Digestive health of preterm infants Neonatal Diseases
Conditions
Interventions
All mothers are encouraged and supported to provide as much of their own breast milk ('Mothers Own Milk', MOM) as they wish to. When there is insufficient MOM to meet the infants needs this is called
Sponsors
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 11/03/2021: 1. Preterm infants born below 30 completed weeks of gestation (<=29 weeks and 6 days) 2. Written informed consent from parents 3. Has not received any milk other than MOM Previous inclusion criteria: 1. Preterm infants born below 29 completed weeks of gestation (<=28 weeks and 6 days) 2. Written informed consent from parents 3. Has not received any milk other than MOM
Exclusion criteria
Exclusion criteria: 1. Major congenital or life threatening abnormalities 2. Inability to randomise within 48 hours of birth 3. Exposure to bovine milk product prior to randomisation 4. Likelihood of transfer to another hospital before 34 weeks postmenstrual age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Gut microbiota bacterial diversity and proportions of specific taxa. Stool samples are collected daily and measured on =2 occasions between enrolment until trial completion (days 10-12 full feeds) and day 28 3. Body composition by assessing adipose tissue mass and non-adipose tissue mass using whole body magnetic resonance imaging (MRI) at term (37-42 weeks postmenstrual age) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Feeding related outcomes: total number of days on which feeds were withheld on any occasion after trial enrolment; age when enteral feeds =150ml/kg/day maintained for at least 3 days (coded as first day achieved); total days exposed to MOM prior to 34 weeks; feeding mode at discharge (breast, formula or mixed). Measured once using clinical records and recorded prior to hospital discharge. 2. Healthcare resource use: total length of stay (days); postmenstrual age at discharge; days in intensive, high-dependency and low-dependency care according to national definitions (BAPM), recorded once at discharge using medical records 3. Survival to discharge; Retinopathy of Prematurity, maximum stage and intervention; Necrotising Enterocolitis requiring surgery or leading to death; blood-culture positive sepsis; total days when any antibiotic administered; chronic lung disease (oxygen requirement or need for any pressure support at 36 weeks postmenstrual age), peri-ventricular haemorrhage (PVH) and/or presence of parenchymal damage. These will all be determined using established national definitions (National Neonatal Audit Programme), and informed using recently completed studies on NEC and agreed by investigator end-point review committee. Measured using clinical records and total morbidities confirmed prior to hospital discharge. 4. Growth and body composition including adipose tissue volume and distribution (MRI at 37-42 weeks gestation) and weight, head circumference and length measured on a weekly basis from enrolment to discharge | — |
Countries
England, United Kingdom
Outcome results
None listed