Necrotising enterocolitis, mortality, and cognitive impairment in preterm babies born below 29 weeks gestation Neonatal Diseases
Conditions
Interventions
All interventions and comparators being used in the COLLABORATE trial are currently used as part of routine care in hospitals
no experimental treatments are being tested.
The intervention for randomisation 1 is pasteurised Human Donor Milk (pHDM) when a supplement is needed should there be insufficient milk from their own m
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Randomisation 1: 1. Born <29 weeks gestation 2. No condition precluding enteral feeding 3. Maternal intention to express breast milk 4. The parent has provided verbal consent for the baby to participate in the trial Randomisation 2: 1. Born <29 weeks gestation 2. No condition precluding enteral feeding 3. Maternal intention to express breast milk 4. The parent has provided verbal consent for the baby to participate in the trial Mechanistic study: 1. Participants in randomisation 1 recruited at the Royal Infirmary of Edinburgh 2. Written informed consent for the mechanistic study
Exclusion criteria
Exclusion criteria: Randomisation 1: 1. Baby has already received pHDM, Preterm Formula Randomisation 2: 1. Baby has already received Fortifier Mechanistic study: 1. Infants with congenital anomalies: structural or functional anomalies (e.g., metabolic disorders) that occur during intrauterine life and can be identified prenatally, at birth or later in life (WHO definition) 2. Infants with a contraindication to MRI at 3 Tesla
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival at 34 weeks postmenstrual age without surgical NEC, assessed from data held in the UK National Neonatal Research Database | — |
Secondary
| Measure | Time frame |
|---|---|
| All outcomes are assessed from data held in the UK National Neonatal Research Database unless otherwise stated. The following outcomes are assessed at 34 weeks postmenstrual age: 1. Survival 2. Surgical NEC 3. Spontaneous Intestinal Perforation The following outcomes are assessed at 36 weeks postmenstrual age: 1. Bronchopulmonary dysplasia The following outcomes are assessed at postnatal age 28 days: 1. Survival The following outcomes are assessed at neonatal unit discharge (or death): 1. Survival 2. Surgery for NEC or NEC-related condition after 34 weeks postmenstrual age 3. Medical NEC 4. Age in days to achieve an enteral intake of 150 ml/kg/day 5. Treated retinopathy of prematurity 6. Severe brain injury 7. Any diagnosis of milk-curd obstruction 8. Length of neonatal unit stay 9. Number of episodes of bacterial or fungal bloodstream infection 10. Number of episodes of bacterial or fungal cerebrospinal fluid infection 11. Number of episodes of bacterial or fungal urinary tract infection 12. Number of days of antibiotic treatment 13. Number of days on parenteral nutrition 14. Number of days nil by mouth 15. Weight, length, and head circumference Z-scores 16. Change from birth in Z-scores for weight, length, and head circumference 17. Any breastfeeding (suckling at breast) 18. Exclusive breastfeeding (suckling at breast) 19. Receiving any expressed Own Mother’s Milk 20. Receiving exclusive expressed Own Mother’s Milk 21. Maximum serum urea, creatine, and alkaline phosphatase 22. Health resource use The following outcomes are assessed at neonatal unit discharge (or death) in babies with NEC surgery: 1. Drain insertion prior to surgery (yes/no) 2. Diagnosis of short bowel syndrome (yes/no) 3. Diagnosis of intestinal failure-associated liver disease (yes/no) 4. Length of bowel resected (cm) 5. Primary surgical procedure (ileostomy; colostomy; end-to-end anastomosis) 6. Number of re-operations (excluding primary operation) The following outcomes are assess | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed