InfectionNCT03728608

Optimal Feeding Tube Dwell Time in VLBW Infants to Reduce Feeding Tube Contamination

A study testing Feeding tube dwell time of 48 hours and Feeding tube dwell time of 7 day in people with Infection, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The study team will determine whether a decreased feeding tube dwell time will reduce feeding tube contamination Read more about this study

Who is it for?: Ages 30 to 40 weeks
Conditions the study is for: Infection
What is being tested?: Feeding tube dwell time of 48 hours and Feeding tube dwell time of 7 day
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 151 participants
Where: 1 siteUnited States
Study dates: 10 May 2017to 31 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 40 weeks
All sexes
No healthy volunteers
Child

Who may be able to join

be born to a mother who is at least 18 years of age and English or Spanish speaking
born at < or equal to 30 weeks
have a birthweight < or equal to 1500 grams
be born to a mother who is COVID Negative
have a feeding tube placed within 24 hours of birth
be expected to require a feeding tube for 4 weeks following birth.

Who cannot join

infant with known congenital GI anomalies
infants which are not expected to live
infants will be withdrawn from the study if they require abdominal surgery for GI morbidities

Trial locations and contacts

1 site in 1 country.

United States1 site

Unversity of Florida
Gainesville, Florida, 32611

Other trials in United States

About this study

The study team will determine whether a decreased feeding tube dwell time will reduce feeding tube contamination

Read the detailed description

Contaminated feeding tubes can occur in the neonatal intensive care unit (NICU) and have been associated with significant morbidity. Due to an immature immunologic systems, premature infants are at significant risk of complications related to contaminated feeding tubes. Feeding tube dwell time may affect the level of contamination. This study will determine if a maximum feeding tube dwell time of 48 hours reduces contamination compared to a maximum feeding tube dwell time of 7 days, thereby improving neonatal health outcomes.

Conditions: Infection
Being tested: Feeding tube dwell time of 48 hours, Feeding tube dwell time of 7 day
Keywords: neonatal intensive care unit (NICU), feeding tube contamination
Medical subject headings: Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Feeding tube dwell time of 48 hoursDevice
Feeding tube dwell time of 48 hours for first 4 weeks of life.
Feeding tube dwell time of 7 dayDevice
Feeding tube dwell time of 7 days for first 4 weeks of life.

Study groups in NCT03728608
Study group	Role	What they receive
Group 1--Short Dwell	Active comparator	Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 0-48 hours for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination. Receives: Device: Feeding tube dwell time of 48 hours
Group 2--Long Dwell	Active comparator	Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 7 days for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination. Receives: Device: Feeding tube dwell time of 7 day

What is being measured

The primary outcome is the main question the study is designed to answer.

Amount of Contamination
prepared solution of sectioned feeding tubes will be plated on Agar. After 24 hrs of incubation, unique colony types will be counted.
Measured: 24 hours

Secondary outcomes (10)

Gastrointestinal Inflammation - S100A12
The samples will be analyzed for inflammatory markers using S100A12. Values will be log10 transformed
Measured: 4 weeks
Gastrointestinal Inflammation - Calprotectin
The samples will be analyzed for inflammatory markers using calprotectin immunoassays. Levels will be log10 transformed
Measured: 4 weeks
Hours of Parenteral Nutrition
Measured: 4 weeks
Days With a Central Venous Line
Measured: 4 weeks
Length of Neonatal Intensive Care Stay
Measured: birth until discharge from the neonatal intensive care unit
Days to Reach Full Feeds
Measured: 4 weeks
Number of Infants With Necrotizing Enterocolitis
Measured: 4 weeks
Number of Infants With Late Onset Sepsis
Measured: 4 weeks
Episodes of Abdominal Distension
Measured: 4 weeks
Number of Infants With a Direct Bilirubin > 2 mg/dL
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 May 201731 May 2023

