Premature BirthNCT04531566
Preterm Functional Early Enteral Development (FEED) Trial on Respiratory Support
A study testing Oral Feed in people with Premature Birth, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate that allowing infants that require high flow nasal cannula (HFNC)/Continuous positive airway pressure (CPAP) to orally feed if demonstrating oral cues will achieve full oral feeds faster. Read more about this study
- Who is it for?
- Ages 32 weeks and older
- Conditions the study is for
- Premature Birth
- What is being tested?
- Oral Feed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 32 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- infants that require greater than 2 litres per minute (LPM) high flow nasal canula or CPAP with a max setting of 6cm H20 FiO2 30% or less for at least 72 hours or more
- Tolerating enteral feeds of 120 ml/kg/day
Who cannot join
- Major congenital anomalies (pulmonary malformations, airway malformations, craniofacial defects, major congenital heart disease, combined pulmonary intestinal malformations)
- Metabolic disorder
- Major gastrointestinal surgeries
- Patent ductus arteriosus (PDA) ligation surgery
- Outborn deliveries greater than 7 days old
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Ashley N Morin, MD, 713-500-5800, Ashley.N.Morin@uth.tmc.edu
About this study
The purpose of this study is to demonstrate that allowing infants that require high flow nasal cannula (HFNC)/Continuous positive airway pressure (CPAP) to orally feed if demonstrating oral cues will achieve full oral feeds faster.
- Conditions
- Premature Birth
- Being tested
- Oral Feed, Usual care
- Keywords
- Prematurity, Oral Skills, Nasal CPAP oral feeds, HFNC oral feeds
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral FeedDietary supplement
Infant will be seen by occupational therapist (OT) twice a week and assessed for oral cues. If infant shows oral cues then the occupational therapist will proceed with feeding strategies. Oral feeding strategies include pacifier dips, open nipple trials with syringe controlled bolus size (1-4mls) and po trials up to 10mls.
Usual careDietary supplement
Infants will not start oral feeds until on HFNC 2 Litres or less. Oral feeds will be started on the discretion of the physician.
| Study group | Role | What they receive |
|---|---|---|
| Oral Feed Intervention Group | Experimental | Not described Receives: Dietary Supplement: Oral Feed |
| Usual care | Active comparator | Not described Receives: Dietary Supplement: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post menstrual Age (PMA) once full oral feeds are achieved as documented by not requiring gavage tube feeds for at least 24 hours
Measured in the electronic medical record
Measured: 2 months after enrollment
Secondary outcomes (12)
PMA at hospital discharge
Measured: up to 6 months after admission
PMA at completion of first oral feed
Measured: 1 month after enrollment.
length of hospitalization
Measured: up to 6 months after admission
number of gastrostomy tube
Measured: up to 6 months after admission
oxygen at discharge
Measured: up to 6 months after admission
safety outcomes during the feed as measured by the number of desaturations
Measured: 2 months after enrollment
safety outcomes during the feed as measured by the number of apnea episodes
Measured: 2 months after enrollment
safety outcomes during the feed as measured by the number of bradycardia episodes
Measured: 2 months after enrollment
safety outcomes as measured by the increase in fraction of inspired oxygen (FiO2) during and after feed
Measured: 2 months after enrollment
safety outcomes as measured by the increase in flow after feed
Measured: 2 months after enrollment
safety outcomes as measured by the number of choking episodes
Measured: 2 months after enrollment
safety outcomes as measured by the number of episodes of aspiration pneumonia
Measured: 2 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start20 Oct 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley N Morin, The University of Texas Health Science Center, Houston
- Investigators
- Ashley N Morin, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531566
- Sponsor's protocol ID
- HSC-MS-20-0741
- Status last verified
- May 2022
- First submitted
- 25 Aug 2020
- Last updated
- 23 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Functional Early Enteral Development (FEED) Trial on Respiratory Support
- ClinicalTrials.gov ID
- NCT04531566
- Acronym / sponsor ID
- HSC-MS-20-0741
- Conditions
- Premature Birth
- Keywords
- Prematurity, Oral Skills, Nasal CPAP oral feeds, HFNC oral feeds
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that allowing infants that require high flow nasal cannula (HFNC)/Continuous positive airway pressure (CPAP) to orally feed if demonstrating oral cues will achieve full oral feeds faster.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Feed Intervention Group | Experimental | Dietary Supplement: Oral Feed |
| Usual care | Active comparator | Dietary Supplement: Usual care |
Who may qualify
- Ages
- 32 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- infants that require greater than 2 litres per minute (LPM) high flow nasal canula or CPAP with a max setting of 6cm H20 FiO2 30% or less for at least 72 hours or more
- Tolerating enteral feeds of 120 ml/kg/day
Key exclusion criteria (5 listed)
- Major congenital anomalies (pulmonary malformations, airway malformations, craniofacial defects, major congenital heart disease, combined pulmonary intestinal malformations)
- Metabolic disorder
- Major gastrointestinal surgeries
- Patent ductus arteriosus (PDA) ligation surgery
- Outborn deliveries greater than 7 days old
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 |
|---|---|---|
| Oral FeedInfant will be seen by occupational therapist (OT) twice a week and assessed for oral cues. If infant shows oral cues then the occupational therapist will proceed with feeding strategies. Oral feeding strategies include pacifier dips, open nipple trials with syringe controlled bolus size (1-4mls) and po trials up to 10mls. | Dietary supplement | Oral Feed Intervention Group |
| Usual careInfants will not start oral feeds until on HFNC 2 Litres or less. Oral feeds will be started on the discretion of the physician. | Dietary supplement | Usual care |
Primary outcome
Post menstrual Age (PMA) once full oral feeds are achieved as documented by not requiring gavage tube feeds for at least 24 hours
Time frame: 2 months after enrollment
Measured in the electronic medical record
12 secondary outcomes
PMA at hospital discharge
Time frame: up to 6 months after admission
PMA at completion of first oral feed
Time frame: 1 month after enrollment.
length of hospitalization
Time frame: up to 6 months after admission
number of gastrostomy tube
Time frame: up to 6 months after admission
oxygen at discharge
Time frame: up to 6 months after admission
safety outcomes during the feed as measured by the number of desaturations
Time frame: 2 months after enrollment
safety outcomes during the feed as measured by the number of apnea episodes
Time frame: 2 months after enrollment
safety outcomes during the feed as measured by the number of bradycardia episodes
Time frame: 2 months after enrollment
safety outcomes as measured by the increase in fraction of inspired oxygen (FiO2) during and after feed
Time frame: 2 months after enrollment
safety outcomes as measured by the increase in flow after feed
Time frame: 2 months after enrollment
safety outcomes as measured by the number of choking episodes
Time frame: 2 months after enrollment
safety outcomes as measured by the number of episodes of aspiration pneumonia
Time frame: 2 months after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: No
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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.
Ashley N Morin, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Feed in people with Premature Birth, run by The University of Texas Health Science Center, Houston 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashley N Morin, MD ((713) 500-5800, Ashley.N.Morin@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post menstrual Age (PMA) once full oral feeds are achieved as documented by not requiring gavage tube feeds for at least 24 hours (time frame: 2 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2022.