Biofilm (colonisation of microorganisms) formation in different types of nasogastric tubes used in preterm neonates

Not Applicable

• Conditions: Biofilm formation in preterm neonates; Neonatal Diseases

• Registration Number: ISRCTN35282497
• Lead Sponsor: South Tees Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-11
• Last Update Posted: 22 November 2021
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Incidence of biofilm formation assessed by microbiological assay for each type of NG tube after it is removed<br> 2. Colony forming units of the bacteria grown during microbiological culture for each type of NG tube after it is removed<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Average gastric pH measured using [method] throughout the duration of NG tube in situ - between 4 to 7 days<br> 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<br>