Head growth in very preterm infants Neonatal Diseases Disorders related to short gestation and low birth weight, not elsewhere classified
Conditions
Interventions
Informed consent and randomisation to the trial. Intravenous administration of either scNPN (standard) or scNPNmax (study) solution. Daily collection of routine biochemical monitoring data and all or
Sponsors
Liverpool Women's Hospital NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All infants (both males ane females) born less than 29 weeks gestation and weighing <1,200 grams born at Liverpool Women's Hospital (LWH) will be eligible. All infants meeting these criteria born outside LWH will be eligible if transfer takes place to LWH within 48 hours.
Exclusion criteria
Exclusion criteria: 1. Infants born in poor condition in the first 72 hours and are unlikely to survive the first week after birth 2. Infants diagnosed with major congenital and chromosomal abnormalities know to affect head growth or gastrointestinal function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare early head growth in premature infants receiving a standardised formulation of parenteral nutrition(scNPN) with a standardised, concentrated formulation of parenteral nutrition containing additional protein, fat and carbohydrate (scNPNmax). Timepoints: when the infant is 28 days old (having already had growth measurements on days 0, 7, 14 and 21). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Weight gain and linear growth 2. Monitoring supplementary infusion requirements such as insulin and electrolytes 3. Routine biochemical measures of PN tolerance 4. Cost-benefit analysis 5. Efficiency and safety of prescribing and administration 6. Neurodevelopmental outcome (Bayley III) Timepoints: For outcomes 1 - 5: At 28 days and 36 weeks post conceptual age For outcome 6: At 18 months corrected for gestational age | — |
Countries
England, United Kingdom
Outcome results
None listed