Biofilm formation in preterm neonates Neonatal Diseases
Conditions
Interventions
Randomisation:
Minimisation using gestation (<30+0 weeks) yes/no. Twins and triplets will be allocated to the same study arm. Secured, password-protected web-based randomisation using
some babies will be in the study for longer if the NG tube dislodged or had to be taken out due to clinical reasons before 4 days (presumed time period for possible biofilm formation based on the prel
Sponsors
South Tees Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Stable preterm infants born between 27+0 to 31+6 weeks gestation 2. Tolerating at least 48 ml/kg/day of enteral milk feed (chosen due to local preterm feeding protocol) 3. The clinical need for nasogastric tube insertion 4. Written informed consent from parents
Exclusion criteria
Exclusion criteria: 1. No informed consent available 2. Not tolerating =50 ml/kg/day of enteral feeds 3. Known congenital anomaly or surgical condition of the GI tract
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of biofilm formation assessed by microbiological assay for each type of NG tube after it is removed 2. Colony forming units of the bacteria grown during microbiological culture for each type of NG tube after it is removed | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Average gastric pH measured using [method] throughout the duration of NG tube in situ - between 4 to 7 days 2. The incidence of feed intolerance (nil by mouth, bilious aspirates, vomiting), measured using [method] for the duration of NG tube in situ - between 4 to 7 days | — |
Countries
England, United Kingdom
Outcome results
None listed