Neurodevelopmental outcomes Neonatal Diseases Neurodevelopmental outcomes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Day 1 to 4 of life 2. Less than 1500 g birth weight 3. Enteral feeding is expected to be initiated in the first 7 days of life
Exclusion criteria
Exclusion criteria: 1. Infants with serious congenital or chromosomal anomalies that may contribute to serious developmental outcome 2. Asphyxia (hypoxia or ischaemia) as defined by all of: 2.1. Severe metabolic or mixed acidaemia (pH less than 7.00 or base deficit less than -16) on an umbilical cord arterial blood sample or neonatal blood gas within first hour of life 2.2. Apgar score of 0 - 3 for greater than 5 minutes 2.3. Multi-organ system dysfunction within 72 hours of birth 3. Enrolment in any other clinical study affecting nutritional management during the feeding intervention 4. Reasonable potential that the infant will be transferred to a Neonatal Intensive Care Unit (NICU) or Level II NICU where the study protocol will not be continued
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive composite score on the Bayley Scales of Infant and Toddler Development-III (BSID-III) at 18 - 24 months corrected age. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Morbidity/mortality 2. Composite of death, NEC, late onset sepsis, chronic lung disease or severe retinopathy of prematurity (ROP) 3. Growth (Secondary): 3.1. Weight (g/kg/d), length (mm/wk) and head circumference (mm/wk) gain 3.2. Weight-for-age, length-for-age and head circumference-for-age z-scores 4. Development (Secondary): 4.1. Language and motor composite scores on the BSID-III at 18-24 months corrected age 5. Feeding Tolerance and Nutrient Intake (Exploratory) 5.1. Days to full enteral feeding (150 ml/kg/d) 5.2. Days feedings withheld 5.7. Estimated energy and select nutrient intakes (protein, fat, calcium, phosphorus, iron, zinc) 6. Growth and Breastfeeding (Exploratory) 6.1. Weight-for-age, length-for-age and head circumference-for-age z-scores to 18-24 months corrected age 6.2. Duration (days) of human milk feeding (mothers? own milk) 6.3. Exclusivity of human milk feeding (mothers? own milk) at each infant?s 4, 6 and 12 months corrected age 7. Cost effectiveness (medical and non-medical) from a societal perspective (Exploratory) Added 20/09/2017: 8. Gut microbiome characterization (Exploratory | — |
Countries
Canada