Nutrition in preterm infants Pregnancy and Childbirth
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Preterm infants born at less than 33 completed weeks of gestation or less than 1500 g birthweight 2. Admitted to Ward 35 (Neonatal Unit, RVI) in first week of life 3. Written informed consent from parents 4. Maternal intention to provide breastmilk after birth
Exclusion criteria
Exclusion criteria: 1. Parents unwilling to accept donor human milk 2. Major congenital or life-threatening abnormalities 3. Inability to randomise within 7 days of birth 4. Exposure to formula milk product prior to randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Breastfeeding (or a mother who is still expressing breastmilk) at 36 completed weeks of gestation or discharge if this is earlier (yes/no) measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using patient records unless otherwise stated: 1. Growth – measured weekly: weight, length, head circumference, MUAC and MTC: absolute changes (g/kg/day and mm/week) and change in standard deviation score 2. Episodes of NEC, sepsis - confirmed and clinically suspected according to existing case definitions 3. Chronic lung disease, Retinopathy of prematurity (ROP), intraventricular haemorrhage, Cystic periventricular leukomalacia (PVL) - confirmed using existing case definitions 4. Days of intensive, high and low dependency care; age at discharge, total length of stay 5. Total volume (litres) of milk (MOM, DHM and formula) received from birth to 36 weeks 6. Age at starting a fortifier 7. Type of feeding at discharge (direct breast feeding, tube feeding etc.) 8. Maternal breastfeeding self-efficacy measured using Breastfeeding self-efficacy short form (BSE-SF), Edinburgh Postnatal Depressions Score and thematic analysis of qualitative interviews in a subset of up to 20 mothers between 5-10 days of age and again at 35-36 week of corrected gestation or prior to discharge if sooner | — |
Countries
England, United Kingdom