Neonatal nutrition Neonatal Diseases Neonatal nutrition
Conditions
Interventions
Mothers will be randomised in a 1:1 ratio, for their infants to receive either:
1. Intervention – infant(s) started on full milk feeds (a minimum of 60ml per kg of the baby’s weight each day) from day
Sponsors
University Hospitals of Derby and Burton NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Infant born at 30 weeks + 0 days to 32 weeks + 6 days gestation, inclusive 2. Infant <3 hours (180 minutes) old (since recorded time of birth) (Infants requiring respiratory support (such as via continuous positive airway pressure) or other supportive treatments will be included in the study if the attending clinician is in equipoise about the infant being randomised to either the “full milk” or the “gradual milk” arm. Similarly, well infants should only be included if the attending clinician is in equipoise about the best feeding regime and the infant being randomised to either “full milk” or “gradual milk” groups.)
Exclusion criteria
Exclusion criteria: 1. Infant with known congenital abnormalities of the gastrointestinal tract or other congenital conditions that make enteral feeding unsafe 2. Infant who are small for gestational age (birth weight <10th centile) AND evidence of reversed end-diastolic flow on antenatal umbilical artery Doppler ultrasound* 3. Mother has participated in the trial during a previous pregnancy# *Small for gestational age infants with antenatal Doppler ultrasound scan showing absent umbilical artery flow or whose mother’s did not have antenatal umbilical Doppler ultrasound may be eligible for the trial if they meet the other inclusion criteria. #The trial will recruit over 36 months. It is possible that the mother of an infant(s) who has already participated in the trial has another pregnancy in this duration. In such circumstances, the infant(s) born in subsequent pregnancies will be excluded to avoid bias due to the experience of previous participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of hospital stay | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Survival to hospital discharge 2. Survival to 6 weeks corrected gestational age (i.e. term gestation + 6 weeks) 3. Incidence of microbiologically-confirmed (positive blood/cerebrospinal fluid [CSF] culture) or clinically suspected (defined by diagnostic criteria) late-onset sepsis until hospital discharge 4. Necrotising enterocolitis (Bell’s stage 2 or 3) until hospital discharge 5. Time taken to maintain full milk feeding (defined as at least 140 ml/kg/d for three consecutive days) 6. Time to regain birth weight 7. Growth (z scores for gestational age at hospital discharge (as per UK-NICM growth charts)) 7.1 Weight in kg 7.2 Length in cm 7.3 Head circumference in cm 8. Breastfeeding at hospital discharge 9. Breast milk fed at hospital discharge 10. Number of days of peripheral cannula until full milk feeding (defined as at least 140 ml/kg/d for three consecutive days) achieved 11. Number of IV cannulae inserted until full milk feeding (defined as at least 140 ml/kg/d for three consecutive days) achieved 12. Number of days of parenteral nutrition, until hospital discharge 13. Number of central venous lines inserted (including umbilical and percutaneous or surgically inserted venous lines) until hospital discharge 14. Number of central line days until hospital discharge 15. Time until objective discharge criteria are met 16. Hospital visits (including day care and overnight admissions) up to 6 weeks of corrected age (i.e. term gestation + 6 weeks) 17. Breast feeding at 6 weeks of corrected age (i.e. term gestation + 6 weeks) 18. Breast milk fed at 6 weeks of corrected age (i.e. term gestation + 6 weeks) 19. Parental satisfaction and wellbeing at 6 weeks of corrected age (i.e. term gestation + 6 weeks), using the Preterm Birth Experience and Satisfaction Scale (p-BESS) questionnaire | — |
Countries
England, United Kingdom
Contacts
Public ContactGarry Meakin
Outcome results
None listed