Neonatal Diseases Neonatal Diseases
Conditions
Interventions
Suitable babies less that 32+6 weeks gestation who are also of appropriate birth weight for gestational age will be identified by neonatal unit staff. Parent will be approached and explanation of stud
Sponsors
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed parental consent 2. Preterm infants, appropriately grown for gestational age (Child Growth Foundation UK reference), with a gestational age of 32 weeks, whose mother agree to the use of formula if they are unable to or do not wish to breastfeed or are not able to provide sufficient breast milk
Exclusion criteria
Exclusion criteria: 1. More than 72 hours exclusive parenteral nutrition 2. Immediately life-threatening congenital abnormality 3. Any condition requiring major surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of days from birth to establish a total (sole formula or formula with breast milk) daily enteral intake of 150 ml/kg 2. Number of days between birth and 28 days that a total (sole formula or formula with breast milk) daily enteral intake of at least 150 ml/kg is tolerated | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Gain in weight, length and head circumference (change in Z score between birth and 40 weeks postmenstrual age) 2. Faecal flora (colony forming units/g stool of Bifidus sp., Lactobacilli sp., and pathogenic micro-organisms) 3. Faecal calprotectin 4. Stool characteristics 5. Gastrointestinal tolerance 6. Fluid balance (the number of days between trial entry and 28 days where serum sodium exceeds 148 mmol/l or serum creatinine exceeds 150 micromol/l) 7. Proven necrotising enterocolitis according to predefined diagnostic criteria 8. Proven bloodstream infection according to predefined diagnostic criteria | — |
Countries
United Kingdom
Outcome results
None listed