Clinical trial NCT02830503: Feeding Tube Practices and Colonization of the Preterm Stomach in the First Week of Life
Official title: Feeding Tube Practices and Colonization of the Preterm Stomach in the First Week of Life: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Statens Serum Institut
First posted: 2016-07-13
Enrollment: 23
Sex: ALL
Minimum age (years): 1
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Project summary

Rationale

Many NICU's replace their feeding tubes once a week or more rarely in order to avoid disturbing the infants. The researchers discovered that there are high concentrations of potentially pathogenic bacteria in the yield of resident nasogastric feeding tubes, even within one day of use (own data, manuscript submitted). Preterm infants are vulnerable to the colonization of the gut, and development of dysbiosis might lead to necrotizing enterocolitis. The researchers speculate if replacing the resident feeding tube every day and thereby decreasing the amount of potentially pathogenic bacteria given to the infants via the feeding tube will lead to fewer bacteria present in the upper part of the gastrointestinal tract of the infant and hence a reduced competition with probiotic colonization.

Objectives

The investigators plan to conduct an intervention study in premature infants receiving probiotics (\< 32 weeks of gestation) where the feeding tube will be replaced every day in the intervention group and once a week (standard practice) in the control group. The main outcome will be bacterial concentration in the stomach after one week of life.

Methods

The study is a prospective, randomized controlled trial in preterm infants. Infants will be randomized to the intervention group in which the tube is replaced every day or the control group which will follow normal practice in the department. The intervention will last one week. The infants will be followed until discharge. The investigators plan to include 11 infants in each group.

Primary outcome

Concentration of bacteria in gastric aspirates on day seven.


Eligibility criteria: Inclusion Criteria:

* Under 32 weeks GA at birth
* Admission time considered to be more than seven days
* Signed informed consent within 48 hours after birth

Exclusion Criteria:

* Transfer to another hospital within seven days
* Major gastrointestinal malformations
* No tube feeding within first 48 h of birth

Primary outcomes:
measure: Concentration (CFU/ml) of bacteria in gastric aspirates
timeFrame: on day seven of life
Secondary outcomes:
measure: Number of patients with potentially pathogenic bacteria at any concentration in gastric aspirates
timeFrame: day seven of life.
measure: pH (acidity) of gastric aspirates
timeFrame: First week of life
measure: Number of patients with probiotics cultured from gastric aspirates aspirates
timeFrame: First week of life
measure: Concentration (CFU/ml) of bacteria in maternal milk
timeFrame: First week of life
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Neonatology, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Gorm Greisen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munkstrup C, Krogfelt KA, Greisen G, Juhl SM. Feeding tube practices and the colonisation of the preterm stomach in the first week of life. Dan Med J. 2022 Jul 13;69(8):A06210494.