Prematurity
Conditions
Interventions
Product Name: Standardised concentrated neonatal parenteral nutrition MAX
Product Code: scNPNmax
Pharmaceutical Form: Intravenous infusion
INN or Propos
Sponsors
Liverpool Women's NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: All infants born under 29 weeks gestation and weighing =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Infants born in very poor condition in first 72 hours and are unlikely to survive the first week after birth. Infants born <24 weeks gestation. Infants diagnosed with major congenital or chromosomal abnormalities know to affect head growth or gastrointestinal function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare early head growth in premature infants (< 29 weeks gestation) receiving a standardised concentrated neonatal parenteral nutrition (scNPN) formulation with scNPN containing additional macronutrients: protein, fat and carbohydrate (scNPNmax).; Secondary Objective: Secondary outcomes compare scNPNmax and scNPN with respect to: 1) other growth measurements (weight gain, lower leg length) up to the age of 36 weeks gestation 2) efficiency and safety of parenteral nutrition administration 3) effects on routine monitoring of body biochemistry, nutrients in the circulation and markers of infection (sometimes referred to as NPN tolerance) 4) supplementary biochemical (electrolyte) infusion requirements 5) use of other drugs and infusions 6) use and non-infective complications of intravenous lines 7) cost 8) neurodevelopmental outcome in survivors at 18 months corrected age ;Primary end point(s): Change in head circumference over the first 28 days of life. | — |
Countries
United Kingdom
Outcome results
None listed