First posted2 Nov 2018
Study start10 May 2017
Primary completion2 Feb 2023
Study completion31 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InfectionStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03728608
Sponsor's protocol ID: IRB201700398 -N-A
Other IDs: R01NR016964-01A1, 5KL2TR001429, 5R01NR016964-04
Status last verified: Jan 2025
First submitted: 24 Oct 2018
Last updated: 3 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19

All Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimal Feeding Tube Dwell Time in VLBW Infants to Reduce Feeding Tube Contamination
ClinicalTrials.gov ID: NCT03728608
Acronym / sponsor ID: IRB201700398 -N-A
Conditions: Infection
Keywords: neonatal intensive care unit (NICU), feeding tube contamination
Study type: Interventional
Recruitment status: Completed
Enrolment: 151 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: National Institute of Nursing Research (NINR), National Center for Advancing Translational Sciences (NCATS)
Study start: 10 May 2017 (actual)
Primary completion: 2 Feb 2023 (actual)
Study completion: 31 May 2023 (actual)
First posted: 2 Nov 2018 (actual)
Results: Posted 13 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study team will determine whether a decreased feeding tube dwell time will reduce feeding tube contamination

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group 1--Short Dwell	Active comparator	Device: Feeding tube dwell time of 48 hoursPremature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 0-48 hours for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Group 2--Long Dwell	Active comparator	Device: Feeding tube dwell time of 7 dayPremature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 7 days for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.

Who may qualify

Ages: 30 to 40 weeks
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

be born to a mother who is at least 18 years of age and English or Spanish speaking
born at < or equal to 30 weeks
have a birthweight < or equal to 1500 grams
be born to a mother who is COVID Negative
have a feeding tube placed within 24 hours of birth

Key exclusion criteria (3 listed)

infant with known congenital GI anomalies
infants which are not expected to live
infants will be withdrawn from the study if they require abdominal surgery for GI morbidities

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Feeding tube dwell time of 48 hoursFeeding tube dwell time of 48 hours for first 4 weeks of life.	Device	Group 1--Short Dwell
Feeding tube dwell time of 7 dayFeeding tube dwell time of 7 days for first 4 weeks of life.	Device	Group 2--Long Dwell

Primary outcome

Amount of Contamination
Time frame: 24 hours
prepared solution of sectioned feeding tubes will be plated on Agar. After 24 hrs of incubation, unique colony types will be counted.

10 secondary outcomes

Gastrointestinal Inflammation - S100A12
Time frame: 4 weeks
Gastrointestinal Inflammation - Calprotectin
Time frame: 4 weeks
Hours of Parenteral Nutrition
Time frame: 4 weeks
Days With a Central Venous Line
Time frame: 4 weeks
Length of Neonatal Intensive Care Stay
Time frame: birth until discharge from the neonatal intensive care unit
Days to Reach Full Feeds
Time frame: 4 weeks
Number of Infants With Necrotizing Enterocolitis
Time frame: 4 weeks
Number of Infants With Late Onset Sepsis
Time frame: 4 weeks
Episodes of Abdominal Distension
Time frame: 4 weeks
Number of Infants With a Direct Bilirubin > 2 mg/dL
Time frame: 4 weeks

Results and safety

Results posted to the registry on 13 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1--Short Dwell	76	58
Group 2--Long Dwell	75	62

Primary outcome: Amount of Contamination

Time frame: 24 hours. Mean (Standard Deviation). Unit: Colony forming units

Measure	Group 1--Short Dwell n = 58	Group 2--Long Dwell n = 62
Value	357,000,000 (136,000,000)	4,820,000,000 (1,860,000,000)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1--Short Dwell	21 of 76 (27.6%)	0 of 76 (0%)	7 of 76
Group 2--Long Dwell	22 of 75 (29.3%)	0 of 75 (0%)	6 of 75

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Infection

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leslie Parker principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Feeding tube dwell time of 48 hours and Feeding tube dwell time of 7 day in people with Infection, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of Contamination (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03728608.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.