame
Main Objective: Main hypothesis: By increasing the supply of energy and protein during hospital stay the proportion of VLBW infants discharged from hospital stay as SGA can be reduced from approximately 60 % to less than 40 %. ;Secondary Objective: Secondary hypotheses: 1)Increased nutrient supply will result in improved brain maturation and enlarged anatomical brain structures investigated by MRI at 40 weeks gestational age and 5 months corrected age. 2)Increased nutrient supply will improve cognitive function. 3)Increased nutrient supply will reduce incidence of retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD) (oxygen need at 36 weeks GA), periventricular leucomalacia (PVL), necrotizing enterocolitis (NEC), sepsis and mortality (defined as percent dead before hospital discharge). ;Primary end point(s): Growth and cognitive development	—

Measure

Time frame

Main Objective: Main hypothesis: By increasing the supply of energy and protein during hospital stay the proportion of VLBW infants discharged from hospital stay as SGA can be reduced from approximately 60 % to less than 40 %. ;Secondary Objective: Secondary hypotheses: 1)Increased nutrient supply will result in improved brain maturation and enlarged anatomical brain structures investigated by MRI at 40 weeks gestational age and 5 months corrected age. 2)Increased nutrient supply will improve cognitive function. 3)Increased nutrient supply will reduce incidence of retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD) (oxygen need at 36 weeks GA), periventricular leucomalacia (PVL), necrotizing enterocolitis (NEC), sepsis and mortality (defined as percent dead before hospital discharge). ;Primary end point(s): Growth and cognitive development

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Countries

Norway

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026